Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068510
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2003-09-10
Brief Title:
Vaccine Therapy in Treating Patients With Malignant Glioma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Phase I Dose Escalation Study of Autologous Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Malignant Gliomas
Status:
COMPLETED
Status Verified Date:
2013-08
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 Vaccines made from a persons white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with malignant glioma
PURPOSE This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with malignant glioma
Detailed Description:
OBJECTIVES
Determine the dose-limiting toxicity and maximum tolerated dose of autologous tumor lysate-pulsed dendritic cells in patients with malignant gliomas
Determine survival tumor progression and cellular immune response in patients treated with this regimen
OUTLINE This is a dose-escalation study
Patients undergo leukapheresis for the collection of peripheral blood mononuclear cells PBMC Autologous dendritic cells DC are prepared from autologous PBMC exposed to sargramostim GM-CSF and interleukin-4 and pulsed with autologous tumor lysate Patients receive autologous tumor lysate-pulsed DC intradermally on days 0 14 and 28 in the absence of unacceptable toxicity
Cohorts of 6-12 patients receive escalating doses of autologous tumor lysate-pulsed DC 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
Patients are followed every 2 months for 2 years
PROJECTED ACCRUAL A total of 3-18 patients will be accrued for this study within 9-18 months
Determine the dose-limiting toxicity and maximum tolerated dose of autologous tumor lysate-pulsed dendritic cells in patients with malignant gliomas
Determine survival tumor progression and cellular immune response in patients treated with this regimen
OUTLINE This is a dose-escalation study
Patients undergo leukapheresis for the collection of peripheral blood mononuclear cells PBMC Autologous dendritic cells DC are prepared from autologous PBMC exposed to sargramostim GM-CSF and interleukin-4 and pulsed with autologous tumor lysate Patients receive autologous tumor lysate-pulsed DC intradermally on days 0 14 and 28 in the absence of unacceptable toxicity
Cohorts of 6-12 patients receive escalating doses of autologous tumor lysate-pulsed DC 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
Patients are followed every 2 months for 2 years
PROJECTED ACCRUAL A total of 3-18 patients will be accrued for this study within 9-18 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 |
|---|---|---|---|
| UCLA-0304053 | None | None | None |