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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Determine the efficacy of isolated limb infusion (ILI) with melphalan and dactinomycin in patients with primary or recurrent, unresectable regional melanoma or soft tissue sarcoma of the extremity. Determine the morbidity of patients treated with this regimen. Determine the expression of melanoma-associated antigens as well as cellular and humoral immune responses to these antigens in patients with regional disease. OUTLINE: Patients undergo fluoroscopic placement of angiographic arterial and venous catheters into the appropriate extremity. After the limb is warmed, melphalan and dactinomycin are rapidly infused into the isolated limb via the arterial catheter. Melphalan and dactinomycin are then recirculated for 20 minutes. Patients with little or no response at 8 weeks may receive up to 2 additional treatments at the discretion of the treating physician. Patients are followed at 1-2 weeks, 3-4 weeks, 6-8 weeks, and then every 3-6 months thereafter as deemed necessary by the treating physician. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within 3 years.

Official Title
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A Phase II Trial of Isolated Limb Infusion With Melphalan and Dactinomycin for Regional Melanoma and Soft Tissue Sarcoma of the Extremity

Conditions
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Sarcoma, Melanoma (Skin)

Intervention / Treatment
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* Biological: dactinomycin
* Drug: isolated limb perfusion
* Drug: melphalan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: dactinomycin|nan|
|Drug: isolated limb perfusion|nan|
|Drug: melphalan|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  |  | 
| Morbidity |  |  | 
| Expression of melanoma-associated antigens |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage III melanoma, stage IV melanoma, recurrent melanoma, stage IV adult soft tissue sarcoma