Allogeneic Stem Cell Transplantation of Renal Cell Cancer and Metastatic Melanoma After Non-Myeloablative Chemotherapy
- Evaluate the safety of nonmyeloablative chemotherapy followed by allogeneic peripheral
blood stem cell transplantation in patients with metastatic renal cell carcinoma or
- Determine the incidence and severity of all adverse events related to this treatment
regimen in this patient population.
- Determine the efficacy of this treatment regimen in terms of tumor regression, response
duration, progression free survival, and overall survival in these patients.
- Measure the resulting chimerism and immune reconstitution in these patients after this
treatment regimen and correlate with clinical response.
OUTLINE: Patients receive fludarabine IV over 30 minutes on days -8 through -4 and
cyclophosphamide IV over 1 hour on days -3 and -2. Immediately following each daily donor
leukapheresis, patients receive allogeneic peripheral blood stem cells (PBSC) IV over 15
minutes beginning on day 0 and continuing until the target cells are collected. Patients
receive filgrastim (G-CSF) subcutaneously beginning on day 5 and continuing until blood
If no graft versus host disease has developed within 4 weeks of allogeneic PBSC
transplantation, patients with disease progression or recurrence who have residual donor
hematopoiesis on chimerism analysis may receive donor T lymphocytes IV over 30 minutes.
Patients may receive an additional course of donor T lymphocytes at the investigator's
Patients are followed at days 30 and 100, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 10-38 patients will be accrued for this study within 2.5
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete Response Rate
Todd M. Zimmerman, MD
University of Chicago
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|