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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00004250

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma (Skin) Sarcoma	Biological: dactinomycin Drug: isolated limb perfusion Drug: melphalan	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 1999

Actual Primary Completion Date :

Jun 1, 2007

Outcome Measures

Primary Outcome Measures

Efficacy []
Morbidity []
Expression of melanoma-associated antigens []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)