Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005637
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2000-05-02
Brief Title:
Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Extended Low Dose Temozolomide SCH 52365 Temodar R and Carmustine BCNU in the Treatment of Malignant Gliomas After Radiation Therapy
Status:
COMPLETED
Status Verified Date:
2003-03
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 Combining more than one chemotherapy drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy following radiation therapy in treating patients who have malignant glioma
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy following radiation therapy in treating patients who have malignant glioma
Detailed Description:
OBJECTIVES
Determine the safety and efficacy of extended low-dose temozolomide when combined with carmustine after radiotherapy in patients with malignant glioma
Determine the maximum tolerated dose of this combination in this patient population
Determine time to progression as measured from baseline gadolinium-enhanced magnetic resonance imaging in patients treated with this regimen
OUTLINE This is a dose-escalation study of temozolomide
Patients receive oral temozolomide once daily on days 1-28 and carmustine IV over 1-3 hours beginning within 72 hours after starting temozolomide Courses repeat every 8 weeks for up to 1 year in the absence of unacceptable toxicity or disease progression
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 6 patients experience dose-limiting toxicity
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for this study within 1-2 years
Determine the safety and efficacy of extended low-dose temozolomide when combined with carmustine after radiotherapy in patients with malignant glioma
Determine the maximum tolerated dose of this combination in this patient population
Determine time to progression as measured from baseline gadolinium-enhanced magnetic resonance imaging in patients treated with this regimen
OUTLINE This is a dose-escalation study of temozolomide
Patients receive oral temozolomide once daily on days 1-28 and carmustine IV over 1-3 hours beginning within 72 hours after starting temozolomide Courses repeat every 8 weeks for up to 1 year in the absence of unacceptable toxicity or disease progression
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 6 patients experience dose-limiting toxicity
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for this study within 1-2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1765 | None | None | None |
| MSKCC-99114 | None | None | None |