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


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin), Sarcoma

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy

Safety Issue:

No

Principal Investigator

Mary S. Brady, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

99-047

NCT ID:

NCT00004250

Start Date:

August 1999

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • Sarcoma
  • 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
  • Melanoma
  • Sarcoma

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021