Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030108
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2002-01-30
Brief Title:
Ixabepilone in Treating Young Patients With Solid Tumors or Leukemia That Havent Responded to Therapy
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Trial and Pharmacokinetic Study of BMS-247550 NSC 710428 Ixabepilone an Epothilone B Analog in Pediatric Patients With Refractory Solid Tumors and Leukemias
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase I trial is studying the side effects and best dose of ixabepilone in treating young patients with relapsed or refractory solid tumors or leukemia
PURPOSE This phase I trial is studying the side effects and best dose of ixabepilone in treating young patients with relapsed or refractory solid tumors or leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose MTD and dose-limiting toxicity DLT of ixabepilone in young patients with refractory solid tumors closed to accrual as of 1042007 or relapsed or refractory leukemia
Determine the toxicity spectrum of this drug in these patients
Determine the plasma pharmacokinetics of this drug in these patients
Determine the pharmacodynamics of this drug in these patients
Assess the nerve growth factor levels before and after the initiation of this drug as a potential surrogate marker for the development of peripheral neuropathy in these patients
Secondary
Determine the response of patients treated with this drug
Compare the tolerability toxicity profile MTD DLT pharmacokinetics and pharmacodynamics of this drug in young patients treated on this study vs adults with solid tumors closed to accrual as of 1042007 treated on the ongoing Medicine Branch NCI phase I study
Assess the safety and tolerability of ixabepilone at the solid tumor MTD expanded leukemia cohort
Evaluate the plasma pharmacokinetics of in young patients with refractory or relapsed leukemia
Evaluate the extent of tubulin polymerization in leukemic blasts at baseline after treatment with ixabepilone ex-vivo
Compare the effects of tubulin polymerization in leukemic blasts with ixabepilone versus paclitaxel ex-vivo with an without the presence of a potent P-glycoprotein inhibitor
Evaluate the activity known drug transporters in drug-resistant leukemias in leukemic blasts
OUTLINE This is a multicenter dose-escalation study
Patients receive ixabepilone IV over 1 hour on days 1-5 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of ixabepilone until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity Intrapatient dose escalation to one dose level above the enrollment dose level is allowed in patients who have stable or responding disease or are experiencing other benefits from therapy eg decrease in tumor-related pain symptoms and who have no grade 2 or greater non-hematologic toxicity and no grade 3 or greater hematologic toxicity Additional patients are treated at the MTD Patients treated at the MTD may not undergo intrapatient dose escalation
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study within 1-2 years
Primary
Determine the maximum tolerated dose MTD and dose-limiting toxicity DLT of ixabepilone in young patients with refractory solid tumors closed to accrual as of 1042007 or relapsed or refractory leukemia
Determine the toxicity spectrum of this drug in these patients
Determine the plasma pharmacokinetics of this drug in these patients
Determine the pharmacodynamics of this drug in these patients
Assess the nerve growth factor levels before and after the initiation of this drug as a potential surrogate marker for the development of peripheral neuropathy in these patients
Secondary
Determine the response of patients treated with this drug
Compare the tolerability toxicity profile MTD DLT pharmacokinetics and pharmacodynamics of this drug in young patients treated on this study vs adults with solid tumors closed to accrual as of 1042007 treated on the ongoing Medicine Branch NCI phase I study
Assess the safety and tolerability of ixabepilone at the solid tumor MTD expanded leukemia cohort
Evaluate the plasma pharmacokinetics of in young patients with refractory or relapsed leukemia
Evaluate the extent of tubulin polymerization in leukemic blasts at baseline after treatment with ixabepilone ex-vivo
Compare the effects of tubulin polymerization in leukemic blasts with ixabepilone versus paclitaxel ex-vivo with an without the presence of a potent P-glycoprotein inhibitor
Evaluate the activity known drug transporters in drug-resistant leukemias in leukemic blasts
OUTLINE This is a multicenter dose-escalation study
Patients receive ixabepilone IV over 1 hour on days 1-5 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of ixabepilone until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity Intrapatient dose escalation to one dose level above the enrollment dose level is allowed in patients who have stable or responding disease or are experiencing other benefits from therapy eg decrease in tumor-related pain symptoms and who have no grade 2 or greater non-hematologic toxicity and no grade 3 or greater hematologic toxicity Additional patients are treated at the MTD Patients treated at the MTD may not undergo intrapatient dose escalation
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study within 1-2 years
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 |
|---|---|---|---|
| CDR0000069133 | None | None | None |
| 02-C-0031 | None | None | None |
| NCI-5425 | None | None | None |