Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020150
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2001-07-11
Brief Title:
Temozolomide and O6-benzylguanine in Treating Children With Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial and Pharmacokinetic Study of Temozolomide and O6-Benzylguanine in Childhood Solid Tumors
Status:
COMPLETED
Status Verified Date:
2004-08
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining temozolomide and O6-benzylguanine in treating children who have solid tumors that have not responded to previous therapy
PURPOSE Phase I trial to study the effectiveness of combining temozolomide and O6-benzylguanine in treating children who have solid tumors that have not responded to previous therapy
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of temozolomide administered with a biologically active dose of O6-benzylguanine O6-BG in children with refractory solid tumors
Determine the dose-limiting toxicity and the toxicity profile of this combination in these patients
Assess the plasma pharmacokinetics of O6-BG and its active metabolite 8-oxo-O6-BG in these patients
Assess the plasma pharmacokinetics of this combination in these patients
Correlate levels of alanine-glyoxylate aminotransferase in peripheral blood mononuclear cells with the degree of hematologic toxicity of this combination in these patients
OUTLINE This is a dose-escalation study
Patients receive O6-benzylguanine O6-BG IV over 1 hour followed 30 minutes later by oral temozolomide daily for 5 days Treatment continues every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression
Sequential dose escalation of O6-BG is followed by sequential dose escalation of temozolomide Cohorts of 3-6 patients receive escalating doses of O6-BG and temozolomide until the maximum tolerated dose MTD of each is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 6 patients experience dose-limiting toxicity
Quality of life is assessed at baseline and prior to courses 1 3 6 8 and 12
PROJECTED ACCRUAL A total of 21-48 patients will be accrued for this study within 1-2 years
Determine the maximum tolerated dose of temozolomide administered with a biologically active dose of O6-benzylguanine O6-BG in children with refractory solid tumors
Determine the dose-limiting toxicity and the toxicity profile of this combination in these patients
Assess the plasma pharmacokinetics of O6-BG and its active metabolite 8-oxo-O6-BG in these patients
Assess the plasma pharmacokinetics of this combination in these patients
Correlate levels of alanine-glyoxylate aminotransferase in peripheral blood mononuclear cells with the degree of hematologic toxicity of this combination in these patients
OUTLINE This is a dose-escalation study
Patients receive O6-benzylguanine O6-BG IV over 1 hour followed 30 minutes later by oral temozolomide daily for 5 days Treatment continues every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression
Sequential dose escalation of O6-BG is followed by sequential dose escalation of temozolomide Cohorts of 3-6 patients receive escalating doses of O6-BG and temozolomide until the maximum tolerated dose MTD of each is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 6 patients experience dose-limiting toxicity
Quality of life is assessed at baseline and prior to courses 1 3 6 8 and 12
PROJECTED ACCRUAL A total of 21-48 patients will be accrued for this study within 1-2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-00-C-0105I | None | None | None |
| NCI-237 | None | None | None |