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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004250
• Other study ID #: 99-047
• Secondary ID: MSKCC-99047NCI-G
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2000
• Last updated: January 15, 2013
• Start date: August 1999

Study information

• Verified date: January 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)
• Sarcoma

Intervention

Biological:
• dactinomycin

Drug:
• isolated limb perfusion

• melphalan

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Brady 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: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy			No
Primary	Morbidity			No
Primary	Expression of melanoma-associated antigens			No