Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer - Full Text View

Sponsor:	Jonsson Comprehensive Cancer Center
Collaborator:	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:	Primary Purpose: 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 Lenograstim Granulocyte colony-stimulating factor

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

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

Additional relevant MeSH terms:

Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Cyclosporins
Cyclosporine
Pentostatin

Lenograstim
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antineoplastic Agents
Adenosine Deaminase Inhibitors
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on February 09, 2012