Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004868
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2000-03-07
Brief Title:
SU5416 in Treating Patients With Recurrent Astrocytoma or Mixed Glioma That Has Not Responded to Radiation Therapy
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Phase III Trial of SU5416 in Patients With Recurrent High Grade Astrocytomas or Mixed Gliomas
Status:
COMPLETED
Status Verified Date:
2018-06
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 SU5416 may stop the growth of astrocytoma or glioma by stopping blood flow to the tumor
PURPOSE Phase III trial to study the effectiveness of SU5416 in treating patients who have recurrent astrocytoma or mixed glioma that has not responded to previous radiation therapy
PURPOSE Phase III trial to study the effectiveness of SU5416 in treating patients who have recurrent astrocytoma or mixed glioma that has not responded to previous radiation therapy
Detailed Description:
OBJECTIVES Phase I
Determine the maximum tolerated dose of SU5416 in patients with recurrent malignant glioma who are as well as those who are not taking enzyme-inducing antiepileptic drugs
Determine the toxic effects safety profile of this drug in this patient population
Characterize the pharmacokinetics of this drug in these patients
Develop exploratory data relative to surrogate endpoints of angiogenic activity in vivo including functional imaging and in vitro assays of endothelial cell inhibition and serum angiogenic peptides
Phase II
Determine the efficacy of SU5416 in terms of 6-month progression-free survival in patients with recurrent high-grade glioma
Determine further the safety profile of the phase II dose of this drug in this patient population
Develop exploratory data relative to surrogate endpoints of angiogenic activity in vivo including functional imaging and in vitro assays of endothelial cell inhibition and serum angiogenic peptides
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs no vs yes
Patients receive SU5416 IV on days 1 and 4 weekly for 4 weeks Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of SU5416 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 Once the MTD has been determined additional patients are accrued to the phase II portion of the study These patients receive SU5416 IV as in the phase I portion at the appropriate MTD established in phase I
Patients are followed for survival
PROJECTED ACCRUAL At least 30 patients will be accrued for the phase I dose-escalation portion of this study within 10 months An additional 48 patients 32 with glioblastoma multiforme and 16 with anaplastic glioma will be accrued for the phase II portion of this study within 6-8 months
Determine the maximum tolerated dose of SU5416 in patients with recurrent malignant glioma who are as well as those who are not taking enzyme-inducing antiepileptic drugs
Determine the toxic effects safety profile of this drug in this patient population
Characterize the pharmacokinetics of this drug in these patients
Develop exploratory data relative to surrogate endpoints of angiogenic activity in vivo including functional imaging and in vitro assays of endothelial cell inhibition and serum angiogenic peptides
Phase II
Determine the efficacy of SU5416 in terms of 6-month progression-free survival in patients with recurrent high-grade glioma
Determine further the safety profile of the phase II dose of this drug in this patient population
Develop exploratory data relative to surrogate endpoints of angiogenic activity in vivo including functional imaging and in vitro assays of endothelial cell inhibition and serum angiogenic peptides
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs no vs yes
Patients receive SU5416 IV on days 1 and 4 weekly for 4 weeks Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of SU5416 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 Once the MTD has been determined additional patients are accrued to the phase II portion of the study These patients receive SU5416 IV as in the phase I portion at the appropriate MTD established in phase I
Patients are followed for survival
PROJECTED ACCRUAL At least 30 patients will be accrued for the phase I dose-escalation portion of this study within 10 months An additional 48 patients 32 with glioblastoma multiforme and 16 with anaplastic glioma will be accrued for the phase II portion of this study within 6-8 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000067527 | REGISTRY | None | None |
| MSKCC-01045 | None | None | None |
| NCI-00-C-0173 | Registry Identifier | PDQ Physician Data Query | None |