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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Keywords

ClinConnect Summary

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-...

Gender

ALL

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.