Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003176
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
1999-11-01
Brief Title:
Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Phase II Trial of Temozolomide and BCNU for Anaplastic Gliomas
Status:
COMPLETED
Status Verified Date:
2018-06
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 drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of temozolomide and carmustine in treating patients with anaplastic glioma
PURPOSE Phase II trial to study the effectiveness of temozolomide and carmustine in treating patients with anaplastic glioma
Detailed Description:
OBJECTIVES I Evaluate the activity measured in terms of progression free survival of carmustine plus temozolomide in recurrent glioblastoma II Estimate the response rate of recurrent glioblastomas to this combination III Estimate the response rate of newly diagnosed anaplastic astrocytomas and mixed anaplastic glioma to this combination IV Evaluate the qualitative and quantitative toxicities of this combination in patients with anaplastic gliomas
OUTLINE This is a nonrandomized study Patients are stratified by disease recurrent glioblastoma vs anaplastic astrocytoma or mixed anaplastic glioma Patients receive carmustine intravenously on day 1 two hours prior to temozolomide Temozolomide is administered orally on day 1 Cycles repeat every 42 days Treatment for patients with recurrent glioblastoma may continue for 8 cycles in the absence of disease progression or unacceptable toxicity If there is no disease progression after 8 cycles treatment may continue further at the investigators discretion Patients with anaplastic astrocytoma or mixed anaplastic glioma continue for 4 cycles of treatment Patients are followed periodically at the investigators discretion at least twice in the first 4 months and then until death
PROJECTED ACCRUAL A minimum of 17 patients and a maximum of 37 patients will be accrued in the recurrent glioblastoma stratum and 45 patients will be accrued into the anaplastic astrocytoma and mixed anaplastic glioma stratum
OUTLINE This is a nonrandomized study Patients are stratified by disease recurrent glioblastoma vs anaplastic astrocytoma or mixed anaplastic glioma Patients receive carmustine intravenously on day 1 two hours prior to temozolomide Temozolomide is administered orally on day 1 Cycles repeat every 42 days Treatment for patients with recurrent glioblastoma may continue for 8 cycles in the absence of disease progression or unacceptable toxicity If there is no disease progression after 8 cycles treatment may continue further at the investigators discretion Patients with anaplastic astrocytoma or mixed anaplastic glioma continue for 4 cycles of treatment Patients are followed periodically at the investigators discretion at least twice in the first 4 months and then until death
PROJECTED ACCRUAL A minimum of 17 patients and a maximum of 37 patients will be accrued in the recurrent glioblastoma stratum and 45 patients will be accrued into the anaplastic astrocytoma and mixed anaplastic glioma stratum
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| NCI-T96-0082 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065986 | REGISTRY | None | None |