Clinical trial NCT00004250: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma (Skin)
Sarcoma
Keywords: 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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Efficacy
measure: Morbidity
measure: Expression of melanoma-associated antigens
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mary S. Brady, MD
role: STUDY_CHAIR
References:
citation: 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: 10.1097/CMR.0b013e32832985e3.