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NCT00085462 · ClinicalTrials.gov registry record · Phase 1
Gene-Modified White Blood Cells Followed By Interleukin-2 and Vaccine Therapy in Treating Patients With Metastatic Melanoma
A Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT00085462: Completed Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
NCT00085462 is a Phase 1 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00085462, a Phase 1 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
Study Summary
RATIONALE: Inserting a gene that has been created in the laboratory into a person's white blood cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Vaccines may make the body build an immune response to kill tumor cells. Combining gene-modified white blood cell infusions with interleukin-2 and vaccine therapy may kill more tumor cells. PURPOSE: This phase I trial is studying how well giving gene-modified white blood cells when given together with interleukin-2 and vaccine therapy works in treating patients with metastatic melanoma.
Interventions
- BIOLOGICAL therapeutic autologous lymphocytes
- BIOLOGICAL aldesleukin
- BIOLOGICAL filgrastim
- BIOLOGICAL therapeutic tumor infiltrating lymphocytes
- BIOLOGICAL gp100-fowlpox vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2004-05 |
| Est. Completion | 2008-09 |
| Phase | Phase 1 |
What the finished NCT00085462 record still lists
NCT00085462 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which therapeutic autologous lymphocytes is the first listed.
NCT00085462 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00085462 about?
NCT00085462 is a clinical study titled "Gene-Modified White Blood Cells Followed By Interleukin-2 and Vaccine Therapy in Treating Patients With Metastatic Melanoma". RATIONALE: Inserting a gene that has been created in the laboratory into a person's white blood cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Vaccines may make the body build an immune response to k...
What is the current status of trial NCT00085462?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2004-05. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00085462?
The interventions under investigation include: therapeutic autologous lymphocytes (BIOLOGICAL), aldesleukin (BIOLOGICAL), filgrastim (BIOLOGICAL), therapeutic tumor infiltrating lymphocytes (BIOLOGICAL), gp100-fowlpox vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00085462?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00085462's enrollment target sits among peer trials
61 828th of 2000 higher than 1,170 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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