Vemurafenib and White Blood Cell Therapy for Advanced Melanoma
Public ClinicalTrials.gov record NCT01585415. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Pilot Trial of the Combination of Vemurafenib With Adoptive Cell Therapy in Patients With Metastatic Melanoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01585415
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 12 participants
Conditions and interventions
Conditions
Interventions
- Vemurafenib Drug
- Young TIL Biological
- Cyclophosphamide Drug
- Fludarabine Drug
- Aldesleukin Drug
Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years to 66 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 8, 2012
- Primary completion
- Jul 20, 2016
- Completion
- Jul 20, 2016
- Last update posted
- Nov 20, 2019
2012 – 2016
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01585415, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 20, 2019 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01585415 live on ClinicalTrials.gov.