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

This study has been terminated.
(Due to a lack of a referal base, study was terminated.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00243009
First received: October 20, 2005
Last updated: May 24, 2012
Last verified: June 2010

October 20, 2005
May 24, 2012
June 2005
April 2006   (final data collection date for primary outcome measure)
Response rate (complete and partial response) at 6 and 12 months after transplantation [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00243009 on ClinicalTrials.gov Archive Site
  • Severity of graft-vs-host-disease by Glucksburg Scale after transplantation for up to 5 years [ Designated as safety issue: No ]
  • Incidence of graft rejection based on donor chimerims after transplantation for up to 5 years [ Designated as safety issue: No ]
  • Non-relapse mortality as assessed by Kaplan-Meier after transplantation for up to 5 years [ Designated as safety issue: No ]
  • Disease-free survival as assessed by Kaplan-Meier after transplantation for up to 5 years [ Designated as safety issue: No ]
  • Overall survival as assessed by Kaplan-Meier after transplantation for up to 5 years [ Designated as safety issue: No ]
  • Toxicity as measured by CTC AE v 3.0 100 days after transplantation [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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
Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Metastatic Renal Cell Carcinoma

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.

OBJECTIVES:

  • 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.

OUTLINE:

  • 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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Cancer
  • Drug: cyclosporine
  • Drug: fludarabine phosphate
  • Drug: mycophenolate mofetil
  • Procedure: allogeneic bone marrow transplantation
  • Procedure: peripheral blood stem cell transplantation
  • Radiation: radiation therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
April 2006
April 2006   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Performance status

  • Karnofsky 70-100%

Life expectancy

  • More than 6 months

Hematopoietic

  • Not specified

Hepatic

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

Renal

  • Creatinine clearance > 50 mL/min

Cardiovascular

  • LVEF > 35%
  • No symptomatic congestive heart failure

Pulmonary

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 30 days since prior biologic therapy

Chemotherapy

  • More than 30 days since prior chemotherapy

Radiotherapy

  • More than 30 days since prior radiotherapy
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00243009
CDR0000447207, OHSU-ONC-03077-L, OHSU-1282
Yes
OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Study Chair: Brandon M. Hayes-Lattin, MD OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP