Trial Outcomes & Findings for Vaccine for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma (NCT NCT01635283)
NCT ID: NCT01635283
Last Updated: 2020-11-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Each case was assessed from the baseline date of surgery to MRI evidence of tumor progression through study completion, up to 44 months.
Results posted on
2020-11-04
Participant Flow
Dates of recruitment period: 1/2012 - 8/2015 Types of location: Medical clinic
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.
Participant milestones
| Measure |
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.
tumor lysate-pulsed autologous dendritic cell vaccine: Given ID
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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.
tumor lysate-pulsed autologous dendritic cell vaccine: Given ID
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
Tumor Progression
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)
n=5 Participants
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
|
|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 21.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Each case was assessed from the baseline date of surgery to MRI evidence of tumor progression through study completion, up to 44 months.Population: Completed the maximum time allowed on study without being affected by Tumor Recurrence or Progression.
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.
Outcome measures
| Measure |
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)
n=5 Participants
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
|
%PD-1+/Field
|
%PD-L1+/Field
|
|---|---|---|---|
|
Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate
0-6 months
|
0 participants
|
—
|
—
|
|
Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate
7-12 months
|
1 participants
|
—
|
—
|
|
Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate
13-18 months
|
1 participants
|
—
|
—
|
|
Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate
19-24 months
|
1 participants
|
—
|
—
|
|
Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate
25-30 months
|
0 participants
|
—
|
—
|
|
Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate
>30 months
|
2 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)
n=5 Participants
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
|
%PD-1+/Field
|
%PD-L1+/Field
|
|---|---|---|---|
|
Overall Survival (OS)
Deceased
|
0 Participants
|
—
|
—
|
|
Overall Survival (OS)
Alive
|
5 Participants
|
—
|
—
|
|
Overall Survival (OS)
Lost to Follow-Up
|
0 Participants
|
—
|
—
|
|
Overall Survival (OS)
Withdrawal by Subject
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.Population: Quantitative multiplex immuno-histochemical (IHC) of pre-treatment glioma microenvironment of IDH1-specific antibodies
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
Outcome measures
| Measure |
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)
n=5 Participants
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
|
%PD-1+/Field
n=5 Participants
|
%PD-L1+/Field
n=5 Participants
|
|---|---|---|---|
|
Anti-tumor Immune Responses
|
1.26 percentage of cells per field
Standard Deviation 1.03
|
1.35 percentage of cells per field
Standard Deviation 1.04
|
6.76 percentage of cells per field
Standard Deviation 3.30
|
Adverse Events
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)
n=5 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Number of events 1 • 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.
|
|
Nervous system disorders
Seizure
|
40.0%
2/5 • Number of events 2 • 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.
|
|
Nervous system disorders
Dysphasia
|
20.0%
1/5 • Number of events 1 • 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.
|
|
Nervous system disorders
Visual Distortions
|
20.0%
1/5 • Number of events 1 • 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.
|
|
Nervous system disorders
cognitive slowness
|
20.0%
1/5 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Fractures
|
20.0%
1/5 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Number of events 1 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinomas
|
20.0%
1/5 • Number of events 1 • 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.
|
|
Infections and infestations
Urinary Tract Infection
|
20.0%
1/5 • Number of events 1 • 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.
|
|
Infections and infestations
Upper respritory infection
|
20.0%
1/5 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • 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.
|
|
General disorders
Headache
|
40.0%
2/5 • Number of events 2 • 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.
|
|
General disorders
Fatigue
|
40.0%
2/5 • Number of events 2 • 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.
|
|
General disorders
Rhinorrhea
|
20.0%
1/5 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place