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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Jonsson Comprehensive Cancer Center

Current Primary Outcome: Progression-free survival of low grade glioma patients treated with autologous dendritic cells pulsed with autologous tumor lysate [ Time Frame: Up to 5 years ]

Cox regression will be used.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall survival [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months. ]
  • Anti-tumor immune responses [ Time Frame: upto 5 years ]


Original Secondary Outcome: Same as current

Information By: Jonsson Comprehensive Cancer Center

Dates:
Date Received: June 22, 2012
Date Started: January 2012
Date Completion: December 2019
Last Updated: January 29, 2016
Last Verified: January 2016