NCT01635283

Vaccine for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma

A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen for the Treatment of Low-grade Glioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this phase II clinical trial is to determine the safety and effect on survival of patients autologous dendritic cells pulsed with autologous tumor lysate as a treatment for low-grade glioma patients. Other goals of this study are to determine if the vaccine can cause an immune response against patients' cancer cells and slow the growth of their brain tumors

Detailed description

PRIMARY OBJECTIVES: I. To determine the 5-year progression-free survival (PFS), using intradermal injections of autologous dendritic cells harvested from peripheral blood precursors and pulsed (co-cultured) with tumor lysate derived from surgical tissues in patients with low-grade gliomas. SECONDARY OBJECTIVES: I. To monitor overall survival (OS), and cellular immune responses in brain tumor patients injected with tumor lysate-pulsed dendritic cells. OUTLINE: Patients receive tumor lysate-pulsed autologous dendritic cell vaccine intradermally (ID) on days 0, 14, and 28.

Conditions

• Adult Diffuse Astrocytoma
• Adult Mixed Glioma
• Adult Oligodendroglioma
• Recurrent Adult Brain Tumor
• Adult Oligoastrocytoma

Interventions

Type	Name	Description
BIOLOGICAL	tumor lysate-pulsed autologous dendritic cell vaccine	Given ID
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2012-01-10
• Primary completion: 2016-05-13
• Completion: 2016-05-13
• First posted: 2012-07-09
• Last updated: 2020-11-04
• Results posted: 2020-11-04

Locations

1 site across 1 country: United States