Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hyperthermic isolated limb perfusion | Procedure | — | UNRESOLVED |
| interferon-gamma | Drug | — | UNRESOLVED |
| melphalan | Drug | Melphalan | ALIAS |
| tumor necrosis factor | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDKarakousis CP, Choe KJ, Holyoke ED. Biologic behavior and treatment of intransit metastasis of melanoma. Surg Gynecol Obstet. 1980 Jan;150(1):29-32. PMID 7350699