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NCT00001296 · ClinicalTrials.gov registry record · Phase 3

A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion With Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients With Locally Advanced Extremity Melanoma

A Phase 3 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 3
Development phase
122
Enrollment target

NCT00001296: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).

NCT00001296 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 122 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00001296, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 3
Development phase
122 participants
Enrollment target

Study Summary

Randomized study. Initially, 3 patients will be entered on Arm I as a pilot feasibility study and to standardize the technical aspects of the study. Subsequently, all patients are randomized to Arms I and II. Arm I: Regional Hyperthermia plus Regional Single-Agent Chemotherapy. Hyperthermic intravenous limb perfusion, HILP; plus Melphalan, L-PAM, NSC-8806. Arm II: Regional Hyperthermia plus Regional Single-Agent Chemotherapy and Biological Response Modifier Therapy. HILP as in Arm I; plus L-PAM; and Tumor Necrosis Factor (Knoll), TNF, NSC-635257; Interferon gamma (Genentech), IFN-G, NSC-600662.

Interventions

  • DRUG melphalan
  • DRUG interferon-gamma
  • DRUG tumor necrosis factor
  • PROCEDURE hyperthermic isolated limb perfusion

Trial Details

FieldValue
Enrollment Target 122 participants
Start Date 1992-02
Est. Completion 2000-10
Phase Phase 3
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00001296 record still lists

NCT00001296 is an interventional study that assigns participants to a tested intervention. The registered 122 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 (84% lower).

The record links to 0 conditions, and to 4 interventions - of which melphalan is the first listed.

NCT00001296 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00001296 about?

NCT00001296 is a clinical study titled "A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion With Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients With Locally Advanced Extremity Melanoma". Randomized study. Initially, 3 patients will be entered on Arm I as a pilot feasibility study and to standardize the technical aspects of the study. Subsequently, all patients are randomized to Arms I and II. Arm I: Regional Hyperthermia plus Regional Single-Agent Chemotherapy. Hyperthermic intrave...

What is the current status of trial NCT00001296?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 122 participants. The study started on 1992-02. Estimated completion is 2000-10.

What interventions are being tested in trial NCT00001296?

The interventions under investigation include: melphalan (DRUG), interferon-gamma (DRUG), tumor necrosis factor (DRUG), hyperthermic isolated limb perfusion (PROCEDURE).

Who is sponsoring clinical trial NCT00001296?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00001296's enrollment target sits among peer trials

122 1617th of 2000 higher than 382 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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Source: ClinicalTrials.gov NCT00001296, the US trial registry maintained by the National Library of Medicine. NCT00001296 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.