Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052715
Status:
TERMINATED
Last Update Posted:
2018-07-18
First Post:
2003-01-24
Brief Title:
Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase II Trial Of Poly-ICLC For Glioblastoma
Status:
TERMINATED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
prematurely discontinued after results of the EORTC phase-3 study defined the SOC for newly diagnosed GMB pts as RT plus concomitant and adjuvant TMZ
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Poly-ICLC
Brief Summary:
RATIONALE Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing Radiation therapy uses high-energy x-rays to damage tumor cells Combining biological therapy with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining poly-ICLC with radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme
PURPOSE Phase II trial to study the effectiveness of combining poly-ICLC with radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme
Detailed Description:
OBJECTIVES
Determine the efficacy of poly ICLC and radiotherapy in terms of total survival from date of diagnosis in patients with newly diagnosed glioblastoma multiforme
Determine the safety and toxicity profile of this regimen in these patients
Determine the 12-month survival rate in patients treated with this regimen
Assess progression-free survival at 6 months and median progression-free survival from date of diagnosis of patients treated with this regimen
Assess response in patients treated with this regimen
Assess changes in neurological status in patients treated with this regimen
OUTLINE This is a multicenter study
Within 1-4 weeks after surgery patients receive poly ICLC intramuscularly 3 times weekly on days 1 3 and 5 Treatment continues in the absence of disease progression or unacceptable toxicity
One week after the initiation of poly ICLC patients undergo external beam radiotherapy once daily 5 days a week for 6 weeks
Patients are followed monthly for 1 year and then every 3 months thereafter
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 2 years
Determine the efficacy of poly ICLC and radiotherapy in terms of total survival from date of diagnosis in patients with newly diagnosed glioblastoma multiforme
Determine the safety and toxicity profile of this regimen in these patients
Determine the 12-month survival rate in patients treated with this regimen
Assess progression-free survival at 6 months and median progression-free survival from date of diagnosis of patients treated with this regimen
Assess response in patients treated with this regimen
Assess changes in neurological status in patients treated with this regimen
OUTLINE This is a multicenter study
Within 1-4 weeks after surgery patients receive poly ICLC intramuscularly 3 times weekly on days 1 3 and 5 Treatment continues in the absence of disease progression or unacceptable toxicity
One week after the initiation of poly ICLC patients undergo external beam radiotherapy once daily 5 days a week for 6 weeks
Patients are followed monthly for 1 year and then every 3 months thereafter
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| NCI-2012-02506 | REGISTRY | CTRP Clinical Trials Reporting System | None |
| CDR0000258685 | REGISTRY | None | None |