Clinical trial · Interventional
Isolated Limb Infusion of Chemotherapy in Treating Patients With Melanoma or Soft Tissue Sarcoma of the Arm or Leg That Cannot Be Removed By Surgery
A Phase II Trial of Isolated Limb Infusion With Melphalan and Dactinomycin for Regional Melanoma and Soft Tissue Sarcoma of the Extremity
- 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Infusing chemotherapy to the tumor area only may kill more tumor cells and cause less damage to healthy tissues. PURPOSE: This phase II trial is studying isolated limb infusion of chemotherapy to see how well it works in treating patients with melanoma or soft tissue sarcoma of the arm or leg that cannot be removed by surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dactinomycin | Biological | Dactinomycin | ALIAS |
| isolated limb perfusion | Drug | — | UNRESOLVED |
| melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Efficacy
- measure
- Morbidity
- measure
- Expression of melanoma-associated antigens
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven primary or recurrent, regional melanoma or soft tissue sarcoma that is not amenable to surgical resection * Majority (greater than 95%) of disease must be distal to the apex of the femoral triangle in the lower limb and the deltoid insertion in the upper limb * Bidimensionally measurable disease in the extremity * Patients with disease beyond the limb are eligible if their extremity disease requires palliative treatment in the judgment of their physician PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * Karnofsky 70-100% Life expectancy: * At least 6 months Hematopoietic: * WBC at least 3,000/mm\^3 Hepatic: * Not specified Renal: * Creatinine less than 2.0 mg/dL Cardiovascular: * Must have palpable femoral/axillary, dorsalis pedis/popliteal, or radial pulses in the extremity to be treated * No signs or symptoms of vascular insufficiency (no history of claudication or other ischemic peripheral vascular disease) Other: * Not pregnant or nursing * Negative pregnancy test * No other concurrent serious illness * No severe diabetes * No prior extremity complications due to diabetes PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * At least 4 weeks since prior antitumor therapy and recovered * At least 2 weeks since prior antibiotics
References
Publications (1)
- RESULTBrady MS, Brown K, Patel A, Fisher C, Marx W. Isolated limb infusion with melphalan and dactinomycin for regional melanoma and soft-tissue sarcoma of the extremity: final report of a phase II clinical trial. Melanoma Res. 2009 Apr;19(2):106-11. doi: 10.1097/CMR.0b013e32832985e3. PMID 19282789