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

Primary Purpose

Adult Diffuse Astrocytoma, Adult Mixed Glioma, Adult Oligodendroglioma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
tumor lysate-pulsed autologous dendritic cell vaccine
laboratory biomarker analysis
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Diffuse Astrocytoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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%
  • 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

Sites / Locations

  • Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (tumor lysate-pulsed autologous dendritic cells)

Arm Description

Patients receive autologous glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 0, 14, and 28.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate
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.

Secondary Outcome Measures

Overall Survival (OS)
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.
Anti-tumor Immune Responses
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

Full Information

First Posted
June 22, 2012
Last Updated
October 14, 2020
Sponsor
Jonsson Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01635283
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 Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 10, 2012 (Actual)
Primary Completion Date
May 13, 2016 (Actual)
Study Completion Date
May 13, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Diffuse Astrocytoma, Adult Mixed Glioma, Adult Oligodendroglioma, Recurrent Adult Brain Tumor, Adult Oligoastrocytoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (tumor lysate-pulsed autologous dendritic cells)
Arm Type
Experimental
Arm Description
Patients receive autologous glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 0, 14, and 28.
Intervention Type
Biological
Intervention Name(s)
tumor lysate-pulsed autologous dendritic cell vaccine
Intervention Description
Given ID
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate
Description
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.
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.
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
The timeframe for OS was from the date of surgery until the date of death from any cause, up to 44 months.
Title
Anti-tumor Immune Responses
Description
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
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Prins
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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