Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006024
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2000-07-05
Brief Title:
Temozolomide Plus Lomustine Followed by Radiation Therapy in Treating Patients With High-Grade Malignant Glioma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase I Study of Temozolomide and CCNU in Pediatric Patients With Newly Diagnosed Incompletely Resected Non-Brainstem High-Grade Gliomas
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 use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of temozolomide plus lomustine followed by radiation therapy in treating patients who have high-grade malignant glioma
PURPOSE Phase I trial to study the effectiveness of temozolomide plus lomustine followed by radiation therapy in treating patients who have high-grade malignant glioma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of temozolomide when administered with lomustine in patients with high-grade malignant gliomas
Determine the dose-limiting toxic effects of this regimen in these patients
Evaluate the feasibility of radiotherapy after this treatment regimen in this patient population
Evaluate the radiographic responses in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of temozolomide
Patients receive oral temozolomide on days 1-5 and oral lomustine on day 1 Treatment continues every 28 days if blood counts have recovered for 2 courses in the absence of disease progression or unacceptable toxicity Patients then undergo radiotherapy on days 1-5 weekly for 6 weeks Patients continue the same chemotherapy regimen for up to 6 more courses beginning 4 weeks after completion of radiotherapy
Cohorts of 3-6 patients receive escalating doses of temozolomide 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
Patients are followed for survival
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for this study
Determine the maximum tolerated dose of temozolomide when administered with lomustine in patients with high-grade malignant gliomas
Determine the dose-limiting toxic effects of this regimen in these patients
Evaluate the feasibility of radiotherapy after this treatment regimen in this patient population
Evaluate the radiographic responses in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of temozolomide
Patients receive oral temozolomide on days 1-5 and oral lomustine on day 1 Treatment continues every 28 days if blood counts have recovered for 2 courses in the absence of disease progression or unacceptable toxicity Patients then undergo radiotherapy on days 1-5 weekly for 6 weeks Patients continue the same chemotherapy regimen for up to 6 more courses beginning 4 weeks after completion of radiotherapy
Cohorts of 3-6 patients receive escalating doses of temozolomide 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
Patients are followed for survival
PROJECTED ACCRUAL A total of 3-30 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 |
|---|---|---|---|
| COG-ADVL0011 | OTHER | None | None |
| CCG-ADVL0011 | OTHER | None | None |
| CCG-A0993 | OTHER | None | None |
| CDR0000068036 | OTHER | Clinical Trialsgov | None |