Pilot Study for Matched-Related Allogeneic Bone Marrow Transplantation for Metastatic Malignant Melanoma
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.
Primary Purpose: Treatment
Benjamin B. Weinberger, MD
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
United States: Federal Government
|Louisiana State University School of Medicine||New Orleans, Louisiana 70112-2822|