Conditioning Regimen in Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Condition: Renal Cell Cancer
MeSH terms: Carcinoma, Renal Cell
Intervention: Fludarabine; Melphalan; Cyclophosphamide; Stem Cell Transplant
Intervention description: 25 mg/m^2 intravenous (IV) daily for 5 Days; 70 mg/m^2 IV Daily for 2 Days; 60 mg/kg IV Daily for 2 Days; Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using HLA-Matched Related Donor
Intervention MeSH terms: Cyclophosphamide; Melphalan; Fludarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Kidney Cancer; Renal Cell Cancer; Stem Cell Transplant; Cyclophosphamide; Fludarabine; Melphalan; NST

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. For registration: Willing to undergo allogeneic transplantation.

          2. For registration: Age equal to or less than 65 years old.

          3. For registration: Metastatic RCC with predominant conventional cell type.

          4. For registration: Prior nephrectomy.

          5. For registration: Stage IV RCC. If patient has prior single brain metastasis treated
             with complete surgical resection or stereotactic radiation therapy, no recurrence or
             brain edema from the end of treatment for at least 6 months has to be shown by
             radiological imaging.

          6. For registration: Zubrod performance status < one.

          7. For registration: Potential related donor for allogeneic stem cell transplantation.

          8. For registration: At least one prior treatment for metastatic RCC. Radiation therapy
             or surgery is not counted as a treatment.

          9. For registration: Signed an informed consent.

         10. For transplantation: Zubrod performance status < one.

         11. For transplantation: An HLA-matched (defined as 6/6 matches) related donor.

         12. For transplantation: Failed at least one prior treatment for metastatic RCC. Radiation
             therapy or surgery is not counted as a treatment.

         13. For transplantation: Adequate major organ functions (see section 4.17-4.20).

         14. For transplantation: Signed an informed consent for allogeneic stem cell
             transplantation.

        Exclusion Criteria:

          1. For registration: Prior history of allogeneic stem cell transplantation.

          2. For registration: Histologic feature with predominant non-conventional cell type.

          3. For registration: Multiple brain metastasis.

          4. For registration: Life expectancy is severely limited by concomitant illness.

          5. For transplantation: Multiple brain metastasis.

          6. For transplantation: Life expectancy is severely limited by concomitant illness.

          7. For transplantation: Clinically significant active infections.

          8. For transplantation: HIV infection.

          9. For transplantation: Chronic active hepatitis

         10. For transplantation: Pregnant or lactating women.

         11. For transplantation: Has all three risk factors: high serum lactate dehydrogenase, low
             hemoglobin, high corrected serum calcium.