Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer

• Status: Completed
• Trial end date: 2016-08-17
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

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

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

Details

• Lead Sponsor: UNICANCER
• Treatments: Cyclophosphamide; Cyclosporine; Cyclosporins; Fludarabine; Fludarabine phosphate

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic renal cell carcinoma

• No sarcomatoid, pure papillary, or Bellini renal cell cancer

• Measurable and/or evaluable disease

• Disease progression after at least 1 immunotherapy regimen for metastatic disease

• Localized metastases allowed provided the following are true:

• At least 3 months since prior treatment for metastases

• Not considered likely to influence outcome of transplantation

• No brain metastases unless treated surgically or radiologically and MRI normal

• Sufficiently healthy, HLA-compatible family member must be available as donor for patients undergoing stem cell transplantation

PATIENT CHARACTERISTICS:

Age

• 18 to 65

Performance status

• ECOG 0-1

Life expectancy

• More than 6 months

Hematopoietic

• Platelet count at least 100,000/mm^3

Hepatic

• Transaminases less than 1.5 times upper limit of normal (ULN)*

• Bilirubin less than 1.5 times ULN* NOTE: *Unless due to Gilbert's disease

Renal

• No renal insufficiency

• Calcium less than 10.4 mg/dL

• Creatinine clearance greater than 50 mL/min

Cardiovascular

• Ejection fraction greater than 50%

Pulmonary

• No DLCO that would preclude fludarabine or busulfan therapy

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No physical obstacle to receiving study treatment

• No known autoimmune disease

• No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix

• No uncontrolled bacterial, viral, or fungal infection

• No prior or concurrent psychiatric disease

• HIV negative

• HTLV1 negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• No tolerance to fludarabine and busulfan

Endocrine therapy

• No concurrent corticosteroids

Radiotherapy

• Not specified

Surgery

• Not specified