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 Leukemia Lymphoma Unspecified Childhood Solid Tumor, Protocol Specific||Drug: talotrexin Procedure: chemotherapy||Phase 1|
|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
- Antitumor activity
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458744
|Study Chair:||James Croop, MD, PhD||Riley's Children Cancer Center at Riley Hospital for Children|
|Study Chair:||Sultan Ahmed Pradhan, MD||Tata Memorial Hospital|