Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005976
Status:
COMPLETED
Last Update Posted:
2013-06-03
First Post:
2000-07-05
Brief Title:
Pyrazoloacridine Plus Carboplatin in Treating Patients With Recurrent Glioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Trial of Pyrazoloacridine and Carboplatin in Patients With Recurrent Glioma
Status:
COMPLETED
Status Verified Date:
2003-09
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:
Phase III trial to study the effectiveness of pyrazoloacridine plus carboplatin in treating patients who have recurrent glioma Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of pyrazoloacridine plus carboplatin in patients with recurrent glioma
II Determine the toxic effects of this treatment regimen in these patients III Determine the safety of this treatment regimen at the recommended phase II dose in patients not receiving anticonvulsants
IV Determine the efficacy of this treatment regimen in these patients V Assess the pharmacokinetics and metabolism of pyrazoloacridine in these patients
VI Assess the response rate time to progression and time to death in patients treated with this regimen
OUTLINE This is a three-part dose-escalation multicenter study Patients in study 3 are stratified according to concurrent anticonvulsants yes vs no
STUDY 1 Study 1 closed as of 032902 Patients receive carboplatin IV over 30 minutes and pyrazoloacridine IV over 3 hours on day 1 Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of carboplatin and pyrazoloacridine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
STUDY 2 Study 2 closed as of 032902 Patients receive the same treatment as given in study 1 Dose escalation is performed as in study 1 to determine the MTD in patients not receiving concurrent anticonvulsants
STUDY 3 Patients receive the same treatment as given in studies 1 and 2 without dose escalation
Patients are followed every 3 months for 1 year every 6 months for 4 years and then annually for 5 years
PROJECTED ACCRUAL
Study 1 A total of 3-21 patients will be accrued for this study within 6-20 months
Study 2 A total of 3-12 patients will be accrued for this study within 3-18 months
Study 3 A total of 12-37 patients will be accrued for this study within 15 months
I Determine the maximum tolerated dose of pyrazoloacridine plus carboplatin in patients with recurrent glioma
II Determine the toxic effects of this treatment regimen in these patients III Determine the safety of this treatment regimen at the recommended phase II dose in patients not receiving anticonvulsants
IV Determine the efficacy of this treatment regimen in these patients V Assess the pharmacokinetics and metabolism of pyrazoloacridine in these patients
VI Assess the response rate time to progression and time to death in patients treated with this regimen
OUTLINE This is a three-part dose-escalation multicenter study Patients in study 3 are stratified according to concurrent anticonvulsants yes vs no
STUDY 1 Study 1 closed as of 032902 Patients receive carboplatin IV over 30 minutes and pyrazoloacridine IV over 3 hours on day 1 Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of carboplatin and pyrazoloacridine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
STUDY 2 Study 2 closed as of 032902 Patients receive the same treatment as given in study 1 Dose escalation is performed as in study 1 to determine the MTD in patients not receiving concurrent anticonvulsants
STUDY 3 Patients receive the same treatment as given in studies 1 and 2 without dose escalation
Patients are followed every 3 months for 1 year every 6 months for 4 years and then annually for 5 years
PROJECTED ACCRUAL
Study 1 A total of 3-21 patients will be accrued for this study within 6-20 months
Study 2 A total of 3-12 patients will be accrued for this study within 3-18 months
Study 3 A total of 12-37 patients will be accrued for this study within 15 months
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 |
|---|---|---|---|
| CDR0000067963 | REGISTRY | PDQ Physician Data Query | None |
| NCCTG-987254 | None | None | None |