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
OBJECTIVES: I. Determine the response rate and survival of patients with metastatic
malignant melanoma who have failed first-line therapy when treated with match-related
allogeneic bone marrow transplantation.
OUTLINE: This is a pilot study. Patients receive a preparative regimen of busulfan and
cyclophosphamide. Busulfan PO is administered every 6 hours on days -7 to -4.
Cyclophosphamide IV is administered on days -3 to -2 followed by one day of rest. Bone
marrow infusion occurs on day 0. Cyclosporine begins on day -1 and continues until day 180.
Methotrexate IV is administered on days 1, 3, 6, and 11. Granulocyte colony-stimulating
factor is administered as a continuous IV every 2 hours starting on day 12 and continuing
until absolute neutrophil count is greater than 1,000 g/dL for 2 consecutive days. Patients
receive weekly follow up for the first 180 days and monthly thereafter. Patients are
followed until death.
PROJECTED ACCRUAL: 6 patients with melanoma will be accrued.
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
PRIOR CONCURRENT THERAPY: At least 1 prior standard regimen for metastatic disease