Talotrexin in Treating Young Patients With Recurrent Solid Tumors or Leukemia That is Recurrent or Does Not Respond to Treatment
RATIONALE: Drugs used in chemotherapy, such as talotrexin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of talotrexin in treating young patients with recurrent solid tumors or leukemia that is recurrent or does not respond to treatment.
Brain and Central Nervous System Tumors
Unspecified Childhood Solid Tumor, Protocol Specific
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study Of Talotrexin (PT-523) In Children And Adolescents With Recurrent Solid Tumors Or Recurrent/Refractory Leukemias|
- Maximum tolerated dose of talotrexin [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
- Antitumor activity [ Designated as safety issue: No ]
- Tolerability [ Designated as safety issue: Yes ]
|Study Start Date:||February 2007|
|Estimated Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|Study Chair:||James Croop, MD, PhD||Riley's Children Cancer Center at Riley Hospital for Children|
|Investigator:||Sultan Ahmed Pradhan, MD, FACS, FRCS||Tata Memorial Hospital|