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 - Tabular View

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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

This study has been completed.

Study NCT00001296. Last updated on March 3, 2008. Information provided by National Institutes of Health Clinical Center (CC)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief 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
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
Brief 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.
Detailed Description	Patients with locally advanced melanoma confined to an extremity (Stage IIIA or Stage IIIAB) will be treated in a randomized Phase III study with hyperthermic isolated limb perfusion. One arm of the study will be a standard 60 minute perfusion with melphalan as a single agent. The second arm of the study will combine melphalan, tumor necrosis factor, and interferon-gamma in the isolated limb perfusion reproducing a regimen shown to have 100% response rates in a Phase II European trial. Patients will be followed for local response rates, duration of response, treatment toxicity, and disease-free survival.
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Melanoma
Intervention ^†	Drug: melphalan Drug: tumor necrosis factor Drug: interferon-gamma Procedure: hyperthermic isolated limb perfusion
MEDLINE PMIDs	7350699
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	122
Start Date ^†	February 1992
Completion Date	October 2000
Eligibility Criteria ^†	DISEASE CHARACTERISTICS: Biopsy-proven Stage IIIA or IIIAB melanoma (M.D. Anderson staging system) of an extremity, as follows: Advanced local disease indicated by 2 or more satellite or in-transit metastases. Lower limb regional metastases must be distal to the apex of the femoral triangle except inguinal lymph node metastases. Upper limb regional metastases must be distal to the deltoid insertion except axillary lymph node metastases. No evidence of systemic disease outside the involved extremity. Recurrent disease subsequent to prior successful limb perfusion allowed. Bidimensional directly measurable dermal or subcutaneous lesion required. PRIOR/CONCURRENT THERAPY: No prior isolated limb perfusion. Biologic Therapy: At least 1 month since Biologic Therapy. At least 3 months since regional therapy of the extremity. Chemotherapy: At least 1 month since chemotherap.y At least 3 months since regional therapy of the extremity. Endocrine Therapy: Not specified. Radiotherapy: At least 1 month since radiotherapy. Surgery: Not specified. PATIENT CHARACTERISTICS: Age: 18 and over. Performance status: ECOG 0 or 1. Hematopoietic: Platelets greater than 150,000. Hepatic: Bilirubin less than 1.5 mg/dl; Coagulation profile normal. Renal: Creatinine less than 2.0 mg/dl. Cardiovascular: No evidence of peripheral vascular disease, e.g.: No history of claudication. OTHER: HIV negative. No pregnant or nursing women.
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00001296
Organization ID	920105
Secondary IDs ^††	92-C-0105
Study Sponsor ^†	National Cancer Institute (NCI)
Collaborators ^††
Investigators ^†
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	November 1999
First Received Date ^†	November 3, 1999
Last Updated Date	March 3, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.