Conditioning Regimen in Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Summary
Primary Objectives: 1. To compare the overall survival of metastatic renal cell carcinoma (RCC) patients undergoing HLA-matched related donor nonmyeloablative allogeneic hematopoietic stem cell transplantation (NST) using fludarabine-melphalan (FM) versus fludarabine-cyclophosphamide (FC) conditioning regimen. 2. To assess both cytotoxic T lymphocyte reactivity and antibodies activity against potential tumor antigenic peptides involved in graft-versus-RCC effect. Secondary Objectives: 1. To study the patient characteristics of metastatic RCC patients who undergo NST and those who do not undergo NST. 2. To compare the incidence of Day-100 treatment-related mortality in FM group and FC group.
Timeline
- Start
- 2004-01
- Primary completion
- 2008-03
- Completion
- 2008-03
Outcome
Outcome not reported
Stopped (Enrollment): “Slow accrual, study terminated.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Subject | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |
| Subject | Melphalan | Small molecule | 70 mg/m2 | Intravenous |