Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004073
Status:
COMPLETED
Last Update Posted:
2012-05-03
First Post:
1999-12-10
Brief Title:
Suramin Plus 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 Study of Suramin and Concurrent Radiation Therapy in Newly Diagnosed Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2012-05
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 Suramin may stop the growth of glioblastoma multiforme by stopping blood flow to the tumor Radiation therapy uses high-energy x-rays to damage tumor cells Combining suramin with radiation therapy may be a more effective treatment for glioblastoma multiforme
PURPOSE Phase II trial to study the effectiveness of suramin plus radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme
PURPOSE Phase II trial to study the effectiveness of suramin plus radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme
Detailed Description:
OBJECTIVES I Assess the toxicity of suramin administered prior to and concurrent with radiotherapy in patients with newly diagnosed high grade glioblastoma multiforme II Evaluate this regimen in terms of survival in this patient population
OUTLINE Patients receive suramin IV over 2 hours for initial dose and over 1 hour for subsequent doses daily for 5 days on week 1 Patients receive concurrent radiotherapy daily with suramin IV over 1 hour twice weekly on weeks 2-7 Patients with stable or responsive disease receive a second course of suramin twice weekly on weeks 20-24 Treatment continues in the absence of disease progression or unacceptable toxicity Patients are followed every 2 months until disease progression or start of new therapy and then monthly for survival
PROJECTED ACCRUAL A total of 54 patients will be accrued for this study over 15 years
OUTLINE Patients receive suramin IV over 2 hours for initial dose and over 1 hour for subsequent doses daily for 5 days on week 1 Patients receive concurrent radiotherapy daily with suramin IV over 1 hour twice weekly on weeks 2-7 Patients with stable or responsive disease receive a second course of suramin twice weekly on weeks 20-24 Treatment continues in the absence of disease progression or unacceptable toxicity Patients are followed every 2 months until disease progression or start of new therapy and then monthly for survival
PROJECTED ACCRUAL A total of 54 patients will be accrued for this study over 15 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 |
|---|---|---|---|
| U01CA062475 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| NABTT-9808 | None | None | None |
| JHOC-NABTT-9808 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |