Allogeneic Peripheral Blood Progenitor Cell Transplantation in Patients With Incurable Solid Tumors: A Phase I Study
OBJECTIVES: I. Determine the toxicity of allogeneic peripheral blood stem cell
transplantation in patients with metastatic or unresectable small cell lung cancer, breast
cancer, testicular germ cell cancer, melanoma, or renal cell cancer. II. Determine the
efficacy of this regimen in these patients.
OUTLINE: Donors receive filgrastim (G-CSF) subcutaneously for 4 or 5 days prior to
peripheral blood stem cell harvest. Patients are assigned to one of three conditioning
regimens, depending on disease. Group A (small cell lung cancer): Patients receive
cyclophosphamide IV over 1-2 hours on days -7 and -6, etoposide IV over 4 hours on day -5,
and total body irradiation twice daily on days -4 to -1. Group B (breast cancer and
testicular germ cell cancer): Patients receive oral busulfan every 6 hours on days -7 to -4
for a total of 14 doses. Patients then receive cyclophosphamide IV over 1-2 hours on days -3
and -2. Group C (renal cell cancer and melanoma): Patients receive fludarabine IV daily on
days -8 to -4 and cyclophosphamide IV on days -3 and -2. All groups: Patients receive
allogeneic peripheral blood stem cells IV over 10-20 minutes on day 0. Patients are followed
weekly for 3 months, at 6 and 12 months, and then yearly for 5 years.
PROJECTED ACCRUAL: A total of 19-42 patients will be accrued for this study.
Primary Purpose: Treatment
Richard K. Burt, MD
Robert H. Lurie Cancer Center
United States: Federal Government