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NCT00091104 · ClinicalTrials.gov registry record · Phase 1
Cyclophosphamide and Fludarabine Followed by Vaccine Therapy, Gene-Modified White Blood Cell Infusions, and Aldesleukin 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
- 136
- Enrollment target
NCT00091104: Completed Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
NCT00091104 is a Phase 1 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 136 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (127% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00091104, a Phase 1 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 136 participants
- Enrollment target
Study Summary
RATIONALE: Inserting a laboratory-treated gene into a person's white blood cells may make the body build an immune response to kill tumor cells. Giving cyclophosphamide and fludarabine before a white blood cell infusion may suppress the immune system and allow tumor cells to be killed. Vaccines may make the body build an immune response to kill tumor cells. Aldesleukin may stimulate a person's white blood cells to kill tumor cells. Combining white blood cell infusion with vaccine therapy and aldesleukin may cause a stronger immune response and kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of gene-modified white blood cells when given together with cyclophosphamide, fludarabine, vaccine therapy, and aldesleukin and to see how well it works in treating patients with metastatic melanoma.
Interventions
- BIOLOGICAL therapeutic autologous lymphocytes
- BIOLOGICAL aldesleukin
- BIOLOGICAL filgrastim
- BIOLOGICAL incomplete Freund's adjuvant
- BIOLOGICAL MART-1:27-35 peptide vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2004-07 |
| Est. Completion | 2010-10 |
| Phase | Phase 1 |
What the finished NCT00091104 record still lists
NCT00091104 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (127% higher).
The record links to 0 conditions, and to 5 interventions - of which therapeutic autologous lymphocytes is the first listed.
NCT00091104 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00091104 about?
NCT00091104 is a clinical study titled "Cyclophosphamide and Fludarabine Followed by Vaccine Therapy, Gene-Modified White Blood Cell Infusions, and Aldesleukin in Treating Patients With Metastatic Melanoma". RATIONALE: Inserting a laboratory-treated gene into a person's white blood cells may make the body build an immune response to kill tumor cells. Giving cyclophosphamide and fludarabine before a white blood cell infusion may suppress the immune system and allow tumor cells to be killed. Vaccines may ...
What is the current status of trial NCT00091104?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 136 participants. The study started on 2004-07. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00091104?
The interventions under investigation include: therapeutic autologous lymphocytes (BIOLOGICAL), aldesleukin (BIOLOGICAL), filgrastim (BIOLOGICAL), incomplete Freund's adjuvant (BIOLOGICAL), MART-1:27-35 peptide vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00091104?
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 NCT00091104's enrollment target sits among peer trials
136 422nd of 2000 higher than 1,576 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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