Chemotherapy and Stem Cell Transplantation in Treating Children With Central Nervous System Cancer

Sponsor

Roswell Park Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00053118

Collaborator

(none)

Enrollment

Locations

Duration (Months)

0.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors Lymphoma Neuroblastoma Retinoblastoma	Biological: filgrastim Drug: carboplatin Drug: etoposide Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

High Dose Carboplatin Combined With Oral VP-16 In The Treatment Of Pediatric CNS Malignancies

Study Start Date :

Mar 1, 2002

Actual Primary Completion Date :

Jul 1, 2004

Actual Study Completion Date :

Jul 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Louis Children's Hospital	Saint Louis	Missouri	United States	63110
2	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
3	University of Texas - MD Anderson Cancer Center	Houston	Texas	United States	77030