A Phase I Study Of Talotrexin (PT-523) In Children And Adolescents With Recurrent Solid Tumors Or Recurrent/Refractory Leukemias
OBJECTIVES:
Primary
- Estimate the maximum tolerated dose (MTD) and recommended phase II dose of talotrexin
in younger patients with recurrent solid tumors or recurrent or refractory leukemia.
- Determine the toxicity of this drug in these patients.
Secondary
- Determine the antitumor activity of this drug in these patients.
- Assess the tolerability of the defined MTD of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
diagnosis (solid tumor vs leukemia).
- Stratum 1 (recurrent solid tumor): Patients receive talotrexin IV over 10 minutes on
days 1 and 8. Treatment repeats every 21 days for up to 17 courses in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of talotrexin 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 (DLT).
- Stratum 2 (recurrent or refractory leukemia): A cohort of 3-6 patients with leukemia
receive treatment as in stratum 1 at the MTD determined in stratum 1. If 2 or 3 or 2 of
6 patients experience a DLT at the solid tumor MTD, accrual is stopped.
After completion of study treatment, patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Maximum tolerated dose of talotrexin
Yes
James Croop, MD, PhD
Study Chair
Riley's Children Cancer Center at Riley Hospital for Children
Unspecified
CDR0000538359
NCT00458744
February 2007
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