Vemurafenib and White Blood Cell Therapy for Advanced Melanoma
- One possible treatment for advanced melanoma involves collecting white blood cells from the person with cancer and growing them in a laboratory. The cells can then be given back to the donor. This study will use this white blood cell treatment with the cancer treatment drug vemurafenib. Vemurafenib targets melanoma cells that have a mutation in the B-raf gene, and may be able to make them shrink.
- To see if vemurafenib and white blood cell therapy is a safe and effective treatment for advanced melanoma.
- Individuals at least 18 years and less than or equal to 66 years of age who have advanced melanoma that contains the B-raf genetic mutation.
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
- White blood cells will be collected from tumor cells. These cells will be collected during surgery or a tumor biopsy.
- Participants will have leukapheresis to collect additional white blood cells for the procedure.
- Participants will take vemurafenib twice a day, starting 3 weeks before receiving the white blood cells.
- Participants will have 1 week of chemotherapy to prepare their immune system to accept the white blood cells.
- Participants will receive an infusion of their collected white blood cells. They will also receive aldesleukin for up to 5 days to boost the immune system s response to the white blood cells. They will remain in the hospital until they have recovered from the treatment.
- Participants will have frequent follow-up visits to monitor the outcome of the treatment.
Drug: Young TIL
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Trial of the Combination of Vemurafenib With Adoptive Cell Therapy in Patients With Metastatic Melanoma|
- Determine the safety of the administration of vemurafenib in conjunction with ACT consisting of autologous TIL infused along with high dose aldesleukin following a non-myeloablative lymphodepleting preparative regimen.
- Gain preliminary information concerning the ability of combination therapy to mediate clinical tumor regression patients with metastatic melanoma.
- Study the immunologic impact of VEM administration on the lymphoid infiltrate in melanoma deposits.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01585415
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Steven A Rosenberg, M.D.||National Cancer Institute (NCI)|