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Conditioning Regimen in Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation

This study has been terminated.
(Slow accrual, study terminated.)
Sponsor:
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
  Purpose

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.

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:


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:
  • Stem Cell Transplant
  • ASCT
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:
  • Stem Cell Transplant
  • ASCT

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Melphalan
Alkylating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014