Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005813
Status:
COMPLETED
Last Update Posted:
2011-10-27
First Post:
2000-06-02
Brief Title:
Bispecific Antibody Plus White Blood Cells in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
A Phase I Trial of Intratumoral Bispecific Antibody and Activated Monocytes in Patients With Recurrent or Refractory Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2011-10
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 Bispecific antibodies plus white blood cells may be able to locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase I trial to study the effectiveness of combining bispecific antibodies with white blood cells in treating patients who have recurrent or refractory glioblastoma multiforme
PURPOSE Phase I trial to study the effectiveness of combining bispecific antibodies with white blood cells in treating patients who have recurrent or refractory glioblastoma multiforme
Detailed Description:
OBJECTIVES
Assess the safety and tolerability of bispecific antibody MDX447 and activated monocytes in patients with recurrent or refractory glioblastoma multiforme
Determine the response time to tumor progression and overall survival of these patients treated with this regimen
OUTLINE This is a dose escalation study
Patients undergo maximal surgical debulking of the tumor at the time of reservoir placement Within 2-4 weeks after surgery patients receive one treatment of intratumoral bispecific antibody MDX447 and activated monocytes Stable or responding patients may receive a second treatment 1 month later
Cohorts of 1 or 3 patients receive escalating doses of bispecific antibody MDX447 and activated monocytes until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities
PROJECTED ACCRUAL A total of 13 patients will be accrued for this study
Assess the safety and tolerability of bispecific antibody MDX447 and activated monocytes in patients with recurrent or refractory glioblastoma multiforme
Determine the response time to tumor progression and overall survival of these patients treated with this regimen
OUTLINE This is a dose escalation study
Patients undergo maximal surgical debulking of the tumor at the time of reservoir placement Within 2-4 weeks after surgery patients receive one treatment of intratumoral bispecific antibody MDX447 and activated monocytes Stable or responding patients may receive a second treatment 1 month later
Cohorts of 1 or 3 patients receive escalating doses of bispecific antibody MDX447 and activated monocytes until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities
PROJECTED ACCRUAL A total of 13 patients will be accrued for 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 |
|---|---|---|---|
| NCI-G00-1783 | OTHER_GRANT | NCI | httpsreporternihgovquickSearchP30CA023108 |
| P30CA023108 | NIH | None | None |