Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003564
Status:
WITHDRAWN
Last Update Posted:
2012-02-22
First Post:
1999-11-01
Brief Title:
Procarbazine and Isotretinoin in Treating Patients With Recurrent Primary Malignant Gliomas
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Randomized Evaluation of 13-Cis-Retinoic Acid cRA Plus Procarbazine Versus Procarbazine Alone in the Treatment of Patients With Recurrent Primary Malignant Gliomas
Status:
WITHDRAWN
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study withdrawn
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 It is not yet known whether giving procarbazine alone or with isotretinoin is more effective for recurrent primary malignant glioma
PURPOSE Randomized phase III trial to compare the effectiveness of procarbazine alone or with isotretinoin in treating patients with recurrent primary malignant gliomas
PURPOSE Randomized phase III trial to compare the effectiveness of procarbazine alone or with isotretinoin in treating patients with recurrent primary malignant gliomas
Detailed Description:
OBJECTIVES I Determine whether the combination of isotretinoin and procarbazine can improve time to progression and survival compared to procarbazine alone in patients with recurrent malignant gliomas II Document the toxicity of these two regimens in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to receive procarbazine alone or in combination with isotretinoin Arm I Patients receive oral procarbazine once daily on days 1-14 every 28 days Oral isotretinoin is administered every 12 hours on days 15-28 every 28 days Patient receive 6 courses of combined therapy then continue with oral isotretinoin alone on days 15-28 of each 28 day course until disease progression or unacceptable toxicity Arm II Patients receive procarbazine by mouth once daily on days 1-14 followed by 2 weeks of rest Patients receive a total of 6 courses of treatment in the absence of disease progression and unacceptable toxicity Patients are followed until death
PROJECTED ACCRUAL This study will accrue a total of 194 patients 97 per treatment group
OUTLINE This is a randomized multicenter study Patients are randomized to receive procarbazine alone or in combination with isotretinoin Arm I Patients receive oral procarbazine once daily on days 1-14 every 28 days Oral isotretinoin is administered every 12 hours on days 15-28 every 28 days Patient receive 6 courses of combined therapy then continue with oral isotretinoin alone on days 15-28 of each 28 day course until disease progression or unacceptable toxicity Arm II Patients receive procarbazine by mouth once daily on days 1-14 followed by 2 weeks of rest Patients receive a total of 6 courses of treatment in the absence of disease progression and unacceptable toxicity Patients are followed until death
PROJECTED ACCRUAL This study will accrue a total of 194 patients 97 per treatment group
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 |
|---|---|---|---|
| CDR0000066630 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| MDA-DM-97050 | OTHER | None | None |
| NCI-T97-0078 | None | None | None |