Clinical Trials

UofL Brown Cancer Center has one goal – To End Cancer

This commitment involves conducting clinical trials with the goal of helping patients live longer, healthier lives. Through clinical studies, researchers can better understand how to diagnose, treat and prevent diseases or conditions. Any time you or a loved one needs treatment for cancer, clinical trials are an option to think about. Through the clinical trials at UofL Brown Cancer Center, doctors find new ways to improve treatments and quality of life for people with cancer.

Patients have access to new treatments, sometimes those that are not available anywhere else. Trials are available for all stages of cancer. It is a myth that clinical trials are only for people who have advanced cancer that is not responding to any other treatment; our clinical trial program features trials for all stages of disease.

Our researchers and physicians design cancer trials to test new ways to treat cancer, find and diagnose cancer, prevent cancer and manage symptoms of cancer and side effects from treatment.

View the list below to learn more about active clinical trials at UofL Brown Cancer Center or call 502-562-HOPE (4673).

To learn more about qualifications and enrolling in a clinical trial:

 

16.0568 - Molecular Analysis for Therapy Choice (MATCH).

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1
 

13.0538 - A Phase I/ II Study of Hypofractionated Radiotherapy with Concurrent Temozolomide Followed by Adjuvant Temozolomide in Patients Over 70 Years Old with Newly Diagnosed Glioblastoma

Principal Investigator: Eric Burton, M.D.

Description: In this study we propose to determine outcomes of patients age 70 or older treated with radiation over 2 weeks given with temozolomide 75 mg/m2 daily during radiotherapy and as a post radiation treatment of 150 mg/m2 - 200 mg /m2 for 6 cycles or until the disease progresses.

Phase: I/II

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01985087?term=NCT01985087&rank=1
 

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the James Graham Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Goetz H Kloecker, M.D., M.S.P.H., M.B.A., F.A.C.P.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.
 

16.0742 - WIRB - METIS: Pivotal, open-label, randomized study of radiosurgery with or without Tumor Treating Fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC)    

Principal Investigator:  Eric Burton, M.D.    

Description:  The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.     

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02831959?term=NCT02831959&rank=1  
 

18.0551: A Phase II, Multicenter, Open-Label, Two-Cohort, Noncomparative Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole in Patients With PIK3CA-mutant, HR+, HER2– ABC, Whose Disease Has Progressed On or After CDK4/6 Inhibitor Treatment     

Principal Investigator:  Mounika Mandadi, M.D.    

Description: Efficacy and safety of treatment with alpelisib plus endocrine therapy in patients with HR+, HER2-negative aBC, with PIK3CA mutations, whose disease has progressed on or after CDK 4/6 treatment with an aromatase inhibitor (AI) or fulvestrant     

Phase:  II    

Additional Information: https://clinicaltrials.gov/ct2/show/NCT03056755?term=NCT03056755&rank=1

16.0568 - Molecular Analysis for Therapy Choice (MATCH).

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1
 

15.1139 - A Phase 1/2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of VT-464 in Patients with Advanced

Principal Investigator:  Elizabeth Riley, M.D., FACP

Description:  The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics and activity of VT-464, a lyase-selective inhibitor of CYP17, in patients with advanced breast cancer.

Phase:  I/II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02580448
 

15.0596 - A Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected into Liver Tumors Alone and in Combination With Systemic Pembrolizumab (MASTERKEY-318)

Principal Investigator:  Jason A Chesney, M.D., Ph.D.

Description:  This is a phase 1, multicenter, open-label trial to evaluate the safety of talimogene laherparepvec, injected intrahepatically, into liver tumors with known progression in subjects with Hepatocellular carcinoma and subjects with liver metastases from breast adenocarcinoma, colorectal adenocarcinoma, gastroesophageal cancer (adenocarcinoma or squamous cell carcinoma), melanoma, non-small cell lung cancer, or clear cell renal cell carcinoma. The study consists of 2 parts and 2 groups. Part 1 is a 3+3 dose escalation consisting of 3 sequential dose cohorts each administering talimogene laherparepvec in increasing dose concentrations and dose volumes. In Part 1, the Maximum Tolerated Dose determination of non-hepatocellular carcinoma liver metastases (Group A) will be evaluated separately from hepatocellular carcinoma (Group B), and each dose cohort will need to be deemed safe for non-hepatocellular carcinoma subjects before it will be administered in hepatocellular carcinoma subjects. Part 2 consists of expansion cohorts administering the Maximum Tolerated Dose of talimogene laherparepvec determined from Part 1 for Groups A (non-hepatocellular carcinoma) and B (hepatocellular carcinoma) to approximately 10 subjects for each tumor type.

Phase:  I

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02509507
 

15.0013 - A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy.

Principal Investigator: Mounika Mandadi, M.D.

Description:  This study investigates Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.

Phase:  III

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02032823
 

14.0936 - A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases.

Principal Investigator: Neal Dunlap, M.D.

Description: This phase I clinical trial studies the side effects and the best dose of stereotactic body radiotherapy, also known as stereotactic radiosurgery, in treating patients with breast cancer, non-small cell lung cancer, or prostate cancer that has spread to other parts of the body. Stereotactic radiosurgery delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of cancer in the body. Stereotactic radiosurgery may also kill any remaining tumor cells that are close together or close to an area previously treated with surgery while minimizing radiation exposure of surrounding normal tissue.

Phase:  I

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02206334?term=NCT02206334&rank=1

13.0631 - A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy.

Principal Investigator: Harriet Eldredge-Hindy, M.D.

Description: This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer

Phase: III

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01872975?term=NCT01872975&rank=1
 

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the James Graham Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Goetz H Kloecker, M.D., M.S.P.H., M.B.A., F.A.C.P.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

17.1181: A Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Meta Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen

Principal Investigator: Adam Rojan, M.D. 

Description: This is an open-label, multi-center, randomized, Phase 3 study designed to compare the efficacy and safety of AM0010 in combination with FOLFOX versus FOLFOX alone in patients with metastatic adenocarcinoma of the pancreas who have progressed on one prior gemcitabine containing regimen.

Phase: III

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02923921?term=NCT02923921&rank=1

18.0054: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma       

Principal Investigator: Adam Rojan, M.D.    

Description: The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA). Participants will be randomized in a 2:1 ratio to PAG or AG treatment.     

Phase: III     

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02715804?term=NCT02715804&rank=1 

16.0568 - Molecular Analysis for Therapy Choice (MATCH).

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1

15.0596 - A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected into Liver Tumors.

Principal Investigator:  Jason A Chesney, M.D., Ph.D.

Description:  This is a phase 1, multicenter, open-label trial to evaluate the safety of talimogene laherparepvec, injected intrahepatically, into liver tumors with known progression in subjects with Hepatocellular carcinoma and subjects with liver metastases from breast adenocarcinoma, colorectal adenocarcinoma, gastroesophageal cancer (adenocarcinoma or squamous cell carcinoma), melanoma, non-small cell lung cancer, or clear cell renal cell carcinoma. The study consists of 2 parts and 2 groups. Part 1 is a 3+3 dose escalation consisting of 3 sequential dose cohorts each administering talimogene laherparepvec in increasing dose concentrations and dose volumes. In Part 1, the Maximum Tolerated Dose determination of non-hepatocellular carcinoma liver metastases (Group A) will be evaluated separately from hepatocellular carcinoma (Group B), and each dose cohort will need to be deemed safe for non-hepatocellular carcinoma subjects before it will be administered in hepatocellular carcinoma subjects. Part 2 consists of expansion cohorts administering the Maximum Tolerated Dose of talimogene laherparepvec determined from Part 1 for Groups A (non-hepatocellular carcinoma) and B (hepatocellular carcinoma) to approximately 10 subjects for each tumor type.

Phase:  I

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02509507
 

14.0413 - The effect of FOLIRINOX and stereotactic body radiation therapy for locally advanced, non-resectable pancreatic cancer.

Principal Investigator: Neal Dunlap, M.D.

Description: The study will be a prospective, non-randomized, single center, trial to assess the effects of FOLIRINOX chemotherapy with SBRT on locally advanced, non-resectable pancreatic cancer. Patients will either undergo a biopsy to confirm the diagnosis or have strong clinical suspicion of a new cancer or recurrence based on the recommendations of a multi-disciplinary GI oncology team. FOLFIRINOX with be delivered prior to SBRT for 4 cycles. Restaging imaging will occur prior to SBRT delivery. SBRT will be delivered using standard stereotactic techniques to a dose of 3200cGy at 650cGy per fraction delivered over 2 weeks. Additional adjuvant chemotherapy with be delivered at the physician's discretion. Patients will be reassessed both clinically and radiographically at 3 months, 6 months, 9 months and 12 months post-treatment. Quality of life analysis will occur at 3 month intervals after treatment. Blood will be drawn for exploratory biomarker analysis at strategic timepoints during treatment and followup. Following the initial imaging time points, standard surveillance will be employed with clinical assessment and imaging at 3 month intervals for the first 2 years post-treatment.

Phase: II

Additional Information: http://clinicaltrials.gov/ct2/show/NCT02128100?term=NCT02128100&rank=1
 

13.0205 - Preemptive therapy of Cetuximab (Erbitux) induced skin rash using doxycycline, sunscreen, hydrocortisone, and moisturizer in colorectal and head and neck cancer patients.

Principal Investigator: Rebecca Redman, M.D.

Description: The purpose of this study is to determine if using preventive treatments such as Doxycycline (an anti-biotic) capsules, sunscreen with SPF 30, Hydrocortisone 1% cream and a moisturizer will help to reduce the incidence and severity of the skin rash associated with Cetuximab (Erbitux®) when compared to receiving standard care for the treatment of skin rash.

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01874860?term=NCT01874860&rank=1
 

10.0628 - Phase I Clinical Trial Investigating the Ability of Plant Exosomes to Deliver Curcumin to Normal and Malignant Colon Tissue. 

Principal Investigator: Kelli Dunn, M.D.

Description: This clinical trial will investigate the ability of plant exosomes to more effectively deliver curcumin to normal colon tissue and colon tumors. Curcumin is the yellow pigment of turmeric, a natural product with diverse biological activities. Exosomes are small endosome-derived vesicles (50-100 nanometers [nm] in size). Previous clinical trials conducted with oral curcumin have demonstrated only limited bioavailability even at very high doses of 8-12 grams per day. This trial plans to address this problem of curcumin delivery by using plant exosomes to deliver the drug to colon tumors and normal colon tissue.

Phase: I

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01294072?term=NCT01294072&rank=1
 

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the James Graham Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Goetz H Kloecker, M.D., M.S.P.H., M.B.A., F.A.C.P.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

16.1195: Phase II Randomized, Double-Blind Study of mFOLFIRINOX plus Ramucirumab versus mFOLFIRINOX plus placebo in Advanced Pancreatic Cancer Patients     

Principal Investigator: Rebecca Redman, M.D.     

Description:  This is a phase II, multicenter, double-blinded, randomized, 2-arm trial evaluating the efficacy and safety of mFOLFIRINOX plus ramucirumab (Arm A) vs. mFOLFIRINOX plus placebo (Arm B) in 94 subjects with advanced pancreatic cancer, not amenable to curative treatment. Both arms will continue treatment until disease progression or unacceptable toxicity.    

Phase:  II    

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02581215?term=NCT02581215&rank=1  
 

16.0723 - Phase 1, Two-Part, Multicenter, Non-randomized, Open-label, Multiple Dose First-in-human Study of DS-8201a, in Subjects with Advanced Solid Malignant Tumors    

Principal Investigator:  Rebecca Redman, M.D.    

Description: This is an open-label, two-part, multiple study to evaluate the safety and tolerability of DS-8201a in patients with advanced solid malignant tumors.    

Phase: I     

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02564900?term=NCT02564900&rank=1  

 

16.0568 - Molecular Analysis for Therapy Choice (MATCH).

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1

15.0596 - A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected into Liver Tumors.

Principal Investigator:  Jason A Chesney, M.D., Ph.D.

Description:  This is a phase 1, multicenter, open-label trial to evaluate the safety of talimogene laherparepvec, injected intrahepatically, into liver tumors with known progression in subjects with Hepatocellular carcinoma and subjects with liver metastases from breast adenocarcinoma, colorectal adenocarcinoma, gastroesophageal cancer (adenocarcinoma or squamous cell carcinoma), melanoma, non-small cell lung cancer, or clear cell renal cell carcinoma. The study consists of 2 parts and 2 groups. Part 1 is a 3+3 dose escalation consisting of 3 sequential dose cohorts each administering talimogene laherparepvec in increasing dose concentrations and dose volumes. In Part 1, the Maximum Tolerated Dose determination of non-hepatocellular carcinoma liver metastases (Group A) will be evaluated separately from hepatocellular carcinoma (Group B), and each dose cohort will need to be deemed safe for non-hepatocellular carcinoma subjects before it will be administered in hepatocellular carcinoma subjects. Part 2 consists of expansion cohorts administering the Maximum Tolerated Dose of talimogene laherparepvec determined from Part 1 for Groups A (non-hepatocellular carcinoma) and B (hepatocellular carcinoma) to approximately 10 subjects for each tumor type.

Phase:  I

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02509507
 

14.0936 - A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases. 

Principal Investigator: Neal Dunlap, M.D.

Description: This phase I clinical trial studies the side effects and the best dose of stereotactic body radiotherapy, also known as stereotactic radiosurgery, in treating patients with breast cancer, non-small cell lung cancer, or prostate cancer that has spread to other parts of the body. Stereotactic radiosurgery delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of cancer in the body. Stereotactic radiosurgery may also kill any remaining tumor cells that are close together or close to an area previously treated with surgery while minimizing radiation exposure of surrounding normal tissue.

Phase: Phase I

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02206334?term=NCT02206334&rank=1
 

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the James Graham Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Goetz H Kloecker, M.D., M.S.P.H., M.B.A., F.A.C.P.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

17.1155: A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, in Patients With Advanced Solid Malignancies and Lymphoma With an Expansion in Select Malignancies       

Principal Investigator: Rebecca Redman, M.D.    

Description: Study RGX-104-001 is a Phase 1, first-in-human, dose escalation and expansion study of RGX-104, an oral small molecule targeting the liver X receptor (LXR). RGX-104 activates LXR, resulting in depletion of both myeloid-derived suppressor cells (MDSCs) as well as tumor blood vessels. MDSCs block the ability of T-cells and other cells of the immune system from attacking tumors.    

Phase: I    

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02922764?term=NCT02922764&rank=1  

16.0568 - Molecular Analysis for Therapy Choice (MATCH).

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the James Graham Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Goetz H Kloecker, M.D., M.S.P.H., M.B.A., F.A.C.P.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

18.0160:  A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic or Persistent Cervical Carcinoma    

Principal Investigator:  Jason A Chesney, M.D., Ph.D.    

Description: LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI, for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma. The cell transfer therapy used in this study involves patients receiving a NMA lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.     

Phase:  II    

Additional Information: https://clinicaltrials.gov/ct2/show/NCT03108495?term=NCT03108495&rank=1  
 

18.0036:  A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes
(LN-144 or LN-145) in Patients with Solid Tumors    

Principal Investigator:  Jason A Chesney, MD, PhD

Description:  A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with pembrolizumab. TIL as a single-therapy will be evaluated with LN-145 only.    

Phase: II     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT03645928?term=NCT03645928&rank=1 
 

16.0311:  Phase II Investigation of Adjuvant Combined Cisplatin and Radiation with Pembrolizumab in Resected HNSCC    

Principal Investigator:  Neal Dunlap, M.D.    

Description: The purpose of this research study is to test the safety and the benefit of adding pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of care treatment for head and neck cancer. The standard of care treatment will include surgery followed by radiation for six weeks. Some patients may also receive cisplatin as standard of care once a week for six weeks if the cancer is found to be 'high risk'. High risk includes cancer that was not completely removed (positive margins) or cancer that has invaded through the outer lining of your lymph nodes.     

Phase: II     

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02641093?term=NCT02641093&rank=1 

17.1079:  A Phase I and Expansion Cohort Study of Adjuvant Cisplatin, Intensity-Modulated Radiotherapy, and MK-3475 (Pembrolizumab) in High-Risk Head and Neck Squamous Cell Carcinoma (HNSCC)    

Principal Investigator: Neal Dunlap, M.D.     

Description: This phase I trial studies the side effects and best dose of pembrolizumab when given together with cisplatin and intensity-modulated radiation therapy, in treating patients with stage III-IV squamous cell carcinoma of the head and neck. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Intensity-modulated radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab with cisplatin and intensity-modulated radiation therapy may work better in treating patients with squamous cell carcinoma of the head and neck.     

Phase: I     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT02775812?term=NCT02775812&rank=1   
 

17.1076: A Phase 2 Study to Evaluate the Safety and Efficacy of Cell Transfer Therapy Using Autologous Tumor Infiltrating Lymphocytes (LN-145) Followed by IL-2 in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck     

Principal Investigator:  Rebecca Redman, M.D.    

Description: LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI, for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The cell transfer therapy used in this study involves patients receiving a NMA lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.

Phase: II     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT03083873?term=NCT03083873&rank=1 
 

17.0049 - Randomized Phase III Trial Of Cisplatin-Based Chemotherapy (CRT) +/- Nivolumab (Anti-PD-1) In Patients With Intermediate And High-Risk Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma (With Phase I Lead In)       

Principal Investigator: Neal Dunlap, M.D.     

Description:  This study will evaluate the safety of adding nivolumab to several chemotherapy platforms with weekly cisplatin, high-dose cisplatin, cetuximab or radiation therapy alone    

Phase:  III    

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT02764593?term=NCT02764593&rank=1 

 

16.1173 - A randomized double-blind phase 3 study of avelumab in combination with standard of care chemo radiotherapy (cisplatin plus definitive radiation therapy) versus standard of care chemo radiotherapy in the front-line treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Description: This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.     

Phase: III     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT02952586?term=B9991016&rank=1

16.0568 - Molecular Analysis for Therapy Choice (MATCH).

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1

16.0483 - A Prospective Study of Nasociliary Function and Rhinosinusitis Symptomatology in Patients with Oropharyngeal Squamous Cell Carcinoma Receiving Intensity Modulated External Beam Radiotherapy.


Principal Investigator: Neal E. Dunlap, M.D.
 

11.0204 - A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors. 

Principal Investigator: Shiao Y Woo, M.D., F.A.C.R.

Description: A Randomized Phase II study of Adjuvant Concurrent Radiation and Chemotherapy versus Radiation alone in Resected High-Risk Malignant Salivary Gland Tumors

Phase: II

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01488838?term=NCT01488838&rank=1
 

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the James Graham Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Goetz H Kloecker, M.D., M.S.P.H., M.B.A., F.A.C.P.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

18.0068: A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of BMN 270, an Adeno-Associated Virus Vector– Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients with Residual FVIII Levels ≤ 1 IU/dL Receiving Prophylactic FVII

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This clinical trial is being conducted to learn more about a potential treatment (valoctocogene roxaparvovec) for people with severe hemophilia A. This research study will test and confirm the safety and effectiveness of the 6E13 vg/kg dose of the study drug (valoctocogene roxaparvovec) that contains the correct gene to make Factor VIII so that the body can make its own Factor VIII that functions properly. Only one dose of valoctocogene roxaparvovec is being given in this study, and this dose has been previously studied in another clinical trial in patients with hemophilia A. This is a phase 3 study which is meant to show that the study drug is safe and works to help treat hemophilia A. The study will see if liver cells are able to make Factor VIII that functions properly after receiving this study drug. The study will also examine the effects that the study drug has on how much Factor VIII concentrates patients have to inject into their veins and on their bleeding episodes after the study drug has been administered. Finally, the study will see if and how the body responds to the study drug - for example, whether liver cells become inflamed or whether the body makes antibodies (something the immune system makes to protect itself against things like bacteria and viruses) against the vector or the new Factor VIII gene

Phase: III

Additional Information: https://clinicaltrials.gov/ct2/show/NCT03370913?term=NCT03370913&rank=1

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the James Graham Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Goetz H Kloecker, M.D., M.S.P.H., M.B.A., F.A.C.P.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

18.0042: A Prospective Non-Interventional Study of Bleeding Episodes, Factor VIII Infusions, and Patient-Reported Outcomes in Individuals with Severe Hemophilia A     

Principal Investigator:  Vivek Sharma, M.D.,  F.A.C.P.    

Description: To document the number and type of bleeding episodes in severe HA patients under routine clinical practice and to estimate the number of bleeding episodes over time.  

16.0568 - Molecular Analysis for Therapy Choice (MATCH)

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1

15.1013 - A Phase Ib/II Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination with Polatuzumab Vedotin and Venetoclax in Patients with Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma.

Principal Investigator: Robert V. Emmons, M.D., F.A.C.P.

Description:  This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment with obinutuzumab, polatuzumab vedotin, and venetoclax in participants with relapsed or refractory FL or DLBCL. Participants with FL who achieve complete response (CR), partial response (PR), or stable disease (SD) at the end of induction therapy will receive post-induction treatment with obinutuzumab and venetoclax, and participants with DLBCL who achieve CR or PR at the end of induction will also be eligible for post-induction treatment.

Phase:  Ib/II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02611323
 

15.0574 - Phase II Trial of Intravenous Fenretinide (N-(4-hydroxyphenyl retinamide, 4-HPRa) Emulsion for Patients with Relapsed/Refractory Peripheral T-cell Lymphomas (PTCL).

Principal Investigator:  William Tse, M.D.

Description:  This study addresses the hypothesis that intermittent treatment with fenretinide intravenous emulsion will induce objective responses in patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL) who have failed at least two prior systemic therapy and will result in acceptable toxicities.

Phase:  II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02495415
 

12.0471 - A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients.

Principal Investigator: William Tse, M.D.

Description: This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.

Phase: II

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01656603?term=NCT01656603&rank=1
 

11.0445 - A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications.

Principal Investigator: William Tse, M.D.

Description: This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.  The primary aim of this study is to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licensed.

Phase: N/A

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01351545?term=NCT01351545&rank=1
 

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the James Graham Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Goetz H Kloecker, M.D., M.S.P.H., M.B.A., F.A.C.P.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

03.0165 - NMDP Research Sample Repository for Allogeneic Unrelated Hematopoietic Stem Cell Transplantation.

Description: This protocol will collect blood samples and medical information from patients who have had a bone marrow transplant using cells from an unrelated donor identified through the National Marrow Donor Program (NMDP).  Patients who have received a bone marrow transplant at the NIH or other institution from an unrelated donor affiliated with the NMDP may be eligible for this study

 Additional Information: http://clinicaltrials.gov/ct2/show/NCT00495300?term=NCT00495300&rank=1

03.0158 - National Marrow Donor Program Research Database for Hematopoietic Stem Cell Transplantation.

Description: The primary purpose of the Research Database is to have a comprehensive source of observational data that can be used to study HSC transplantation.   A secondary purpose of the Research Database is to have a comprehensive source of data to study marrow toxic injuries.

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01166009?term=NCT01166009&rank=1
 

17.0586 - A Randomized, Double-Blind Phase 3 Study of Ibrutinib in Combination With Corticosteroids versus Placebo in Combination With Corticosteroids in Subjects with New Onset Chronic Graft Versus Host Disease (cGVHD)     

Principal Investigator:  William Tse, M.D.    

Description: To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.

Phase:  III    

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02959944?term=NCT02959944&rank=1  

17.0269:  A multicenter, randomized, open-label Phase 2 study evaluating the safety and
efficacy of three different regimens of oral panobinostat in combination with subcutaneous bortezomib and oral dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma who have been previously exposed to immunomodulatory agents.    

Principal Investigator: Robert V. Emmons, M.D., F.A.C.P.    

Description:  The purpose of this study is to investigate the safety and efficacy of three different regimens of PAN (20 mg TIW, 20 mg BIW, and 10 mg TIW) in combination with s.c. BTZ and Dex and to provide exposure, safety and efficacy data to identify the optimal regimen of PAN in a randomized, 3-arm parallel design. This study will also assess the impact of administering s.c. BTZ (in combination with PAN and Dex) twice weekly for 4 cycles, and then weekly starting from Cycle 5 until disease progression in patients ≤ 75 years of age. Patients > 75 years of age will receive for the entire treatment period s.c. BTZ weekly (in combination with PAN and Dex) until disease progression.    

Phase: II     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT02654990?term=NCT02654990&rank=1 
 

18.0175: Phase II Study of Consolidation Immunotherapy with Nivolumab and Ipilimumab or Nivolumab alone following Concurrent Chemoradiotherapy for Unresectable Stage IIIA/IIIB Non-small Cell Lung Cancer (NSCLC)     

Principal Investigator: Goetz H Kloecker, M.D., M.S.P.H., M.B.A., F.A.C.P.   

Description: This study is an open label, multicenter, randomized phase II trial of consolidation immunotherapy with either nivolumab alone or the combination of nivolumab and ipilimumab following concurrent chemoradiation in patients with unresectable stage III NSCLC.     

Phase: II    

Additional Information: https://clinicaltrials.gov/ct2/show/NCT03285321?term=NCT03285321&rank=1 

18.0036:  A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes
(LN-144 or LN-145) in Patients with Solid Tumors    

Principal Investigator:  Jason A Chesney, MD, PhD

Description:  A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with pembrolizumab. TIL as a single-therapy will be evaluated with LN-145 only.    

Phase: II     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT03645928?term=NCT03645928&rank=1 

18.0623: A randomized phase II/III trial. Maintenance systemic therapy versus consolidative stereotactic body radiation therapy (SBRT) plus maintenance systemic therapy for limited metastatic non-small cell lung cancer (NSCLC).

Principal Investigator: Neal Dunlap, M.D.     

Description: This randomized phase II/III trial studies how well giving maintenance chemotherapy with or without stereotactic body radiation therapy works in treating patients with stage IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving maintenance chemotherapy and stereotactic body radiation therapy together may work better than maintenance chemotherapy alone in treating patients with stage IV non-small cell lung cancer.     

Phase: II/III     

Additional Information: https://clinicaltrials.gov/ct2/show/NCT03137771?term=NCT03137771&rank=1 

16.0679 - Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) - A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-small Cell Lung Cancers.

Principal Investigator:  Goetz H Kloecker, M.D., M.S.P.H., M.B.A., F.A.C.P.

Description: To evaluate whether adjuvant therapy with nivolumab will result in improved overall survival (OS) and/or disease-free survival (DFS) over standard observation in patients with stage IB>=4 cm, II and IIIA, non-small cell lung cancer (NSCLC) following surgical resection and standard adjuvant therapy.

Phase:  III

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02595944?term=EA5142&rank=1

16.0568 - Molecular Analysis for Therapy Choice (MATCH).

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.II

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1

15.1138 - A Randomized Phase III Study of Sublobar Resection (SR) versus Stereotactic Ablative Radiotherapy (SAbR) in High Risk Patients with Stage I Non-Small Cell Lung Cancer (NSCLC).

Principal Investigator:  Neal Dunlap, M.D.

Description:  Pre-randomized trial- Patients will be screened and pre-randomized to either SR or SAbR. Informed consent will be obtained after patients are made aware of the randomized assignment. Despite pre-randomization prior to consent, patients maintain their right to accept or decline any/all study activities. Only consenting patients will be allowed to participate in study activities, including observation after either randomized treatments or observation after standard of care treatment, while those declining consent will be managed by their physician(s) off study.

Phase:  III

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02468024
 

15.0596 - A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected into Liver Tumors.

IRB Number:  15.0596

Principal Investigator:  Jason A Chesney, M.D., Ph.D.

Description:  This is a phase 1, multicenter, open-label trial to evaluate the safety of talimogene laherparepvec, injected intrahepatically, into liver tumors with known progression in subjects with Hepatocellular carcinoma and subjects with liver metastases from breast adenocarcinoma, colorectal adenocarcinoma, gastroesophageal cancer (adenocarcinoma or squamous cell carcinoma), melanoma, non-small cell lung cancer, or clear cell renal cell carcinoma. The study consists of 2 parts and 2 groups. Part 1 is a 3+3 dose escalation consisting of 3 sequential dose cohorts each administering talimogene laherparepvec in increasing dose concentrations and dose volumes. In Part 1, the Maximum Tolerated Dose determination of non-hepatocellular carcinoma liver metastases (Group A) will be evaluated separately from hepatocellular carcinoma (Group B), and each dose cohort will need to be deemed safe for non-hepatocellular carcinoma subjects before it will be administered in hepatocellular carcinoma subjects. Part 2 consists of expansion cohorts administering the Maximum Tolerated Dose of talimogene laherparepvec determined from Part 1 for Groups A (non-hepatocellular carcinoma) and B (hepatocellular carcinoma) to approximately 10 subjects for each tumor type.

Phase:  I

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02509507
 

15.0493 - Randomized Phase 3 Assessment of Second Line Treatment with Plinabulin + Docetaxel Compared to Docetaxel in Patients with Advanced Non-Small Cell Lung Cancer with at Least 1 Large Lung Lesion.

Principal Investigator:  Goetz H Kloecker, M.D., M.S.P.H., M.B.A., F.A.C.P.

Description: The primary purpose of the study is to compare the overall survival of NSCLC patients receiving second- or third-line chemotherapy with docetaxel + plinabulin (DP Arm) to patients treated with docetaxel + placebo (D Arm) for advanced or metastatic disease.     

Phase: III     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT02504489?term=BPI-2358-103&rank=1

15.0122 - CIRB - A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein.

Principal Investigator:  Goetz H Kloecker, M.D., M.S.P.H., M.B.A., F.A.C.P.

Description:  This randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called ALK. Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Tumors with this mutation may respond to treatments that target the mutation, such as crizotinib. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. It is not yet known if crizotinib may be an effective treatment for treating non-small cell lung cancer with an ALK fusion mutation.

Phase:  III

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02201992

15.0121 - CIRB - Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC).

Principal Investigator:  Goetz H Kloecker, M.D., M.S.P.H., M.B.A., F.A.C.P.

Description:  This randomized phase III trial studies how well erlotinib hydrochloride compared to placebo works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Phase:  III

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02193282

15.0075 - Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST).

Principal Investigator:  Goetz H Kloecker, M.D., M.S.P.H., M.B.A., F.A.C.P.

Description:  This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02194738

14.0936 - A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases. 

Principal Investigator: Neal Dunlap, M.D.

Description: This phase I clinical trial studies the side effects and the best dose of stereotactic body radiotherapy, also known as stereotactic radiosurgery, in treating patients with breast cancer, non-small cell lung cancer, or prostate cancer that has spread to other parts of the body. Stereotactic radiosurgery delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of cancer in the body. Stereotactic radiosurgery may also kill any remaining tumor cells that are close together or close to an area previously treated with surgery while minimizing radiation exposure of surrounding normal tissue.

Phase: I

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02206334?term=NCT02206334&rank=1
 

13.0337 - The effect of pentoxifylline and Vitamin E in preventing radiation-induced toxicity in the treatment of recurrent or new primary non-small cell lung cancers using stereotactic ablative radiotherapy (SABR) in patients previously treated with thoracic radiation.

Principal Investigator: Neal Dunlap, M.D. 

Description: The objective of this prospective phase II protocol is to assess the toxicity and efficacy of pentoxifylline and SABR in the re-treatment of recurrent or new lung cancers.

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01871454?term=NCT01871454&rank=1
 

09.0451, 00337 - Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer also Receiving Cisplatin and Etoposide.

Principal Investigator: Neal Dunlap, M.D.

Description: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which radiation therapy regimen is more effective when given together with chemotherapy in treating patients with limited-stage small cell lung cancer. This randomized phase III trial is comparing different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.

Phase: III

Additional Information: http://clinicaltrials.gov/ct2/show/NCT00632853?term=NCT00632853&rank=1
 

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the James Graham Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Goetz H Kloecker, M.D., M.S.P.H., M.B.A., F.A.C.P.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

08.0041 - Beta-glucan`s Immuno-modulatory Effect on Non-Small Cell Lung Cancer.

Principal Investigator: Goetz H Kloecker, M.D., M.S.P.H., M.B.A., F.A.C.P.

Description: The purpose of this study is to determine how beta-glucan affects the immune system in subjects with non-small cell lung cancer.

Phase: Pilot/Feasibility

Additional Information: http://clinicaltrials.gov/ct2/show/NCT00682032?term=NCT00682032&rank=1

17.0276 - A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)        

Principal Investigator:  Goetz H Kloecker, M.D., M.S.P.H., M.B.A., F.A.C.P.    

Description: This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.     

Phase: III     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT03033511?term=NCT03033511&rank=1 
 

17.0087 - A Randomized, Open-label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared With Topotecan for High DLL3 Expressing Small Cell Lung Cancer (SCLC) Subjects With First Relapse/Recurrence Following Front-Line Platinum-Based Chemotherapy (TAHOE)      

Principal Investigator: Goetz H Kloecker, M.D., M.S.P.H., M.B.A., F.A.C.P.     

Description:  The purpose of this randomized, open-label, 2-arm, Phase 3 study is to assess the assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic Small Cell Lung Cancer (SCLC) with high levels of delta-like protein 3 (DLL3) and who have first disease progression during or following front-line platinum-based chemotherapy.    

Phase:  III    

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT03061812?term=NCT03061812&rank=1 
 

18.0082: A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combination with Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)     

Principal Investigator:  Jason A Chesney, M.D., Ph.D.    

Description: LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of up to 6 doses of IL-2. Patients in Cohort 2 will also receive durvalumab Q4Weeks until progression or unacceptable toxicity.     

Phase:  II    

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT03419559?term=NCT03419559&rank=1  
 

18.0036:  A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes
(LN-144 or LN-145) in Patients with Solid Tumors    

Principal Investigator:  Jason A Chesney, MD, PhD

Description:  A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with pembrolizumab. TIL as a single-therapy will be evaluated with LN-145 only.    

Phase: II     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT03645928?term=NCT03645928&rank=1 

16.0817 - A Phase 2, Multicenter, Single-arm Study to Assess the Safetyand Efficacy of Cell Transfer Therapy Using Autologous Tumor Infiltrating Lymphocytes (LN-144) Followed by IL-2 for Treatment of Patients with Metastatic Melanoma.

Principal Investigator:  Jason A Chesney, M.D., Ph.D.

Description:  LN-144 is a cell transfer therapy and is based on current TIL therapy regimens originally developed by the NCI for the treatment of patients with metastatic melanoma. The cell transfer therapy used in this study involves patients receiving a lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2. Patients will be evaluated for response approximately 12 weeks following the LN-144 therapy. Patients will receive one course of treatment.    

Phase: II     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT02360579?term=C-144-01&rank=1
 

16.0568 - Molecular Analysis for Therapy Choice (MATCH).

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1

16.0332 - A Randomized Phase III trial of Dabrafenib + Trametinib followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab followed by Dabrafenib + Trametinib at Progression in Patients With Advanced BRAFV600 Mutant Melanoma.

Principal Investigator: Jason A Chesney, M.D., Ph.D.

Description: This randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a mutation known as v-raf murine sarcoma viral oncogene homolog B V600 (BRAFV600) and cannot be removed by surgery. Ipilimumab and nivolumab may block tumor growth by targeting certain cells. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.  

Phase: III     

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02224781?term=EA6134&rank=1
 

15.1029 - A Randomized,Phase II Trial of Intermittent Versus Continuous Dosing of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAFV600E/K Mutant Melanoma.

Principal Investigator:  Donald M Miller, M.D., Ph.D.

Description:  This randomized phase II trial studies how well dabrafenib and trametinib work in treating patients with stage III-IV melanoma that cannot be removed by surgery and contains a B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutation. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Phase:  II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02196181
 

15.0596 - A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected into Liver Tumors.

Principal Investigator:  Jason A Chesney, M.D., Ph.D.

Description:  This is a phase 1, multicenter, open-label trial to evaluate the safety of talimogene laherparepvec, injected intrahepatically, into liver tumors with known progression in subjects with Hepatocellular carcinoma and subjects with liver metastases from breast adenocarcinoma, colorectal adenocarcinoma, gastroesophageal cancer (adenocarcinoma or squamous cell carcinoma), melanoma, non-small cell lung cancer, or clear cell renal cell carcinoma. The study consists of 2 parts and 2 groups. Part 1 is a 3+3 dose escalation consisting of 3 sequential dose cohorts each administering talimogene laherparepvec in increasing dose concentrations and dose volumes. In Part 1, the Maximum Tolerated Dose determination of non-hepatocellular carcinoma liver metastases (Group A) will be evaluated separately from hepatocellular carcinoma (Group B), and each dose cohort will need to be deemed safe for non-hepatocellular carcinoma subjects before it will be administered in hepatocellular carcinoma subjects. Part 2 consists of expansion cohorts administering the Maximum Tolerated Dose of talimogene laherparepvec determined from Part 1 for Groups A (non-hepatocellular carcinoma) and B (hepatocellular carcinoma) to approximately 10 subjects for each tumor type.

Phase:  I

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02509507
 

14.0465 - A Phase I/II Trial of Dabrafenib, Trametinib and Metformin Administered to Unresectable Stage IIIC and Stage IV Melanoma Patients.

Principal Investigator:Jason A Chesney, M.D., Ph.D.

Description: The main purpose is to evaluate the clinical response, safety and survival of the FDA approved drugs Dabrafenib, Trametinib in combination with Metformin. Investigators hypothesize that the combination of an FDA approved non toxic dose of oral Metformin with the B-Raf inhibitor, Dabrafenib and the MEK inhibitor, Trametinib will yield little toxicity and improve clinical outcomes in terms of objective response rates and survival in metastatic melanoma patients.

Phase: I/II

Additional Information: http://clinicaltrials.gov/ct2/show/NCT02143050?term=NCT02143050&rank=1
 

12.0171 - A Phase I/II Trial of Vemurafenib and Metformin Administered to Unresectable Stage IIIC and Stage IV BRAF.V600E+ Melanoma Patients.

Principal Investigator: Jason A Chesney, M.D., Ph.D.

Description: The main purpose of this study is to evaluate the safety of Vemurafenib in combination with Metformin in melanoma patients. The phase II part of the study will also evaluate the clinical activity of the combined regiment. Based on pre-clinical studies and a phase I trial, the investigators hypothesize that the combination of an FDA-approved non-toxic dose of oral Metformin with Vemurafenib will yield little toxicity and improve clinical outcomes in terms of objective response rates and survival in metastatic melanoma patients.

Phase: I/II

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01638676?term=NCT01638676&rank=1
 

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the James Graham Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Goetz H Kloecker, M.D., M.S.P.H., M.B.A., F.A.C.P.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

17.0073 - Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim
versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma    

Principal Investigator:  Jason A. Chesney, M.D., Ph.D.    

Description: This randomized phase II/III trial studies the side effects and best dose of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may kill tumor cells by blocking blood flow to the tumor, by stimulating white blood cells to kill the tumor cells, or by attacking specific tumor cells and stop them from growing or kill them. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.     

Phase:  II/III    

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT02339571?term=ea6141&rank=1