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
Information source: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Melanoma
Intervention: melphalan (Drug); tumor necrosis factor (Drug); interferon-gamma (Drug); hyperthermic isolated limb perfusion (Procedure)
Phase: Phase 3
Status: Completed
Sponsored by: National Cancer Institute (NCI)
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.
Clinical Details
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 design: Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
National Cancer Institute (NCI), Bethesda, Maryland 20892, United States
Additional Information
Related publications: Karakousis CP, Choe KJ, Holyoke ED. Biologic behavior and treatment of intransit metastasis of melanoma. Surg Gynecol Obstet. 1980 Jan;150(1):29-32.
Starting date: February 1992
Last updated: March 3, 2008
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