Status:
TERMINATED
Conditioning Regimen in Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Renal Cell Cancer
Eligibility:
All Genders
Up to 65 years
Phase:
PHASE2
Brief 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 trans...
Detailed Description
Registration: When you are willing to undergo stem cell transplantation for kidney cancer, have possible related donors, and the study doctor decides you are eligible to participate, you will be enro...
Eligibility Criteria
Inclusion
- For registration: Willing to undergo allogeneic transplantation.
- For registration: Age equal to or less than 65 years old.
- For registration: Metastatic RCC with predominant conventional cell type.
- For registration: Prior nephrectomy.
- 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.
- For registration: Zubrod performance status \< one.
- For registration: Potential related donor for allogeneic stem cell transplantation.
- For registration: At least one prior treatment for metastatic RCC. Radiation therapy or surgery is not counted as a treatment.
- For registration: Signed an informed consent.
- For transplantation: Zubrod performance status \< one.
- For transplantation: An HLA-matched (defined as 6/6 matches) related donor.
- For transplantation: Failed at least one prior treatment for metastatic RCC. Radiation therapy or surgery is not counted as a treatment.
- For transplantation: Adequate major organ functions (see section 4.17-4.20).
- For transplantation: Signed an informed consent for allogeneic stem cell transplantation.
Exclusion
- For registration: Prior history of allogeneic stem cell transplantation.
- For registration: Histologic feature with predominant non-conventional cell type.
- For registration: Multiple brain metastasis.
- For registration: Life expectancy is severely limited by concomitant illness.
- For transplantation: Multiple brain metastasis.
- For transplantation: Life expectancy is severely limited by concomitant illness.
- For transplantation: Clinically significant active infections.
- For transplantation: HIV infection.
- For transplantation: Chronic active hepatitis
- For transplantation: Pregnant or lactating women.
- For transplantation: Has all three risk factors: high serum lactate dehydrogenase, low hemoglobin, high corrected serum calcium.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00429026
Start Date
January 1 2004
End Date
March 1 2008
Last Update
March 4 2013
Active Locations (1)
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1
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030