Trials / Withdrawn
WithdrawnNCT00458744
Talotrexin in Treating Young Patients With Recurrent Solid Tumors or Leukemia That is Recurrent or Does Not Respond to Treatment
A Phase I Study Of Talotrexin (PT-523) In Children And Adolescents With Recurrent Solid Tumors Or Recurrent/Refractory Leukemias
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Children's Oncology Group · Network
- Sex
- All
- Age
- 1 Year – 21 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Brain and Central Nervous System Tumors
- Leukemia
- Lymphoma
- Unspecified Childhood Solid Tumor, Protocol Specific
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | talotrexin | |
| PROCEDURE | chemotherapy |
Timeline
- Start date
- 2007-02-01
- Primary completion
- 2008-07-01
- First posted
- 2007-04-11
- Last updated
- 2014-08-08
Source: ClinicalTrials.gov record NCT00458744. Inclusion in this directory is not an endorsement.