Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00362570
Status:
COMPLETED
Last Update Posted:
2017-11-30
First Post:
2006-08-08
Brief Title:
Temozolomide in Patients With Newly Diagnosed Anaplastic Oligodendroglioma and Mixed Oligoastrocytoma
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Trial of Continuous Dose Temozolomide in Patients With Newly Diagnosed Anaplastic Oligodendroglioma and Mixed Oligoastrocytoma
Status:
COMPLETED
Status Verified Date:
2017-11
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
Standard therapy for anaplastic oligodendrogliomas and mixed oligoastrocytomas includes radiation and chemotherapy However due to the potential long-term central nervous system toxicity from radiation researchers speculate that it may be better to reserve radiation therapy for progressive disease In addition some patients with anaplastic oligodendroglioma and mixed oligoastrocytoma have unusually chemosensitive tumors Previous research indicates that brain tumor patients with a deletion of the 1p chromosome have a higher response to the chemotherapy drug temozolomide
Standard therapy for anaplastic oligodendrogliomas and mixed oligoastrocytomas includes radiation and chemotherapy However due to the potential long-term central nervous system toxicity from radiation researchers speculate that it may be better to reserve radiation therapy for progressive disease In addition some patients with anaplastic oligodendroglioma and mixed oligoastrocytoma have unusually chemosensitive tumors Previous research indicates that brain tumor patients with a deletion of the 1p chromosome have a higher response to the chemotherapy drug temozolomide
Detailed Description:
Temozolomide has demonstrated clinical antitumor efficacy against malignant gliomas at both relapse and initial diagnosis This drug appears to have less adverse effects compared to other drugs used against brain tumors Therefore temozolomide is often better tolerated in brain tumor patients compared to other brain tumor drugs The current study builds on previous research to test the efficacy of chemotherapy alone in patients with anaplastic oligodendroglioma and mixed oligoastrocytoma
Purpose
This study will evaluate response rate or how the disease size changes in patients and survival without disease growth in patients with anaplastic oligodendroglioma and mixed oligoastrocytoma treated with temozolomide Quality of life will also be assessed in this patient population treated with the study regimen
Treatment
Study participants will be treated with the drug temozolomide This drug will be administered in oral pills Temozolomide will be taken for seven consecutive days followed by seven days without the drug This treatment schedule of seven days on temozolomide followed by seven days off will continue throughout the study Several tests and exams will be given to closely monitor patients MRI scans will be performed every 8 weeks to measure disease response Temozolomide as a study drug will be given to study participants for a total of 8 week four cycles However treatments will be discontinued due to disease growth or unacceptable adverse events
Purpose
This study will evaluate response rate or how the disease size changes in patients and survival without disease growth in patients with anaplastic oligodendroglioma and mixed oligoastrocytoma treated with temozolomide Quality of life will also be assessed in this patient population treated with the study regimen
Treatment
Study participants will be treated with the drug temozolomide This drug will be administered in oral pills Temozolomide will be taken for seven consecutive days followed by seven days without the drug This treatment schedule of seven days on temozolomide followed by seven days off will continue throughout the study Several tests and exams will be given to closely monitor patients MRI scans will be performed every 8 weeks to measure disease response Temozolomide as a study drug will be given to study participants for a total of 8 week four cycles However treatments will be discontinued due to disease growth or unacceptable adverse events
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