High Dose Carboplatin Combined With Oral VP-16 In The Treatment Of Pediatric CNS Malignancies
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Barbara Jean Bambach, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|St. Louis Children's Hospital||Saint Louis, Missouri 63110|