A Phase 3 interventional study of melphalan and tumor necrosis factor in Melanoma, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2008-03-04.
Sponsored by National Cancer Institute (NCI) · Phase 3, Interventional, and Treatment
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.
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 122 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
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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.
This study is completed, as verified in Nov 1999. You cannot join it, but the record below documents what was studied.
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