Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006355
Status:
COMPLETED
Last Update Posted:
2012-05-03
First Post:
2000-10-04
Brief Title:
Pyrazoloacridine Followed by Radiation Therapy in Treating Adults With Newly Diagnosed Supratentorial 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 III Study of Pyrazoloacridine PZA in Adults With 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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining chemotherapy and radiation therapy may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of pyrazoloacridine followed by radiation therapy in treating adults who have newly diagnosed supratentorial glioblastoma multiforme
PURPOSE Phase III trial to study the effectiveness of pyrazoloacridine followed by radiation therapy in treating adults who have newly diagnosed supratentorial glioblastoma multiforme
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose toxicity and pharmacokinetics of pyrazoloacridine in adults with newly diagnosed supratentorial glioblastoma multiforme treated with pyrazoloacridine followed by radiotherapy
Determine the response rate duration of disease free survival and survival of patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to type of anticonvulsant hepatic metabolic enzyme inducers vs hepatic metabolic enzyme moderate inducers or noninducers
Patients receive pyrazoloacridine PZA IV over 3 hours on day 1 Treatment repeats every 3 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity Following completion of PZA treatment patients undergo cranial irradiation 5 days a week for 6 weeks
Cohorts of 3 patients receive escalating doses of PZA until the maximum tolerated dose MTD is determined Additional patients receive PZA at the MTD
Patients are followed monthly for survival
PROJECTED ACCRUAL A minimum of 3 patients will be accrued for phase I and a total of 18-35 patients will be accrued for phase II of this study
Determine the maximum tolerated dose toxicity and pharmacokinetics of pyrazoloacridine in adults with newly diagnosed supratentorial glioblastoma multiforme treated with pyrazoloacridine followed by radiotherapy
Determine the response rate duration of disease free survival and survival of patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to type of anticonvulsant hepatic metabolic enzyme inducers vs hepatic metabolic enzyme moderate inducers or noninducers
Patients receive pyrazoloacridine PZA IV over 3 hours on day 1 Treatment repeats every 3 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity Following completion of PZA treatment patients undergo cranial irradiation 5 days a week for 6 weeks
Cohorts of 3 patients receive escalating doses of PZA until the maximum tolerated dose MTD is determined Additional patients receive PZA at the MTD
Patients are followed monthly for survival
PROJECTED ACCRUAL A minimum of 3 patients will be accrued for phase I and a total of 18-35 patients will be accrued for phase II of 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 |
|---|---|---|---|
| JHOC-NABTT-9804 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |
| U01CA062475 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| NABTT-9804 | None | None | None |