Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00458744
Status:
WITHDRAWN
Last Update Posted:
2014-08-08
First Post:
2007-04-09
Brief Title:
Talotrexin in Treating Young Patients With Recurrent Solid Tumors or Leukemia That is Recurrent or Does Not Respond to Treatment
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase I Study Of Talotrexin PT-523 In Children And Adolescents With Recurrent Solid Tumors Or RecurrentRefractory Leukemias
Status:
WITHDRAWN
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study withdrawn because of toxicity reported on the adult phase 1 trial
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000538359 | OTHER | Clinical Trialsgov | None |
| COG-ADVL0613 | OTHER | None | None |