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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. According to ClinicalTrials.gov, the official US trial registry.

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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

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00001296

The ClinicalTrials.gov registry entry for NCT00001296 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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

NCT00001296 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.