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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00006968
Other study ID # CDR0000068349
Secondary ID UCLA-0001032SUPE
Status Completed
Phase Phase 1/Phase 2
First received December 6, 2000
Last updated January 7, 2013
Start date September 2000

Study information

Verified date January 2013
Source Jonsson Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date
Est. primary completion date September 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
filgrastim

Drug:
cyclosporine

pentostatin

Procedure:
allogeneic bone marrow transplantation

peripheral blood stem cell transplantation


Locations

Country Name City State
United States Jonsson Comprehensive Cancer Center, UCLA Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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