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

NCT ID: NCT00243009

Last Updated: 2012-05-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2006-04-30

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.

Conditions

Kidney Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

cyclosporine

Intervention Type: DRUG

fludarabine phosphate

Intervention Type: DRUG

mycophenolate mofetil

Intervention Type: DRUG

allogeneic bone marrow transplantation

Intervention Type: PROCEDURE

peripheral blood stem cell transplantation

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brandon M. Hayes-Lattin, MD

Role: STUDY_CHAIR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

Other Identifiers

OHSU-ONC-03077-L

Identifier Type: OTHER

Identifier Source: secondary_id

OHSU-1282

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000447207

Identifier Type: -

Identifier Source: org_study_id