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NCT00610311 · ClinicalTrials.gov registry record · Phase 2
Anti-gp100 Cells Plus ALVAC gp100 Vaccine to Treat Advanced Melanoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT00610311: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00610311 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00610311, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
Background: * gp100 is a protein that is often found in melanoma tumors. * An experimental procedure developed for treating patients with melanoma uses anti-gp100 cells designed to destroy their tumors. The anti-gp100 cells are created in the laboratory using the patient's own tumor cells or blood cells. * The treatment procedure also uses a vaccine called plaque purified canarypox vector (ALVAC) gp100, made from a virus that ordinarily infects canaries and is modified to carry a copy of the gp100 gene. The virus cannot reproduce in mammals, so it cannot cause disease in humans. When the vaccine is injected into a patient, it stimulates cells in the immune system that may increase the efficiency of the anti gp 100 cells. Objectives: -To evaluate the safety and effectiveness of anti-gp100 cells and the ALVAC gp100 vaccine in treating patients with advanced melanoma. Eligibility: -Patients with metastatic melanoma for whom standard treatments have not been effective. Design: * Patients undergo scans, x-rays and other tests and leukapheresis to obtain white cells for laboratory treatment. * Patients have 7 days of chemotherapy to prepare the immune system for receiving the gp100 cells. * Patients receive the ALVAC vaccine, anti-gp100 cells and interleukin-2 (IL-2) (an approved treatment for advanced melanoma). The anti gp100 cells are given as an infusion through a vein. The vaccine is given as injections just before the infusion of gp100 cells and again 2 weeks later. IL-2 is given as a 15-minute infusion every 8 hours for up to 5 days after the cell infusion for a maximum of 15 doses. * After hospital discharge, patients return to the clinic for periodic follow-up with a physical examination, review of treatment side effects, laboratory tests and scans every 1 to 6 months.
Primary Outcome
Clinical tumor response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is a 30% decrease in lesions taking as reference the baseline sum longest diameter (LD). For details about the RECIST criteria see the protocol link module.
Interventions
- DRUG cyclophosphamide
- BIOLOGICAL Aldesleukin
- DRUG fludarabine phosphate
- BIOLOGICAL ALVAC gp100 Vaccine
- BIOLOGICAL anti-gp100:154-162 Tcell receptor (TCR) peripheral blood lymphocyte (PBL)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2008-01 |
| Est. Completion | 2011-02 |
| Phase | Phase 2 |
Why NCT00610311 stopped before completion
NCT00610311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00610311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00610311 about?
NCT00610311 is a clinical study titled "Anti-gp100 Cells Plus ALVAC gp100 Vaccine to Treat Advanced Melanoma". Background: * gp100 is a protein that is often found in melanoma tumors. * An experimental procedure developed for treating patients with melanoma uses anti-gp100 cells designed to destroy their tumors. The anti-gp100 cells are created in the laboratory using the patient's own tumor cells or blood ...
What is the current status of trial NCT00610311?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2008-01. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00610311?
The interventions under investigation include: cyclophosphamide (DRUG), Aldesleukin (BIOLOGICAL), fludarabine phosphate (DRUG), ALVAC gp100 Vaccine (BIOLOGICAL), anti-gp100:154-162 Tcell receptor (TCR) peripheral blood lymphocyte (PBL) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00610311?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00610311's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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