Peripheral Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer

• Status: Unknown status
• Trial end date: 0000-00-00
• Target enrollment: 80
• Participant gender: Both

Summary

RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, before a donor peripheral blood stem cell transplant helps stop the growth of tumor cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining tumor cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine with or without mycophenolate mofetil or methotrexate after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well peripheral stem cell transplant works in treating patients with metastatic kidney cancer.

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

Details

• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Antilymphocyte Serum; Cyclophosphamide; Cyclosporine; Cyclosporins; Fludarabine; Fludarabine phosphate; Methotrexate; Mycophenolate mofetil; Mycophenolic Acid
• Last Updated: 2009-06-23

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven metastatic renal cell carcinoma not amenable to complete surgical resection and progressive despite immunotherapy

• Bidimensionally evaluable clinically or radiographically

• HLA 6/6 or 5/6 matched family donor available

• No CNS metastases

PATIENT CHARACTERISTICS:

Age:

• 18 to 80

Performance status:

• ECOG 0 or 1

Life expectancy:

• At least 3 months

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 4 mg/dL

• Transaminases no greater than 3 times upper limit of normal

Renal:

• Creatinine no greater than 2.5 mg/dL

• No malignancy-associated hypercalcemia (< 2.5 mmol/L)

Cardiovascular:

• Left ventricular ejection fraction greater than 40%

Pulmonary:

• DLCO greater than 65% of predicted

Other:

• Not pregnant

• HIV negative

• No major organ dysfunction that would preclude transplantation

• No other malignancies except basal cell or squamous cell skin cancer

• No psychiatric disorder or mental deficiency that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• At least 1 month since prior treatment for renal cell carcinoma