Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Metastatic Kidney Cancer
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.
Biological: therapeutic allogeneic lymphocytes
Drug: fludarabine phosphate
Procedure: peripheral blood stem cell transplantation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Allogeneic Stem Cell Transplantation of Renal Cell Cancer and Metastatic Melanoma After Non-Myeloablative Chemotherapy|
- Complete Response Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 1999|
|Study Completion Date:||August 2007|
|Primary Completion Date:||October 2004 (Final data collection date for primary outcome measure)|
Experimental: Arm A
Fludarabine 30 mg/m2/d x S days IVPB in 100 cc NS over 30 minutes on day -8, -7, -6, -S, and -4. Cyclophosphamide 2 gm/m2/d x 2 days IVPB in SOO cc DS W over I hour on day -3 and day-2. G-CSF (Neupogen®) administration 480 f!gld subcutaneously starting on day +5 (or first day of neutropenia if earlier)and continued until an ANC of 0.5 x 109/L is maintained for 3 consecutive days.
|Biological: filgrastim Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: fludarabine phosphate Procedure: peripheral blood stem cell transplantation|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004135
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|Study Chair:||Todd M. Zimmerman, MD||University of Chicago|