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

• Status: Terminated
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclosporine; Cyclosporins; Fludarabine; Fludarabine phosphate; Mycophenolate mofetil; Mycophenolic Acid

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