Vemurafenib and White Blood Cell Therapy for Advanced Melanoma
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|ClinicalTrials.gov Identifier: NCT01585415|
Recruitment Status : Terminated
First Posted : April 25, 2012
Last Update Posted : November 21, 2019
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Melanoma||Drug: Vemurafenib Biological: Young TIL Drug: Cyclophosphamide Drug: Fludarabine Drug: Aldesleukin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Trial of the Combination of Vemurafenib With Adoptive Cell Therapy in Patients With Metastatic Melanoma|
|Study Start Date :||April 9, 2012|
|Actual Primary Completion Date :||July 21, 2016|
|Actual Study Completion Date :||July 21, 2016|
Experimental: Single Arm
Two weeks prior to the start of the preparative regimen, patients will begin taking vemurafenib. Patients will then receive lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine, followed by young TIL and high dose aldesleukin
Vemurafenib will administered orally twice a day at a dose of 960 mg from day -21 (+/- 7 days)until disease progression or patients are taken off protocol.
Biological: Young TIL
Young TIL will be administered intravenously on day 0(1x10e9 to 2x10e11) in the Patient Care Unit over 20-30 minutes via non-filtered tubing, gently agitating the bag during infusion to prevent cell clumping.
Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
Aldeskeukin 720,000 IU/kg IV (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)
- 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. [ Time Frame: approximately 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)|