Melanoma (Skin) Clinical Trial
Official title:
Pilot Study for Matched-Related Allogeneic Bone Marrow Transplantation for Metastatic Malignant Melanoma
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.
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.
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