Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138216
Status:
COMPLETED
Last Update Posted:
2023-10-02
First Post:
2005-08-29
Brief Title:
Temozolomide Vincristine and Irinotecan in Treating Young Patients With Refractory Solid Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase I Study of Temozolomide Oral Irinotecan and Vincristine for Children With Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as temozolomide vincristine and irinotecan work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of irinotecan when given together with temozolomide and vincristine in treating young patients with refractory solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of irinotecan when given together with temozolomide and vincristine in treating young patients with refractory solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose and recommended phase II dose of irinotecan when administered with temozolomide and vincristine in young patients with refractory solid tumors including brain tumors
Determine the toxic effects of this regimen in these patients
Compare the toxic effects of this regimen in patients with low- vs high-risk UGT1A1 genotypes
Determine the pharmacokinetics of irinotecan in these patients
Secondary
Determine preliminarily the antitumor activity of this regimen in these patients
Correlate UGT1A1 UGT1A7 UGT1A9 and BCRP genotypes with the pharmacokinetics and pharmacodynamics of irinotecan and its metabolites in these patients
OUTLINE This is a multicenter dose-escalation study of irinotecan Patients are stratified according to UGT1A1 genotype high-risk 77 or 67 genotype AND bilirubin 06 mgdL vs low-risk absence of high-risk criteria if a high-risk patient experiences a dose-limiting toxicity DLT
Patients receive oral temozolomide on days 1-5 and oral irinotecan on days 1-5 and 8-12 Patients also receive vincristine IV over 1 minute 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 irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT
After completion of study treatment patients are followed for 1 month and then annually thereafter
PROJECTED ACCRUAL A total of 3-36 patients will be accrued for this study within 18 months
Primary
Determine the maximum tolerated dose and recommended phase II dose of irinotecan when administered with temozolomide and vincristine in young patients with refractory solid tumors including brain tumors
Determine the toxic effects of this regimen in these patients
Compare the toxic effects of this regimen in patients with low- vs high-risk UGT1A1 genotypes
Determine the pharmacokinetics of irinotecan in these patients
Secondary
Determine preliminarily the antitumor activity of this regimen in these patients
Correlate UGT1A1 UGT1A7 UGT1A9 and BCRP genotypes with the pharmacokinetics and pharmacodynamics of irinotecan and its metabolites in these patients
OUTLINE This is a multicenter dose-escalation study of irinotecan Patients are stratified according to UGT1A1 genotype high-risk 77 or 67 genotype AND bilirubin 06 mgdL vs low-risk absence of high-risk criteria if a high-risk patient experiences a dose-limiting toxicity DLT
Patients receive oral temozolomide on days 1-5 and oral irinotecan on days 1-5 and 8-12 Patients also receive vincristine IV over 1 minute 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 irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT
After completion of study treatment patients are followed for 1 month and then annually thereafter
PROJECTED ACCRUAL A total of 3-36 patients will be accrued for this study within 18 months
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 |
|---|---|---|---|
| COG-ADVL0414 | OTHER | None | None |
| CDR0000440069 | OTHER | ClinicalTrialsgov | None |