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Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer
This study has been completed.
First Received: December 6, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006968
  Purpose

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

Study Type: Interventional
Study Design: Treatment
Official Title: Non-Myeloablative Chemotherapy Followed By Related Allogeneic Stem Cell Rescue In Patients With Advanced Renal Cell Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation Cancer Kidney Cancer
Drug Information available for: Pentostatin Cyclosporine Cyclosporin Filgrastim
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2000
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006968

Locations
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)
Investigators
Study Chair: Gary J. Schiller, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000068349, UCLA-0001032, SUPERGEN-UCLA-000103201, NCI-G00-1879
Study First Received: December 6, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00006968     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer

Study placed in the following topic categories:
Urinary Tract Neoplasm
Pentostatin
Kidney Cancer
Cyclosporine
Immunologic Factors
Urogenital Neoplasms
Urologic Neoplasms
Immunosuppressive Agents
Cyclosporins
Recurrence
 Carcinoma
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Antifungal Agents
Carcinoma, Renal Cell
Kidney Diseases
Antirheumatic Agents
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Infective Agents
Pentostatin
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Cyclosporins
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Antifungal Agents
 Therapeutic Uses
Kidney Diseases
Dermatologic Agents
Neoplasms by Histologic Type
Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Carcinoma, Renal Cell
Antirheumatic Agents
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009



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