Conditioning Regimen in Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
This study has been terminated.
(Slow accrual, study terminated.)
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00429026
First received: January 29, 2007
Last updated: February 26, 2013
Last verified: February 2013
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Purpose
Primary Objectives:
- 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.
- To assess both cytotoxic T lymphocyte reactivity and antibodies activity against potential tumor antigenic peptides involved in graft-versus-RCC effect.
Secondary Objectives:
- To study the patient characteristics of metastatic RCC patients who undergo NST and those who do not undergo NST.
- To compare the incidence of Day-100 treatment-related mortality in FM group and FC group.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Cell Cancer |
Drug: Fludarabine Drug: Melphalan Drug: Cyclophosphamide Procedure: Stem Cell Transplant |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Adaptive Randomization of Fludarabine-Melphalan Versus Fludarabine-Cyclophosphamide Conditioning Regimen in Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using HLA-Matched Related Donor for Metastatic Renal Cell Carcinoma |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Drug Information available for:
Cyclophosphamide
Melphalan
Melphalan hydrochloride
Fludarabine
Fludarabine phosphate
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Survival Rate [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]Number of participants surviving at 4 years compared to total participants, 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. Evaulation after 1, 2, 3, 6, 9, & 12 months, then every 4 months for 4 years.
| Enrollment: | 40 |
| Study Start Date: | January 2004 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fludarabine + Cyclophosphamide with ASCT
ASCT=Allogeneic Hematopoietic Stem Cell Transplantation
|
Drug: Fludarabine
25 mg/m^2 intravenous (IV) daily for 5 Days
Drug: Cyclophosphamide
60 mg/kg IV Daily for 2 Days
Procedure: Stem Cell Transplant
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using HLA-Matched Related Donor
Other Names:
|
|
Experimental: Fludarabine + Melphalan with ASCT
ASCT=Allogeneic Hematopoietic Stem Cell Transplantation
|
Drug: Fludarabine
25 mg/m^2 intravenous (IV) daily for 5 Days
Drug: Melphalan
70 mg/m^2 IV Daily for 2 Days
Procedure: Stem Cell Transplant
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using HLA-Matched Related Donor
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429026
Locations
| United States, Texas | |
| U.T. M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Naoto Ueno, MD, PhD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00429026 History of Changes |
| Other Study ID Numbers: | 2003-0364 |
| Study First Received: | January 29, 2007 |
| Results First Received: | February 26, 2009 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Kidney Cancer Renal Cell Cancer Stem Cell Transplant Cyclophosphamide |
Fludarabine Melphalan NST |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Cyclophosphamide Melphalan Fludarabine monophosphate |
Fludarabine Vidarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 23, 2013