Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058123
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2003-04-07
Brief Title:
Poly-ICLC in Treating Patients With Recurrent or Progressive 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 Poly ICLC in Patients With Recurrent Anaplastic Glioma
Status:
COMPLETED
Status Verified Date:
2018-07
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 Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing
PURPOSE This phase II trial is studying how poly-ICLC works in treating patients with recurrent progressive or relapsed anaplastic glioma
PURPOSE This phase II trial is studying how poly-ICLC works in treating patients with recurrent progressive or relapsed anaplastic glioma
Detailed Description:
OBJECTIVES
Determine the objective response rate in patients with recurrent or progressive anaplastic glioma treated with poly ICLC
Determine the efficacy of this drug in terms of 6-month progression-free survival in these patients
Determine the safety profile of this drug in these patients
Determine the survival of patients treated with this drug
Determine the tumor response rate in patients treated with this drug
Determine the biological effects of this drug in these patients
OUTLINE This is a multicenter study
Patients receive poly ICLC intramuscularly 3 times a week for 4 weeks Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 22-46 patients will be accrued for this study
Determine the objective response rate in patients with recurrent or progressive anaplastic glioma treated with poly ICLC
Determine the efficacy of this drug in terms of 6-month progression-free survival in these patients
Determine the safety profile of this drug in these patients
Determine the survival of patients treated with this drug
Determine the tumor response rate in patients treated with this drug
Determine the biological effects of this drug in these patients
OUTLINE This is a multicenter study
Patients receive poly ICLC intramuscularly 3 times a week for 4 weeks Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 22-46 patients will be accrued for this study
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 |
|---|---|---|---|
| NABTC-0106 | US NIH GrantContract | None | httpsreporternihgovquickSearchU01CA062399 |
| U01CA062399 | NIH | None | None |