Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00516282
Status:
TERMINATED
Last Update Posted:
2011-08-26
First Post:
2007-08-14
Brief Title:
VNP40101M and Temozolomide in Treating Patients With Progressive or Relapsed Malignant Glioma
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase III Trial of Cloretazine VNP40101M and Temodar Temozolomide for Patients With Malignant Glioma in First Relapse or Progression
Status:
TERMINATED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The pharmaceutical collaborator filed for bankruptcy and as a result the study was unable to move into the phase II portion
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 such as temozolomide and VNP40101M work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Temozolomide may also stop the growth of tumor cells by blocking blood flow to the tumor
PURPOSE This phase III trial is studying the side effects and best dose of VNP40101M when given together with temozolomide and to see how well it works in treating patients with progressive or relapsed malignant glioma
PURPOSE This phase III trial is studying the side effects and best dose of VNP40101M when given together with temozolomide and to see how well it works in treating patients with progressive or relapsed malignant glioma
Detailed Description:
OBJECTIVES
To determine the maximum tolerated dose MTD of VNP40101M when administered with temozolomide in patients with progressive or relapsed first relapse malignant glioma Phase I
To record the toxicities of VNP40101M when administered with temozolomide Phase I and II
To measure the level of AGT expression in peripheral blood monocytes before treatment with temozolomide and just prior to the administration of VNP40101M Phase I and II
To determine MGMT methylation status as well as other methylation patterns in blood and tissue from patients treated with this regimen and correlate with outcome Phase I and II
To determine the 6- and 12-month progression-free survival rates of patients treated with this regimen Phase II
To determine overall survival of patients treated with this regimen Phase II
To determine the complete and partial response rates in patients treated with this regimen Phase II
To determine CSF penetration of VNP40101M once the MTD is reached from phase I and correlate with serumplasma pharmacokinetics Phase II
OUTLINE
Phase I Patients receive oral temozolomide on days 1-7 and VNP40101M IV over 15-30 minutes 2 hours after the last dose of temozolomide on day 7 Treatment repeats every 7 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity
Phase II Patients receive oral temozolomide and VNP40101M as in phase I VNP40101M is given at the MTD determined in phase I
In both phases patients complete the Functional Assessment of Cancer Therapy-Brain FACT-BR questionnaire on day 1 of each course
Blood is collected for in vitro isolation of mononuclear cells for analysis of O6 alkylguanine DNA alkyltransferase on days 1 and 7 of course 1 Blood plasma CSF and formalin-fixed paraffin-embedded tissue blocks are collected for gene methylation studies including MGMT at baseline and on day 1 of each course
To determine the maximum tolerated dose MTD of VNP40101M when administered with temozolomide in patients with progressive or relapsed first relapse malignant glioma Phase I
To record the toxicities of VNP40101M when administered with temozolomide Phase I and II
To measure the level of AGT expression in peripheral blood monocytes before treatment with temozolomide and just prior to the administration of VNP40101M Phase I and II
To determine MGMT methylation status as well as other methylation patterns in blood and tissue from patients treated with this regimen and correlate with outcome Phase I and II
To determine the 6- and 12-month progression-free survival rates of patients treated with this regimen Phase II
To determine overall survival of patients treated with this regimen Phase II
To determine the complete and partial response rates in patients treated with this regimen Phase II
To determine CSF penetration of VNP40101M once the MTD is reached from phase I and correlate with serumplasma pharmacokinetics Phase II
OUTLINE
Phase I Patients receive oral temozolomide on days 1-7 and VNP40101M IV over 15-30 minutes 2 hours after the last dose of temozolomide on day 7 Treatment repeats every 7 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity
Phase II Patients receive oral temozolomide and VNP40101M as in phase I VNP40101M is given at the MTD determined in phase I
In both phases patients complete the Functional Assessment of Cancer Therapy-Brain FACT-BR questionnaire on day 1 of each course
Blood is collected for in vitro isolation of mononuclear cells for analysis of O6 alkylguanine DNA alkyltransferase on days 1 and 7 of course 1 Blood plasma CSF and formalin-fixed paraffin-embedded tissue blocks are collected for gene methylation studies including MGMT at baseline and on day 1 of each course
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