Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Recurrent Kidney Cancer

• Status: Withdrawn
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells. Sometimes the transplanted cells can be rejected by the body's tissues. Mycophenolate mofetil, tacrolimus, and donor white blood cells may prevent this from happening.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have metastatic or recurrent kidney cancer.

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

Details

• Lead Sponsor: Fox Chase Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Fludarabine; Fludarabine phosphate; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus; Thalidomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma (RCC)

• Histology demonstrates major clear cell component

• Metastatic (stage IV) or recurrent disease

• Prior debulking nephrectomy required

• Disease not amenable to complete surgical resection

• Must have HLA-identical donor

• Matched related sibling donors must have 6/6 serologic HLA A, B, and DR match with molecular confirmation at DRB1

• A 5/6 serologic mismatch with one antigen mismatch at locus A or B (not DR) with molecular confirmation at locus A, B, and DRB1 allowed

• Matched unrelated donors must have a minimum of 8 out of 10 molecular matches at loci A, B, C, DRB1, and DQB1

• No brain metastases

• Negative MRI required

PATIENT CHARACTERISTICS:

Age:

• 18 to 65

Performance status:

• Karnofsky 80-100% OR

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin less than 2 times upper limit of normal (ULN)

• ALT/AST less than 2 times ULN

• Alkaline phosphatase less than 2 times ULN

• Hepatitis A, B, and C negative

Renal:

• Creatinine clearance greater than 50 mL/min

• Calcium less than 10.5 mg/dL (bisphosphonates allowed)

Cardiovascular:

• LVEF no less than 10% below lower limit of normal

Pulmonary:

• FEV_1 and DLCO greater than 50%

Other:

• HIV negative

• No active bacterial, fungal, or viral (including cytomegalovirus) infections

• No intolerance or allergy to tacrolimus, mycophenolate mofetil, or fludarabine

• No intolerance to 200 cGy of total body irradiation

• No other serious comorbid disease, neurologic condition, or psychosocial condition that would preclude study follow-up

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception for at least 1 month before, during, and for at least 3 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Prior interleukin-2 allowed

• Prior interferon alfa allowed

Chemotherapy:

• Prior chemotherapy allowed

• No other concurrent chemotherapy for RCC

Endocrine therapy:

• No concurrent corticosteroids for other comorbid disease

Radiotherapy:

• No prior extensive radiotherapy to marrow microenvironment greater than 20% of total marrow mass

• No prior radiotherapy that has reached tissue tolerance for heart, lung, liver, kidney, or spinal cord

Surgery:

• See Disease Characteristics

Other:

• No other concurrent therapy for RCC

• No concurrent enrollment on another investigational protocol for treatment of RCC

• No other concurrent immunosuppressive medications

• No other concurrent investigational drugs