A Phase I Trial of the Combination of Oxaliplatin (NSC 266046, IND 57004), Ifosfamide, and Etoposide in Recurrent or Refractory Pediatric Solid Tumors and Lymphomas
I. Determine the maximum tolerated dose of oxaliplatin and etoposide in pediatric patients
with recurrent or refractory solid tumors or lymphoma.
II. Determine the dose-limiting toxic effects of this regimen in these patients.
I. Determine the pharmacokinetic profile of this regimen in these patients. II. Correlate
the extent of oxaliplatin and etoposide exposure with toxic effects and therapeutic effects
of this regimen in these patients.
III. Determine, preliminarily, the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oxaliplatin IV over 2 hours on day 1 and etoposide IV over 1 hour on days
1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and etoposide 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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD of the combination of oxaliplatin and etoposide assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
St. Jude Children's Research Hospital
United States: Food and Drug Administration
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