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NCT00138229 · ClinicalTrials.gov registry record · Phase 2
Cyclophosphamide and Fludarabine Followed By an Autologous Lymphocyte Infusion and Interleukin-2 in Treating Patients With Refractory or Recurrent Metastatic Melanoma
A Phase 2 study, sponsored by National Institutes of Health Clinical Center (CC).
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT00138229: Clinical Trial Phase 2 study, sponsored by National Institutes of Health Clinical Center (CC).
NCT00138229 is a Phase 2 study that was terminated before completion, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00138229, a Phase 2 study, was terminated before completion, sponsored by National Institutes of Health Clinical Center (CC).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
RATIONALE: An infusion of a patient's lymphocytes that have been treated in the laboratory to remove certain immune cells may be an effective treatment for melanoma. Drugs, such as cyclophosphamide and fludarabine, may suppress the immune system so that the patient's immune cells allow the infused lymphocytes to work. Interleukin-2 may help the lymphocytes kill more tumor cells when they are put back in the body. Giving cyclophosphamide and fludarabine followed by an autologous lymphocyte infusion and interleukin-2 may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine followed by an autologous lymphocyte infusion and interleukin-2 works in treating patients with refractory or recurrent melanoma.
Interventions
- DRUG cyclophosphamide
- DRUG fludarabine phosphate
- BIOLOGICAL therapeutic autologous lymphocytes
- BIOLOGICAL aldesleukin
- BIOLOGICAL filgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2005-07 |
| Est. Completion | 2007-04 |
| Phase | Phase 2 |
Why NCT00138229 stopped before completion
NCT00138229 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00138229 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00138229 about?
NCT00138229 is a clinical study titled "Cyclophosphamide and Fludarabine Followed By an Autologous Lymphocyte Infusion and Interleukin-2 in Treating Patients With Refractory or Recurrent Metastatic Melanoma". RATIONALE: An infusion of a patient's lymphocytes that have been treated in the laboratory to remove certain immune cells may be an effective treatment for melanoma. Drugs, such as cyclophosphamide and fludarabine, may suppress the immune system so that the patient's immune cells allow the infused l...
What is the current status of trial NCT00138229?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2005-07. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00138229?
The interventions under investigation include: cyclophosphamide (DRUG), fludarabine phosphate (DRUG), therapeutic autologous lymphocytes (BIOLOGICAL), aldesleukin (BIOLOGICAL), filgrastim (BIOLOGICAL).
Who is sponsoring clinical trial NCT00138229?
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 NCT00138229's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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