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Vaccine for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma | Clinical Trials | Clareo Health

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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

NCT01635283•Jonsson Comprehensive Cancer Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with newly diagnosed or recurrent glioma of World Health Organization (WHO) grade II (astrocytoma, oligodendroglioma, and/or oligoastrocytoma) will be eligible for this protocol
•Patients must have had surgical resection at University of California, Los Angeles (UCLA), for which a separate informed consent was signed for the collection of their tumor prior to surgery
•After surgery, a pathological diagnosis of low-grade glioma (WHO grade II) will need to be established
•Patients must be able to read and understand the informed consent document; patients must sign the informed consent indicating that they are aware of the investigational nature of this study.
•Patients must have a Karnofsky performance status (KPS) rating of \>= 60 prior to initiating treatment; patients may be enrolled at a KPS of \< 60 if it is felt that the patient will have adequate opportunity to recover to a KPS of \>= 60 by the initiation of treatment
•Hemoglobin \>= 9 gm%
•Absolute granulocyte count \>= 1,500
•Platelet count \>= 100,000/microliter (uL)
•Serum glutamic pyruvate transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT) =\< 2.5 times institutional normals
•Bilirubin =\< 1.5mg%
+1 more criteria

Exclusion Criteria

•Subjects with an active infection
•Inability to obtain informed consent because of psychiatric or complicating medical problems
•Unstable or severe intercurrent medical or psychiatric conditions as determined by the Investigator
•Females of child-bearing potential who are pregnant or lactating or who are not using approved contraception
•History of immunodeficiency (e.g., human immunodeficiency virus \[HIV\]) or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, vasculitis, polymyositis-dermatomyositis, scleroderma, multiple sclerosis, or juvenile-onset insulin-dependent diabetes) that may be exacerbated by immunotherapy
•Subjects with organ allografts
•Inability or unwillingness to return for required visits and follow-up exams
•Subjects who have an uncontrolled systemic malignancy that is not in remission

Locations (1)

Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Key Dates

Start Date

January 10, 2012

Primary Completion Date

May 13, 2016

Completion Date

May 13, 2016

Last Updated

November 4, 2020

Enrollment

ACTUAL participants

Conditions

Adult Diffuse AstrocytomaAdult Mixed GliomaAdult OligodendrogliomaRecurrent Adult Brain TumorAdult Oligoastrocytoma

Interventions

tumor lysate-pulsed autologous dendritic cell vaccine

BIOLOGICAL

laboratory biomarker analysis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 4, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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