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

October 14, 2020 updated by: Jonsson Comprehensive Cancer Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Jonsson Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%
  • Blood urea nitrogen (BUN) or creatinine =< 1.5 times institutional normals

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (tumor lysate-pulsed autologous dendritic cells)
Patients receive autologous glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 0, 14, and 28.
Other: laboratory biomarker analysis
Correlative studies
Biological: tumor lysate-pulsed autologous dendritic cell vaccine
Given ID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate
Time Frame: Each case was assessed from the baseline date of surgery to MRI evidence of tumor progression through study completion, up to 44 months.
a Kaplan-Meier curve of the PFS of our trial patients was created and compared to the PFS of control patients matched for tumor grade, recurrence number, IDH1 status and 1p/19q status.
Each case was assessed from the baseline date of surgery to MRI evidence of tumor progression through study completion, up to 44 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: The timeframe for OS was from the date of surgery until the date of death from any cause, up to 44 months.
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. a Kaplan-Meier curve of the OS of our trial patients was created and compared to the OS of control patients matched for tumor grade, recurrence number, IDH1 status and 1p/19q status.
The timeframe for OS was from the date of surgery until the date of death from any cause, up to 44 months.
Anti-tumor Immune Responses
Time Frame: Tumor for analysis (CD8, Programmed Death (PD)-1, PD-L1, mutation analysis) was collected at the vaccine-related surgery shortly after enrollment. Blood for analysis (IDH1-specific antibodies) was collected at Day 0, before the first vaccine injection.

Tumor and peripheral blood samples were collected from each of the participants and analyzed for the following biomarkers:

IDH1-specific antibodies CD8, PD-1, and PD-L1 content, and correlations among those three biomarkers Mutation analysis/sequencing
Tumor for analysis (CD8, Programmed Death (PD)-1, PD-L1, mutation analysis) was collected at the vaccine-related surgery shortly after enrollment. Blood for analysis (IDH1-specific antibodies) was collected at Day 0, before the first vaccine injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Investigators

  • Principal Investigator: Robert Prins, Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2012

Primary Completion (Actual)

May 13, 2016

Study Completion (Actual)

May 13, 2016

Study Registration Dates

First Submitted

June 22, 2012

First Submitted That Met QC Criteria

July 3, 2012

First Posted (Estimate)

July 9, 2012

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

October 14, 2020

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-002665
  • NCI-2012-00980 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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