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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: Completed Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).

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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 33 participants
Start Date 2003-06
Est. Completion 2008-09
Phase Phase 1

What the finished NCT00062036 record still lists

NCT00062036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).

The record links to 0 conditions, and to 5 interventions - of which aldesleukin is the first listed.

NCT00062036 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00062036's enrollment target sits among peer trials

33 1280th of 2000 higher than 705 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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Source: ClinicalTrials.gov NCT00062036, the US trial registry maintained by the National Library of Medicine. NCT00062036 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.