Full Text View
Tabular View
No Study Results Posted
Related Studies
Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer
This study has been completed.
Study NCT00006968   Information provided by National Cancer Institute (NCI)
First Received: December 6, 2000   Last Updated: February 6, 2009   History of Changes

December 6, 2000
February 6, 2009
September 2000
 
 
 
Complete list of historical versions of study NCT00006968 on ClinicalTrials.gov Archive Site
 
 
 
Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer
Non-Myeloablative Chemotherapy Followed By Related Allogeneic Stem Cell Rescue In Patients With Advanced Renal Cell Carcinoma

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.

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.

  • 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.

Phase I, Phase II
Interventional
Treatment
Kidney Cancer
  • Biological: filgrastim
  • Drug: cyclosporine
  • Drug: pentostatin
  • Procedure: allogeneic bone marrow transplantation
  • Procedure: peripheral blood stem cell transplantation
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006968
 
CDR0000068349, UCLA-0001032, SUPERGEN-UCLA-000103201, NCI-G00-1879
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Gary J. Schiller, MD Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
February 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP