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Allogeneic Stem Cell Transplantation of Renal Cell Cancer and Metastatic Melanoma After Non-Myeloablative Chemotherapy
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients who have metastatic kidney cancer or melanoma.
OBJECTIVES: * Evaluate the safety of nonmyeloablative chemotherapy followed by allogeneic peripheral blood stem cell transplantation in patients with metastatic renal cell carcinoma or melanoma. * 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 counts recover. 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 discretion. 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 years.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Start Date
February 1, 1999
Primary Completion Date
October 1, 2004
Completion Date
August 1, 2007
Last Updated
March 7, 2014
19
ACTUAL participants
filgrastim
BIOLOGICAL
therapeutic allogeneic lymphocytes
BIOLOGICAL
cyclophosphamide
DRUG
fludarabine phosphate
DRUG
peripheral blood stem cell transplantation
PROCEDURE
Lead Sponsor
University of Chicago
Collaborators
NCT00026884
NCT07485114
Data Source & Attribution
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