Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107185
Status:
COMPLETED
Last Update Posted:
2020-08-05
First Post:
2005-04-05
Brief Title:
Vaccine Therapy in Treating Young Patients Who Are Undergoing Surgery for 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 in Pediatric Patients
Status:
COMPLETED
Status Verified Date:
2012-08
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 and tumor cells may help the body build an effective immune response to kill tumor cells Giving vaccine therapy after surgery may be a more effective treatment for malignant glioma
PURPOSE This phase I trial is studying the side effects and best dose of vaccine therapy in treating young patients who are undergoing surgery for malignant glioma
PURPOSE This phase I trial is studying the side effects and best dose of vaccine therapy in treating young patients who are undergoing surgery for malignant glioma
Detailed Description:
OBJECTIVES
Primary
Determine the dose-limiting toxicity of adjuvant vaccination with autologous tumor lysate-pulsed dendritic cells after surgical resection in pediatric patients with malignant glioma
Determine the maximum tolerated dose of this vaccine in these patients
Secondary
Determine preliminarily the survival of patients treated with this vaccine
Determine preliminarily the time to tumor progression in patients treated with this vaccine
Determine cellular immune response in patients treated with this vaccine
Determine age-dependent differences in response to this vaccine in terms of immunocompetence in these patients
OUTLINE This is a dose-escalation study
Patients undergo surgical resection to obtain tumor tissue for production of tumor lysate Patients then undergo leukapheresis to obtain peripheral blood mononuclear cells PBMC for generation of dendritic cells DC DC are pulsed with tumor lysate to produce an autologous dendritic cell vaccine Approximately 10-30 days after leukapheresis patients receive vaccination with autologous tumor lysate-pulsed dendritic cells intradermally on days 0 14 and 28 in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of vaccine 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
After completion of study treatment patients are followed at 2 weeks and then every 2 months for 1 year
PROJECTED ACCRUAL A total of 3-18 patients will be accrued for this study within 2-45 years
Primary
Determine the dose-limiting toxicity of adjuvant vaccination with autologous tumor lysate-pulsed dendritic cells after surgical resection in pediatric patients with malignant glioma
Determine the maximum tolerated dose of this vaccine in these patients
Secondary
Determine preliminarily the survival of patients treated with this vaccine
Determine preliminarily the time to tumor progression in patients treated with this vaccine
Determine cellular immune response in patients treated with this vaccine
Determine age-dependent differences in response to this vaccine in terms of immunocompetence in these patients
OUTLINE This is a dose-escalation study
Patients undergo surgical resection to obtain tumor tissue for production of tumor lysate Patients then undergo leukapheresis to obtain peripheral blood mononuclear cells PBMC for generation of dendritic cells DC DC are pulsed with tumor lysate to produce an autologous dendritic cell vaccine Approximately 10-30 days after leukapheresis patients receive vaccination with autologous tumor lysate-pulsed dendritic cells intradermally on days 0 14 and 28 in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of vaccine 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
After completion of study treatment patients are followed at 2 weeks and then every 2 months for 1 year
PROJECTED ACCRUAL A total of 3-18 patients will be accrued for this study within 2-45 years
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-0410044-01 | None | None | None |