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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00053118
Other study ID # CDR0000269284
Secondary ID RPCI-DS-00-03
Status Completed
Phase Phase 1
First received January 27, 2003
Last updated February 25, 2011
Start date March 2002
Est. completion date July 2004

Study information

Verified date February 2011
Source Roswell Park Cancer Institute
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
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 peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with peripheral stem cell transplantation in treating children who have central nervous system cancer.


Description:

OBJECTIVES:

- Determine the feasibility of administering an outpatient protocol comprising high-dose carboplatin with autologous stem cell support and etoposide in pediatric patients with primary central nervous system malignancies.

- Determine the maximum tolerated dose of carboplatin when administered in this regimen in these patients.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is dose-escalation study of carboplatin.

Patients receive filgrastim (G-CSF) IV once daily for 6 days followed by a maximum of 5 apheresis sessions. If the target number of peripheral blood stem cells is not achieved, some patients receive G-CSF and undergo apheresis as above after a 2-week rest.

At least 3 days after completion of G-CSF, patients receive high-dose carboplatin IV over 1 hour on day 1, stem cell reinfusion on day 3, G-CSF subcutaneously on days 4-18 and 43-61, and oral etoposide 3 times daily on days 21-42. Treatment continues for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed monthly for 1 year and then annually thereafter.

PROJECTED ACCRUAL: A total of 3-15 patients will be accrued for this study.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date July 2004
Est. primary completion date July 2004
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility DISEASE CHARACTERISTICS:

- Histologically confirmed primary central nervous system malignancy

- Recurrent, persistent, or progressive disease after at least 1 prior first-line treatment regimen

PATIENT CHARACTERISTICS:

Age

- 18 and under at initial diagnosis

Performance status

- ECOG 0-2

Life expectancy

- At least 8 weeks

Hematopoietic

- Absolute neutrophil count greater than 750/mm^3

- WBC greater than 2,500/mm^3

- Platelet count greater than 100,000/mm^3

- No underlying myelodysplasia, stem cell disorder, or other inherent hematologic synthetic defect

Hepatic

- Liver function tests less than 2 times normal OR

- Absence of active hepatitis by liver biopsy

- Bilirubin less than 1.5 mg/dL

Renal

- Glomerular filtration rate greater than 60 mL/min by radionucleotide assay

Cardiovascular

- Ejection fraction at least 45%

Pulmonary

- Clinically normal pulmonary function (patients 5 years of age and under)

- FEV_1 and FVC at least 50% (patients over 5 years of age) OR

- Arterial blood gas normal and DLCO greater than 50%

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No mucositis or mucosal infection

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- At least 3 weeks since prior systemic cytotoxic chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- At least 6 months since prior radiotherapy to the pelvis or spine

Surgery

- Not specified

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
filgrastim
IV
Drug:
carboplatin
IV
etoposide
IV
Procedure:
bone marrow ablation with stem cell support
IV
peripheral blood stem cell transplantation
IV

Locations

Country Name City State
United States Roswell Park Cancer Institute Buffalo New York
United States University of Texas - MD Anderson Cancer Center Houston Texas
United States St. Louis Children's Hospital Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

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