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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

Primary Purpose

Kidney Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cyclosporine
fludarabine phosphate
mycophenolate mofetil
allogeneic bone marrow transplantation
peripheral blood stem cell transplantation
radiation therapy
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage IV renal cell cancer, clear cell renal cell carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • OHSU Knight Cancer Institute

Outcomes

Primary Outcome Measures

Response rate (complete and partial response) at 6 and 12 months after transplantation

Secondary Outcome Measures

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

Full Information

First Posted
October 20, 2005
Last Updated
May 24, 2012
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00243009
Brief Title
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
Official Title
Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Metastatic Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Terminated
Why Stopped
Due to a lack of a referal base, study was terminated.
Study Start Date
June 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
recurrent renal cell cancer, stage IV renal cell cancer, clear cell renal cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cyclosporine
Intervention Type
Drug
Intervention Name(s)
fludarabine phosphate
Intervention Type
Drug
Intervention Name(s)
mycophenolate mofetil
Intervention Type
Procedure
Intervention Name(s)
allogeneic bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Response rate (complete and partial response) at 6 and 12 months after transplantation
Secondary Outcome Measure Information:
Title
Severity of graft-vs-host-disease by Glucksburg Scale after transplantation for up to 5 years
Title
Incidence of graft rejection based on donor chimerims after transplantation for up to 5 years
Title
Non-relapse mortality as assessed by Kaplan-Meier after transplantation for up to 5 years
Title
Disease-free survival as assessed by Kaplan-Meier after transplantation for up to 5 years
Title
Overall survival as assessed by Kaplan-Meier after transplantation for up to 5 years
Title
Toxicity as measured by CTC AE v 3.0 100 days after transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon M. Hayes-Lattin, MD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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