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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004250
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 16, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

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:


  • 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 Type : Interventional  (Clinical Trial)
Estimated 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 : August 1999
Actual Primary Completion Date : June 2007

Primary Outcome Measures :
  1. Efficacy
  2. Morbidity
  3. Expression of melanoma-associated antigens

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Over 18

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 6 months


  • WBC at least 3,000/mm^3


  • Not specified


  • Creatinine less than 2.0 mg/dL


  • 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)


  • Not pregnant or nursing
  • Negative pregnancy test
  • No other concurrent serious illness
  • No severe diabetes

    • No prior extremity complications due to diabetes


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • At least 4 weeks since prior antitumor therapy and recovered
  • At least 2 weeks since prior antibiotics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004250

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Mary S. Brady, MD Memorial Sloan Kettering Cancer Center

Publications of Results: Identifier: NCT00004250     History of Changes
Other Study ID Numbers: 99-047
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
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

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Connective and Soft Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Protein Synthesis Inhibitors
Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors