Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Completed Over 18 NCI, Pharmaceutical / Industry UCLA-0001032 SUPERGEN-UCLA-000103201, NCI-G00-1879, NCT00006968

Objectives

1. 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.
2. Determine the hematologic and non-hematologic toxic effects of this regimen in these patients.
3. Determine the incidence and severity of graft-versus-host disease in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed advanced renal cell cancer



• No bone metastases



• No CNS disease



• Must have an allogeneic donor available

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

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

Expected Enrollment

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

Outline

This is a dose-escalation study of pentostatin.

• Phase I: 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.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Gary Schiller, MD, Protocol chair		Ph: 310-825-5513; 888-798-0719 Email: garyjs@ucla.edu

Registry Information
Official Title		Non-Myeloablative Chemotherapy Followed By Related Allogeneic Stem Cell Rescue In Patients With Advanced Renal Cell Carcinoma
Trial Start Date		2000-09-01
Registered in ClinicalTrials.gov		NCT00006968
Date Submitted to PDQ		2000-11-01
Information Last Verified		2005-02-11
NCI Grant/Contract Number		CA16042

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