NCT03360708

Vaccine Therapy in Treating Patients With Recurrent Glioblastoma

Pilot Clinical Trial of Allogeneic Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccination in Recurrent Glioblastoma

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot early phase I trial studies the side effects of vaccine therapy in treating patients with glioblastoma that has come back. Vaccines made from a person's white blood cells mixed with tumor proteins from another person's glioblastoma tumors may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy may work better in treating patients with glioblastoma.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety and feasibility of malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine (autologous dendritic cell \[DC\] / allogeneic glioblastoma multiforme \[GBM\] culture lysate vaccination) in glioblastoma patients at first or second recurrence. SECONDARY OBJECTIVES: I. To document survival and progression-free survival in glioblastoma patients at first or second recurrence receiving autologous DC / allogeneic GBM culture lysate vaccination and compared to historical data. TERTIARY OBJECTIVES: I. Determine the ability of autologous DC / GBM culture lysate vaccination to generate multiple tumor-associated antigen (TAA)-specific immune responses in GBM patients at first or second recurrence. II. Assess the relationship between ability tumor induced TAA-specific immune responses and evidence of immunosuppression (peripheral blood immunophenotyping by flow cytometry) following autologous DC / allogeneic GBM culture lysate vaccination in GBM patients at first or second recurrence. III. Assess the relationship between efficacy endpoints (survival, progression-free survival, tumor response) and tumor-associated antigen immune response following autologous DC / allogeneic GBM culture lysate vaccination IV. Assess the relationship between efficacy endpoints (survival, progression-free survival, tumor response) and evidence of immunosuppression at baseline and over time with autologous DC / allogeneic GBM culture lysate vaccination. OUTLINE: Patients receive malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine intradermally (ID) on days 1, 3, and 5 of courses 2 and 3, and on day 1 of subsequent courses. Treatment with malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine repeats every 21 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for up to 5 years.

Conditions

• Giant Cell Glioblastoma
• Recurrent Glioblastoma
• Recurrent Gliosarcoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccine	Given ID

Timeline

• Start date: 2013-11-27
• Primary completion: 2021-06-02
• Completion: 2021-06-02
• First posted: 2017-12-04
• Last updated: 2023-06-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study