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NCT00003789 · ClinicalTrials.gov registry record · Phase 3
Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melanoma of the Arm or Leg
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 216
- Enrollment target
NCT00003789: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00003789 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 216 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003789, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 216 participants
- Enrollment target
Study Summary
Randomized phase III trial to compare the effectiveness of hyperthermic isolated limb perfusion of melphalan with or without tumor necrosis factor in treating patients who have locally advanced melanoma of the arm or leg. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Heating melphalan to several degrees above body temperature and infusing it only to the area around the tumor may kill more tumor cells. It is not yet known whether combining melphalan with tumor necrosis factor is more effective than melphalan alone in treating melanoma.
Primary Outcome
Response will be calculated based on the 3-month follow-up assessment of presence of absence of complete response. This will be done using the logistic regression model.
Interventions
- OTHER laboratory biomarker analysis
- OTHER pharmacological study
- DRUG melphalan
- DRUG isolated limb perfusion
- BIOLOGICAL recombinant tumor necrosis factor family protein
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 1999-03 |
| Phase | Phase 3 |
What the finished NCT00003789 record still lists
NCT00003789 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT00003789 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00003789 about?
NCT00003789 is a clinical study titled "Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melanoma of the Arm or Leg". Randomized phase III trial to compare the effectiveness of hyperthermic isolated limb perfusion of melphalan with or without tumor necrosis factor in treating patients who have locally advanced melanoma of the arm or leg. Drugs used in chemotherapy use different ways to stop tumor cells from dividin...
What is the current status of trial NCT00003789?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 216 participants. The study started on 1999-03.
What interventions are being tested in trial NCT00003789?
The interventions under investigation include: laboratory biomarker analysis (OTHER), pharmacological study (OTHER), melphalan (DRUG), isolated limb perfusion (DRUG), recombinant tumor necrosis factor family protein (BIOLOGICAL).
Who is sponsoring clinical trial NCT00003789?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00003789's enrollment target sits among peer trials
216 1332nd of 2000 higher than 667 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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