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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

Primary Purpose

Melanoma (Skin), Sarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dactinomycin
isolated limb perfusion
melphalan
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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) 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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Efficacy
Morbidity
Expression of melanoma-associated antigens

Secondary Outcome Measures

Full Information

First Posted
January 28, 2000
Last Updated
January 15, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004250
Brief Title
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
dactinomycin
Intervention Type
Drug
Intervention Name(s)
isolated limb perfusion
Intervention Type
Drug
Intervention Name(s)
melphalan
Primary Outcome Measure Information:
Title
Efficacy
Title
Morbidity
Title
Expression of melanoma-associated antigens

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary S. Brady, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19282789
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.
Results Reference
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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

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