Conditioning Regimen in Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Terminated
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Melphalan; Vidarabine

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.