Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002965
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
1999-11-01
Brief Title:
Interferon Alfa in Treating Patients With Recurrent Unresectable Meningiomas and Malignant Meningiomas
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study to Evaluate the Efficacy of Recombinant Interferon-Alpha in the Treatment of Recurrent Unresectable Meningiomas and Malignant Meningiomas
Status:
COMPLETED
Status Verified Date:
2023-12
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 Interferon alfa may interfere with the growth of cancer cells
PURPOSE Phase II trial to study the effectiveness of interferon alfa in treating patients with recurrent unresectable meningiomas and malignant meningiomas
PURPOSE Phase II trial to study the effectiveness of interferon alfa in treating patients with recurrent unresectable meningiomas and malignant meningiomas
Detailed Description:
OBJECTIVES
Evaluate the efficacy of recombinant interferon alpha IFN alpha as a single agent in the treatment of recurrent unresectable meningiomas and malignant meningiomas
Determine the nature and extent of central nervous system CNS toxicities associated with the use of alpha interferon in current doses and schedules
OUTLINE This is a two arm randomized study The first arm includes all histologically benign meningiomas The second arm includes all other pathologies
All patients receive INF alpha as a subcutaneous injection Monday through Friday for 8 weeks Treatment continues without interruption as long as there is no tumor recurrence or progression and toxicity is acceptable
Treatment continues without dose adjustment for the first 8 weeks as long as there are no toxic effects of grade III or greater Dosage for subsequent courses is one dose level below the dose that produced toxicity of grade III or greater
PROJECTED ACCRUAL 20 patients will be entered per year into each arm
Evaluate the efficacy of recombinant interferon alpha IFN alpha as a single agent in the treatment of recurrent unresectable meningiomas and malignant meningiomas
Determine the nature and extent of central nervous system CNS toxicities associated with the use of alpha interferon in current doses and schedules
OUTLINE This is a two arm randomized study The first arm includes all histologically benign meningiomas The second arm includes all other pathologies
All patients receive INF alpha as a subcutaneous injection Monday through Friday for 8 weeks Treatment continues without interruption as long as there is no tumor recurrence or progression and toxicity is acceptable
Treatment continues without dose adjustment for the first 8 weeks as long as there are no toxic effects of grade III or greater Dosage for subsequent courses is one dose level below the dose that produced toxicity of grade III or greater
PROJECTED ACCRUAL 20 patients will be entered per year into each arm
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 |
|---|---|---|---|
| P30CA016672 | NIH | None | None |
| MDA-DM-96296 | OTHER | None | None |
| NCI-G97-1206 | None | None | None |
| CDR0000065463 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |