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
Completed · Phase 3
Conditions studied: Melanoma
In brief
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.
Key facts
- Study ID
- NCT00001296
- Run by
- National Cancer Institute (NCI)
- People needed
- 122
- Starts
- 1992-02-01
- Expected to finish
- 2000-10-01
- Last updated by the study team
- 2008-03-04
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
Where it is running
- National Cancer Institute (NCI) — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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