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NCT01585415 · ClinicalTrials.gov registry record · Phase 1
Vemurafenib and White Blood Cell Therapy for Advanced Melanoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01585415: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01585415 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01585415, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study 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.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Aldesleukin
- BIOLOGICAL Young TIL
- DRUG Vemurafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-04-09 |
| Est. Completion | 2016-07-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01585415
The ClinicalTrials.gov registry entry for NCT01585415 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01585415 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01585415 about?
NCT01585415 is a clinical study titled "Vemurafenib and White Blood Cell Therapy for Advanced Melanoma". 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 vemurafen...
What is the current status of trial NCT01585415?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2012-04-09. Estimated completion is 2016-07-21.
What interventions are being tested in trial NCT01585415?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Aldesleukin (DRUG), Young TIL (BIOLOGICAL), Vemurafenib (DRUG).
Who is sponsoring clinical trial NCT01585415?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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