Overview

Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Metastatic Melanoma

Status:
Terminated
Trial end date:
2001-02-22
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Clinical trial to study the effectiveness of chemotherapy plus bone marrow transplantation in treating patients with metastatic melanoma that has not responded to previous therapy.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Louisiana State University Health Sciences Center Shreveport
Treatments:
Busulfan
Cyclophosphamide
Cyclosporine
Cyclosporins
Methotrexate
Criteria
DISEASE CHARACTERISTICS: Biopsy proven relapsed malignant melanoma that has failed prior
standard regimen for metastatic disease Must have HLA-matched or related bone marrow donor
(5- or 6-antigen match) No history of CNS metastases

PATIENT CHARACTERISTICS: Age: 16 to 44 Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: Not specified Hepatic: SGOT and SGPT less than 1.5 times
upper limit of normal Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL
AND/OR Creatinine clearance greater than 75 mL/min Cardiovascular: No history of cardiac
disease No symptomatic cardiac disease Ejection fraction greater than 50% Pulmonary: FEV1
greater than 50% predicted (greater than 75% if received thoracic irradiation) DLCO greater
than 50% predicted Other: Not pregnant Fertile women must use effective contraception HIV
negative No active bacterial, fungal, or viral infection Hepatitis B negative

PRIOR CONCURRENT THERAPY: At least 1 prior standard regimen for metastatic disease