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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01635283
Recruitment Status : Completed
First Posted : July 9, 2012
Results First Posted : November 4, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Diffuse Astrocytoma
Adult Mixed Glioma
Adult Oligodendroglioma
Recurrent Adult Brain Tumor
Adult Oligoastrocytoma
Interventions Biological: tumor lysate-pulsed autologous dendritic cell vaccine
Other: laboratory biomarker analysis
Enrollment 5
Recruitment Details Dates of recruitment period: 1/2012 - 8/2015 Types of location: Medical clinic
Pre-assignment Details Study enrollment patients must satisfy inclusion criteria, screening evaluations (vital signs, history, physical, neurological exams, Karnofsky Performance Scale, brain MRI , urinalysis, complete blood count, differential, platelets, coagulation tests), underwent leukapheresis, and had suitable Dendritic Cell (DC) Vaccine manufactured for them.
Arm/Group Title Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)
Hide Arm/Group Description

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

tumor lysate-pulsed autologous dendritic cell vaccine: Given ID

laboratory biomarker analysis: Correlative studies
Period Title: Overall Study
Started 5
Completed 1
Not Completed 4
Reason Not Completed
Tumor Progression             3
Lost to Follow-up             1
Arm/Group Title Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)
Hide Arm/Group Description

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

tumor lysate-pulsed autologous dendritic cell vaccine: Given ID

laboratory biomarker analysis: Correlative studies
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
46.2  (21.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
2
  40.0%
Male
3
  60.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate
Hide 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.
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Hide Analysis Population Description
Completed the maximum time allowed on study without being affected by Tumor Recurrence or Progression.
Arm/Group Title Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)
Hide Arm/Group Description:

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

tumor lysate-pulsed autologous dendritic cell vaccine: Given ID

laboratory biomarker analysis: Correlative studies
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
0-6 months 0
7-12 months 1
13-18 months 1
19-24 months 1
25-30 months 0
>30 months 2
2.Secondary Outcome
Title Overall Survival (OS)
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)
Hide Arm/Group Description:

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

tumor lysate-pulsed autologous dendritic cell vaccine: Given ID

laboratory biomarker analysis: Correlative studies
Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
Deceased
0
   0.0%
Alive
5
 100.0%
Lost to Follow-Up
0
   0.0%
Withdrawal by Subject
0
   0.0%
3.Secondary Outcome
Title Anti-tumor Immune Responses
Hide 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.
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Hide Analysis Population Description
Quantitative multiplex immuno-histochemical (IHC) of pre-treatment glioma microenvironment of IDH1-specific antibodies
Arm/Group Title %CD8+/Field %PD-1+/Field %PD-L1+/Field
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 5 5 5
Mean (Standard Deviation)
Unit of Measure: percentage of cells per field
1.26  (1.03) 1.35  (1.04) 6.76  (3.30)
Time Frame The timeframe for adverse event reporting was from the day of the first vaccine treatment until the patient discontinued the study for any reason, up to 44 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)
Hide Arm/Group Description

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

tumor lysate-pulsed autologous dendritic cell vaccine: Given ID

laboratory biomarker analysis: Correlative studies
All-Cause Mortality
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)
Affected / at Risk (%)
Total   0/5 (0.00%)    
Hide Serious Adverse Events
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)
Affected / at Risk (%) # Events
Total   0/5 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)
Affected / at Risk (%) # Events
Total   3/5 (60.00%)    
Blood and lymphatic system disorders   
Anemia * 1  1/5 (20.00%)  1
Gastrointestinal disorders   
Nausea * 1  1/5 (20.00%)  1
General disorders   
Headache * 1  2/5 (40.00%)  2
Fatigue * 1  2/5 (40.00%)  2
Rhinorrhea * 1  1/5 (20.00%)  1
Infections and infestations   
Urinary Tract Infection * 1  1/5 (20.00%)  1
Upper respritory infection * 1  1/5 (20.00%)  1
Musculoskeletal and connective tissue disorders   
Fractures * 1  1/5 (20.00%)  1
Myalgia * 1  1/5 (20.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Squamous cell carcinomas * 1  1/5 (20.00%)  1
Nervous system disorders   
Seizure * 1  2/5 (40.00%)  2
Dysphasia * 1  1/5 (20.00%)  1
Visual Distortions * 1  1/5 (20.00%)  1
cognitive slowness * 1  1/5 (20.00%)  1
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robert Prins
Organization: Jonsson Comprehensieve Cancer Center
Phone: 310-825-7647
EMail: rprins@mednet.ucla.edu
Layout table for additonal information
Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01635283    
Other Study ID Numbers: 11-002665
NCI-2012-00980 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: June 22, 2012
First Posted: July 9, 2012
Results First Submitted: May 6, 2019
Results First Posted: November 4, 2020
Last Update Posted: November 4, 2020