Isolated Limb Infusion of Chemotherapy in Treating Patients With Melanoma or Soft Tissue Sarcoma … (NCT00004250) | Clinical Trial Compass
CompletedPhase 2
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
United States35 participantsStarted 1999-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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