Vemurafenib and White Blood Cell Therapy for Advanced Melanoma

Stopped early · Phase 1

Conditions studied: Metastatic Cancer, Melanoma

In brief

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.

Key facts

Study ID

NCT01585415

Run by

National Cancer Institute (NCI)

People needed

12

Starts

2012-04-09

Expected to finish

2016-07-21

Last updated by the study team

2019-11-21

Who can join

Age: 18 and older, up to 66. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Prior cell transfer therapy which included a myeloablative chemotherapy regimen (i.e. 1200 TBI or 200 TBI plus chemotherapy).
• Previous treatment with Vemurafenib.
• Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
• Systemic steroid therapy requirement.
• Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
• Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
• Opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
• History of severe immediate hypersensitivity reaction to any of the agents used in this study.
• History of coronary revascularization or ischemic symptoms.
• Any patient known to have an LVEF less than or equal to 45 percent.
• In patients > 60 years old, documented LVEF of less than or equal to 45 percent.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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