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NCT00062036 · ClinicalTrials.gov registry record · Phase 1
Cyclophosphamide and Fludarabine Followed By Interleukin-2 Gene-Modified Tumor Infiltrating Lymphocytes 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
- 33
- Enrollment target
NCT00062036 is a Phase 1 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 33 participants.
The verdict
NCT00062036, a Phase 1 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy such as cyclophosphamide and fludarabine use different ways to stop tumor cells from dividing so they stop growing or die. Inserting the gene for interleukin-2 into a person's tumor infiltrating lymphocytes may make the body build an immune response to kill tumor cells. Combining cyclophosphamide and fludarabine with gene-modified tumor cells may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of gene-modified tumor infiltrating lymphocytes when given together with cyclophosphamide and fludarabine and to see how well they work in patients with metastatic melanoma (phase I is closed to accrual 3/29/06).
Interventions
- BIOLOGICAL aldesleukin
- BIOLOGICAL filgrastim
- BIOLOGICAL incomplete Freund's adjuvant
- BIOLOGICAL therapeutic tumor infiltrating lymphocytes
- BIOLOGICAL interleukin-2 gene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2003-06 |
| Est. Completion | 2008-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00062036
The ClinicalTrials.gov registry entry for NCT00062036 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 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 aldesleukin is the first listed.
NCT00062036 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00062036 about?
NCT00062036 is a clinical study titled "Cyclophosphamide and Fludarabine Followed By Interleukin-2 Gene-Modified Tumor Infiltrating Lymphocytes in Treating Patients With Metastatic Melanoma". RATIONALE: Drugs used in chemotherapy such as cyclophosphamide and fludarabine use different ways to stop tumor cells from dividing so they stop growing or die. Inserting the gene for interleukin-2 into a person's tumor infiltrating lymphocytes may make the body build an immune response to kill tumo...
What is the current status of trial NCT00062036?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2003-06. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00062036?
The interventions under investigation include: aldesleukin (BIOLOGICAL), filgrastim (BIOLOGICAL), incomplete Freund's adjuvant (BIOLOGICAL), therapeutic tumor infiltrating lymphocytes (BIOLOGICAL), interleukin-2 gene (BIOLOGICAL).
Who is sponsoring clinical trial NCT00062036?
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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