Melanoma Clinical Trial
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
Summary
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.
Full Description
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.
Eligibility Criteria
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
New York New York, 10021, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.