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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006968
Recruitment Status : Completed
First Posted : June 27, 2003
Last Update Posted : January 8, 2013
National Cancer Institute (NCI)
Information provided by:
Jonsson Comprehensive Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Kidney Cancer Biological: filgrastim Drug: cyclosporine Drug: pentostatin Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Phase 1 Phase 2

Detailed Description:


  • 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.

  • 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Primary Purpose: Treatment
Official Title: Non-Myeloablative Chemotherapy Followed By Related Allogeneic Stem Cell Rescue In Patients With Advanced Renal Cell Carcinoma
Study Start Date : September 2000
Actual Primary Completion Date : September 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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



  • Over 18

Performance status:

  • ECOG 0-1

Life expectancy:

  • 3 to 6 months


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


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


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


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


  • DLCO at least 40% of predicted


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


Biologic therapy:

  • No more than 1 prior biologic therapy


  • No more than 6 months of prior chemotherapy

Endocrine therapy:

  • At least 1 year since prior steroids


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006968

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United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1678
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
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Study Chair: Gary J. Schiller, MD Jonsson Comprehensive Cancer Center

Layout table for additonal information Identifier: NCT00006968    
Other Study ID Numbers: CDR0000068349
First Posted: June 27, 2003    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013
Keywords provided by Jonsson Comprehensive Cancer Center:
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antineoplastic Agents
Adenosine Deaminase Inhibitors