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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 is a Phase 1 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 136 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00091104
The ClinicalTrials.gov registry entry for NCT00091104 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 136 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.
NCT00091104 reports 0 study locations.
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.
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