Lymphoma Clinical Trial
Official title:
High Dose Carboplatin Combined With Oral VP-16 In The Treatment Of Pediatric CNS Malignancies
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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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