A Phase I Study Of PS-341 In Pediatric Patients With Refractory Solid Tumors
I. Determine the maximum tolerated dose of bortezomib in pediatric patients with refractory
II. Determine the dose-limiting toxicity and other toxic effects of this regimen in these
III. Preliminarily determine the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bortezomib 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. If dose-limiting toxicity in the form of
myelosuppression occurs in stratum I, dose escalation continues with patients meeting the
qualifications for stratum II.
PROJECTED ACCRUAL: Approximately 24-36 patients will be accrued for this study.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD defined as the dose at which fewer than 20% of patients experience DLT assessed using CTC version 2.0
Children's Oncology Group
United States: Food and Drug Administration
|Children's Oncology Group||Arcadia, California 91006-3776|