Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262730
Status:
COMPLETED
Last Update Posted:
2019-06-12
First Post:
2005-12-06
Brief Title:
Radiation Therapy and Temozolomide Followed by Temozolomide and Poly ICLC in Treating Patients With Newly Diagnosed GBM
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 Radiation Plus Temozolomide Followed by Adjuvant Temozolomide and Poly-ICLC in Patients With Newly Diagnosed Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2019-05
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 Radiation therapy uses high-energy x-rays to kill tumor cells Drugs used in chemotherapy such as temozolomide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Biological therapies such as poly ICLC may stimulate the immune system in different ways and stop tumor cells from growing Giving poly ICLC after radiation therapy and temozolomide may stop any remaining tumor cells from growing
PURPOSE This phase II trial is studying how well giving radiation therapy together with temozolomide followed by temozolomide and poly ICLC works in treating patients with newly diagnosed glioblastoma multiforme
PURPOSE This phase II trial is studying how well giving radiation therapy together with temozolomide followed by temozolomide and poly ICLC works in treating patients with newly diagnosed glioblastoma multiforme
Detailed Description:
OBJECTIVES
Primary
Evaluate the safety and efficacy of radiation plus low-dose temozolomide followed by adjuvant temozolomide and intramuscular poly ICLC for adult patients with newly diagnosed glioblastoma multiforme
Secondary
Estimate the frequency of toxicity associated with this treatment regimen
OUTLINE This is an open-label multicenter study
Induction chemoradiotherapy Patients undergo radiotherapy once daily 5 days a week for 6 weeks During the same 6 weeks patients also receive oral temozolomide once daily Four weeks later patients are evaluated for disease progression Patients with progressive disease are removed from the study Patients with no progressive disease proceed to maintenance therapy
Maintenance therapy Patients receive oral temozolomide once daily on days 1-5 week 1 Patients also receive poly ICLC intramuscularly three times a week in weeks 2-8 Courses repeat every 9 weeks in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed every 2 months for survival
PROJECTED ACCRUAL A total of 96 patients will be accrued for this study
Primary
Evaluate the safety and efficacy of radiation plus low-dose temozolomide followed by adjuvant temozolomide and intramuscular poly ICLC for adult patients with newly diagnosed glioblastoma multiforme
Secondary
Estimate the frequency of toxicity associated with this treatment regimen
OUTLINE This is an open-label multicenter study
Induction chemoradiotherapy Patients undergo radiotherapy once daily 5 days a week for 6 weeks During the same 6 weeks patients also receive oral temozolomide once daily Four weeks later patients are evaluated for disease progression Patients with progressive disease are removed from the study Patients with no progressive disease proceed to maintenance therapy
Maintenance therapy Patients receive oral temozolomide once daily on days 1-5 week 1 Patients also receive poly ICLC intramuscularly three times a week in weeks 2-8 Courses repeat every 9 weeks in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed every 2 months for survival
PROJECTED ACCRUAL A total of 96 patients will be accrued for this study
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 |
|---|---|---|---|
| NA_00001963 | OTHER | JHM IRB | httpsreporternihgovquickSearchU01CA062475 |
| U01CA062475 | NIH | None | None |
| NABTT-0501 CDR0000454915 | None | None | None |