Clinical trial NCT00006968: Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer
Official title: Non-Myeloablative Chemotherapy Followed By Related Allogeneic Stem Cell Rescue In Patients With Advanced Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Kidney Cancer
Keywords: stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-06-27
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Gary J. Schiller, MD
role: STUDY_CHAIR
References: