Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-12 @ 10:46 PM
Study NCT ID:
NCT01957956
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2013-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Pilot Clinical Trial of Allogeneic Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccination in Newly Diagnosed Glioblastoma
Status:
COMPLETED
Status Verified Date:
2023-11
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:
This pilot clinical trial studies vaccine therapy and temozolomide in treating patients with newly diagnosed glioblastoma. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy and temozolomide may be an effective treatment for glioblastoma.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the safety and feasibility of adjuvant temozolomide plus combined allogeneic tumor primary tumor culture lysate / autologous dendritic cell (DC) vaccination (malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine) in newly diagnosed glioblastoma patients following surgical debulking and external beam radiation therapy with concurrent temozolomide.
SECONDARY OBJECTIVES:
I. To document survival and progression-free survival in newly diagnosed glioblastoma patients receiving adjuvant temozolomide plus allogeneic tumor primary tumor culture lysate / autologous DC vaccination to historical data.
TERTIARY OBJECTIVES:
I. Determine the ability of allogeneic tumor primary tumor culture lysate / autologous DC vaccine to generate multiple tumor-associated antigens (TAA)-specific immune responses in newly diagnosed glioblastoma multiforme (GBM) patients.
II. Assess the relationship between ability tumor induce TAA-specific immune responses and evidence of immunosuppression (peripheral blood immunophenotyping by flow cytometry) following allogeneic tumor primary tumor culture lysate / autologous DC vaccine in newly diagnosed GBM patients.
III. Assess the relationship between efficacy endpoints (survival, progression-free survival, tumor response) and tumor-associated antigen immune response following combined autologous or allogeneic tumor lysate / DC vaccination and adjuvant temozolomide.
IV. Assess the relationship between efficacy endpoints (survival, progression-free survival, tumor response) and evidence of immunosuppression at baseline and over time with combined autologous or allogeneic tumor lysate / DC vaccination and adjuvant temozolomide.
OUTLINE:
COURSE 1: Patients receive temozolomide orally (PO) daily on days 1-5.
COURSES 2-3: Patients receive temozolomide PO daily on days 1-5 and malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine intradermally (ID) on days 1, 3, and 5.
COURSES 4-6: Patients receive temozolomide PO daily on days 1-5 and malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on day 1.
COURSES 7-12: Patients receive malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on day 1.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
I. To determine the safety and feasibility of adjuvant temozolomide plus combined allogeneic tumor primary tumor culture lysate / autologous dendritic cell (DC) vaccination (malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine) in newly diagnosed glioblastoma patients following surgical debulking and external beam radiation therapy with concurrent temozolomide.
SECONDARY OBJECTIVES:
I. To document survival and progression-free survival in newly diagnosed glioblastoma patients receiving adjuvant temozolomide plus allogeneic tumor primary tumor culture lysate / autologous DC vaccination to historical data.
TERTIARY OBJECTIVES:
I. Determine the ability of allogeneic tumor primary tumor culture lysate / autologous DC vaccine to generate multiple tumor-associated antigens (TAA)-specific immune responses in newly diagnosed glioblastoma multiforme (GBM) patients.
II. Assess the relationship between ability tumor induce TAA-specific immune responses and evidence of immunosuppression (peripheral blood immunophenotyping by flow cytometry) following allogeneic tumor primary tumor culture lysate / autologous DC vaccine in newly diagnosed GBM patients.
III. Assess the relationship between efficacy endpoints (survival, progression-free survival, tumor response) and tumor-associated antigen immune response following combined autologous or allogeneic tumor lysate / DC vaccination and adjuvant temozolomide.
IV. Assess the relationship between efficacy endpoints (survival, progression-free survival, tumor response) and evidence of immunosuppression at baseline and over time with combined autologous or allogeneic tumor lysate / DC vaccination and adjuvant temozolomide.
OUTLINE:
COURSE 1: Patients receive temozolomide orally (PO) daily on days 1-5.
COURSES 2-3: Patients receive temozolomide PO daily on days 1-5 and malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine intradermally (ID) on days 1, 3, and 5.
COURSES 4-6: Patients receive temozolomide PO daily on days 1-5 and malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on day 1.
COURSES 7-12: Patients receive malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on day 1.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2013-01743 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |