Vemurafenib and White Blood Cell Therapy for Advanced Melanoma
Status:
Terminated
Trial end date:
2016-07-21
Target enrollment:
Participant gender:
Summary
Background:
- 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.
Objectives:
- To see if vemurafenib and white blood cell therapy is a safe and effective treatment for
advanced melanoma.
Eligibility:
- 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.
Design:
- 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.