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Non-Myeloablative Chemotherapy Followed By Related Allogeneic Stem Cell Rescue In Patients With Advanced Renal Cell Carcinoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

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Trial Information

Non-Myeloablative Chemotherapy Followed By Related Allogeneic Stem Cell Rescue In Patients With Advanced Renal Cell Carcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Gary J. Schiller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068349

NCT ID:

NCT00006968

Start Date:

September 2000

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781