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

PURPOSE: Phase I/II trial to study the effectiveness of pentostatin followed by peripheral stem cell transplantation in treating patients who have advanced kidney cancer.

Condition	Treatment or Intervention	Phase
stage III renal cell cancer Stage IV Renal Cell Cancer recurrent renal cell cancer	Drug: cyclosporine  Drug: filgrastim  Drug: pentostatin  Procedure: allogeneic bone marrow transplantation  Procedure: biological response modifier therapy  Procedure: bone marrow ablation with stem cell support  Procedure: bone marrow transplantation  Procedure: chemotherapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy  Procedure: graft versus host disease prophylaxis/therapy  Procedure: peripheral blood stem cell transplantation  Procedure: supportive care/therapy	Phase I Phase II

Further Study Details: 

OBJECTIVES:

• Determine the duration and efficiency of hematopoietic and immunologic engraftment in patients with advanced renal cell carcinoma treated with pentostatin followed by related allogeneic stem cell transplantation.
• Determine the hematologic and non-hematologic toxic effects of this regimen in these patients.
• Determine the incidence and severity of graft-versus-host disease in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of pentostatin.

• Patients receive pentostatin IV on days -7, -5, and -3 followed by allogeneic stem cell transplantation on day 0. Beginning on day 1, patients receive filgrastim (G-CSF) IV over 1 hour or subcutaneously daily until blood counts recover. As graft-versus-host disease prophylaxis, patients receive cyclosporine IV continuously until stem cell engraftment and then orally with gradual tapering. Cohorts of 3 to 6 patients receive escalating doses of pentostatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity.
• Phase II: Patients receive treatment as in phase I at the MTD for pentostatin. Patients are followed weekly for 60 days and then monthly for 10 months.

PROJECTED ACCRUAL: A total of 24 patients (12 per phase) will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed advanced renal cell cancer
• No bone metastases
• No CNS disease
• Must have an allogeneic donor available

PATIENT CHARACTERISTICS: Age:

• Over 18

Performance status:

• ECOG 0-1

Life expectancy:

• 3 to 6 months

Hematopoietic:

• Hemoglobin at least 10 g/dL
• Complete blood count normal

Hepatic:

• Bilirubin no greater than 3 times upper limit of normal (ULN)
• Transaminases no greater than 4 times ULN
• No evidence of portal hypertension

Renal:

• Creatinine no greater than 2.0 mg/dL
• No uncontrolled hypercalcemia

Cardiovascular:

• No New York Heart Association class 3 or 4 heart disease

Pulmonary:

• DLCO at least 40% of predicted

Other:

• No severe functional neurological impairment
• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

• No more than 1 prior biologic therapy

Chemotherapy:

• No more than 6 months of prior chemotherapy

Endocrine therapy:

• At least 1 year since prior steroids

Radiotherapy:

• Not specified

Surgery:

• Not specified

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1678,  United States

Study chairs or principal investigators

Gary John Schiller, MD,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000068349; UCLA-0001032; SUPERGEN-UCLA-000103201; NCI-G00-1879; NCT00006968
Record last reviewed:  February 2005
Last Updated:  February 24, 2005
Record first received:  December 6, 2000
ClinicalTrials.gov Identifier:  NCT00006968
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08