Status:
COMPLETED
Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Melanoma
Sarcoma
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
Hyperthermic isolated limb perfusion with melphalan alone is administered as a double perfusion schedule. These two isolates limb perfusions with melphalan are treated 3-6 weeks apart. After perfusio...
Detailed Description
Patients with extremity melanoma (Stage IIIA, IIIAB or Stage IV disease who have bulky symptomatic tumor located in the extremity) or patients with unresectable extremity sarcoma will undergo a double...
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed unresectable sarcoma or intransit melanoma of the upper or lower extremity.
Extremity sarcoma with no local resection option and would require amputation based upon abutment or proximity of the tumor to major neurovascular structures or bone or joint structures.
MELANOMA PATIENTS:
Must have history of two or more satellite intransit metastases of which one may be excised for diagnosis with the exception of patients with a single, large, deep, locally recurrent tumor or metastatic tumor (greater than 5 cm) that precludes an excision with primary closure. Stage IV melanoma must have a significant component (greater than 90%) of disease distal to the apex of the femoral triangle in the lower limb or distal to the insertion of the deltoid in the upper limb.
Must have evaluable disease in the extremity. Melanoma must have dermal or subcutaneous lesion that can be measure directly in two diameters to assess tumor burden. Sarcoma must have either cutaneous lesions amenable to direct measurement or deeper lesions that can be measured on CT or MRI scans.
PRIOR/CONCURRENT THERAPY:
At least 2 months since any regional therapy to the affected extremity.
BIOLOGIC THERAPY: At least 1 month since Biologic Therapy.
CHEMOTHERAPY: At least 1 month since chemotherapy.
ENDOCRINE THERAPY: Not specified.
RADIOTHERAPY: At least 1 month since radiotherapy.
SURGERY: Not specified.
PATIENT CHARACTERISTICS:
AGE: 18 and over.
PERFORMANCE STATUS: ECOG 0-2.
LIFE EXPECTANCY: At least 6 months.
HEMATOPOIETIC: Platelet count greater than 150,000/mm(3).
HEPATIC: Bilirubin less than 2.0 mg/dL.
RENAL: Creatinine less than 2.0 mg/dL.
CARDIOVASCULAR: No history of congestive heart failure with an LVEF less than 40%.
PULMONARY:
No chronic obstructive pulmonary disease.
No other chronic pulmonary disease with PFTs less than 50% predicted for age.
OTHER:
IF HIV POSITIVE: Must have CD4 cell count greater than 500/mL and, No clinical manifestations of AIDS. Coagulation parameters no greater than 1-2 seconds within the upper limit of normal.
No evidence of severe peripheral vascular disease.
No history of claudication or other ischemic vascular disease.
Not pregnant or nursing.
Key Trial Info
Start Date :
June 1 1997
Trial Type :
INTERVENTIONAL
End Date :
March 1 2000
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00001577
Start Date
June 1 1997
End Date
March 1 2000
Last Update
March 4 2008
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892