Spots Global Cancer Trial Database for Vaccine for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma

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We do not endorse or review these studies in any way.

Trial Identification

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

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

Study ID: NCT01635283

Conditions

Adult Diffuse Astrocytoma

Adult Mixed Glioma

Adult Oligodendroglioma

Recurrent Adult Brain Tumor

Adult Oligoastrocytoma

Interventions

tumor lysate-pulsed autologous dendritic cell vaccine

laboratory biomarker analysis

Study Description

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 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.