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
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|ClinicalTrials.gov Identifier: NCT00001296|
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: melphalan Drug: tumor necrosis factor Drug: interferon-gamma Procedure: hyperthermic isolated limb perfusion||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||122 participants|
|Official Title:||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|
|Study Start Date :||February 1992|
|Estimated Study Completion Date :||October 2000|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001296
|United States, Maryland|
|National Cancer Institute (NCI)|
|Bethesda, Maryland, United States, 20892|