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NCT00706992 · ClinicalTrials.gov registry record · Phase 2
Anti-MART-1 F5 Lymphocytes to Treat High-Risk Melanoma Patients
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT00706992: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00706992 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00706992, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
Background: * Melanoma antigen recognized by T cells (MART-1) is a gene that is present in melanoma cells. * This study tests an experimental treatment that uses the patient's own lymphocytes (type of white blood cell), which are specially selected and genetically modified with a gene called anti-MART-1 transduced cells (F5) to target and destroy their tumor. Some of the cells are given as an infusion and others are given as a vaccine. * The anti-MART-1 F5 cells are currently being studied in other patients in combination with chemotherapy and IL-2 (aldesleukin) therapy. Objectives: -To determine if the anti-MART-1 F5 treatment can improve the immune system's ability to shrink tumors and to prevent melanoma from recurring. Eligibility: * Patients 18 years of age and older whose melanoma has been removed and are currently disease-free, but who are at risk for recurrence. * Patients who do not have ocular or mucosal melanoma. * Patients with tissue type human leukocyte antigens (HLA-A)\*0201). Design: * Workup: Patients have scans, x-rays, laboratory tests, other tests as needed and leukapheresis, a procedure for collecting white cells to modify in the laboratory and later reinfuse into the patient. * Patients are assigned to one of four study groups: * Group 1 receives anti-MART-1 F5 cells by 30-minute infusion through a vein on day 0. * Group 2 receives anti-MART-1 F5 cells on day 0 followed by injections of MART-1 vaccine, which contains MART-1 and an oil-based liquid called Montanide ISA-51 VG. The vaccine is repeated on day 30. * Group 3 receives anti-MART-1 F5 cells on day 0 followed by injections of low-dose IL-2 for 5 days (days 0-4). * Group 4 receives anti-MART-1 F5 cells on day 0 followed by MART-1 vaccine and low-dose IL-2 for 5 days. The vaccine is repeated on day 30. * Recovery: Patients are monitored closely and given medicines to prevent or treat any side effects of therapy. * Leukapheresis: Patients undergo leukapheresis at 1 and 3 mon
Interventions
- BIOLOGICAL Aldesleukin
- BIOLOGICAL incomplete Freund's adjuvant
- BIOLOGICAL ALVAC-MART-1 vaccine
- BIOLOGICAL MART-1:26-35(27L) peptide vaccine
- BIOLOGICAL autologous anti-MART-1 F5 T-cell receptor gene-engineered peripheral blood lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2008-06 |
| Est. Completion | 2012-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00706992
The ClinicalTrials.gov registry entry for NCT00706992 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 50 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 Aldesleukin is the first listed.
NCT00706992 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00706992 about?
NCT00706992 is a clinical study titled "Anti-MART-1 F5 Lymphocytes to Treat High-Risk Melanoma Patients". Background: * Melanoma antigen recognized by T cells (MART-1) is a gene that is present in melanoma cells. * This study tests an experimental treatment that uses the patient's own lymphocytes (type of white blood cell), which are specially selected and genetically modified with a gene called anti-M...
What is the current status of trial NCT00706992?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2008-06. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00706992?
The interventions under investigation include: Aldesleukin (BIOLOGICAL), incomplete Freund's adjuvant (BIOLOGICAL), ALVAC-MART-1 vaccine (BIOLOGICAL), MART-1:26-35(27L) peptide vaccine (BIOLOGICAL), autologous anti-MART-1 F5 T-cell receptor gene-engineered peripheral blood lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT00706992?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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