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Trial record 11 of 544 for:    stem cell kidney

Fludarabine and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Metastatic Kidney Cancer That Cannot Be Removed By Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00243009
Recruitment Status : Terminated (Due to a lack of a referal base, study was terminated.)
First Posted : October 21, 2005
Last Update Posted : May 28, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
OHSU Knight Cancer Institute

Brief Summary:

RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving fludarabine together with total-body irradiation works in treating patients who are undergoing a donor stem cell transplant for metastatic kidney cancer that cannot be removed by surgery.

Condition or disease Intervention/treatment Phase
Kidney Cancer Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy Phase 2

Detailed Description:


  • Determine the efficacy of nonmyeloablative conditioning comprising fludarabine and total-body irradiation followed by allogeneic hematopoietic stem cell transplantation, in terms of 6-month and 12-month response rate, in patients with unresectable metastatic renal cell carcinoma.


  • Nonmyeloablative conditioning regimen: Patients receive fludarabine IV on days -4 to -2 and total-body irradiation (TBI) on day 0.
  • Allogeneic hematopoietic stem cell transplantation (AHSCT): After TBI, patients undergo AHSCT on day 0.
  • Immunosuppression: Patients receive oral cyclosporine twice daily on days -3 to 56 followed by a taper until day 81. Patients also receive oral mycophenolate mofetil twice daily on days 0-27 (if patient has a related donor) OR three times daily on days 0-29 and then twice daily on days 30-149 followed by additional tapering until day 180 (if patient has an unrelated donor).

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Metastatic Renal Cell Carcinoma
Study Start Date : June 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Primary Outcome Measures :
  1. Response rate (complete and partial response) at 6 and 12 months after transplantation

Secondary Outcome Measures :
  1. Severity of graft-vs-host-disease by Glucksburg Scale after transplantation for up to 5 years
  2. Incidence of graft rejection based on donor chimerims after transplantation for up to 5 years
  3. Non-relapse mortality as assessed by Kaplan-Meier after transplantation for up to 5 years
  4. Disease-free survival as assessed by Kaplan-Meier after transplantation for up to 5 years
  5. Overall survival as assessed by Kaplan-Meier after transplantation for up to 5 years
  6. Toxicity as measured by CTC AE v 3.0 100 days after transplantation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed renal cell carcinoma, including 1 of the following subtypes:

    • Clear cell
    • Papillary
    • Medullary
  • Metastatic disease
  • Not amenable to curative surgery
  • No CNS metastases


Performance status

  • Karnofsky 70-100%

Life expectancy

  • More than 6 months


  • Not specified


  • Bilirubin < 2 times upper limit of normal (ULN)
  • AST or ALT < 4 times ULN


  • Creatinine clearance > 50 mL/min


  • LVEF > 35%
  • No symptomatic congestive heart failure


  • DLCO > 40% of predicted OR
  • Total lung capacity or FEV_1 > 30% of predicted


Biologic therapy

  • More than 30 days since prior biologic therapy


  • More than 30 days since prior chemotherapy


  • More than 30 days since prior radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00243009

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United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
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Study Chair: Brandon M. Hayes-Lattin, MD OHSU Knight Cancer Institute

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Responsible Party: OHSU Knight Cancer Institute Identifier: NCT00243009    
Other Study ID Numbers: CDR0000447207
OHSU-ONC-03077-L ( Other Identifier: OHSU Knight Cancer Institute )
OHSU-1282 ( Other Identifier: OHSU IRB )
First Posted: October 21, 2005    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: June 2010
Keywords provided by OHSU Knight Cancer Institute:
recurrent renal cell cancer
stage IV renal cell cancer
clear cell renal cell carcinoma
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Mycophenolic Acid
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Infective Agents
Enzyme Inhibitors
Antifungal Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors