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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 is a Phase 1 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 61 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00085462
The ClinicalTrials.gov registry entry for NCT00085462 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which therapeutic autologous lymphocytes is the first listed.
NCT00085462 reports 0 study locations.
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.
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