Trial · NCT02549833
Neo-adjuvant Evaluation of Glioma Lysate Vaccines in WHO Grade II Glioma
NCT02549833, Phase 1, Completed, Jennie Taylor
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neo-adjuvant Evaluation of Glioma Lysate Vaccines in WHO Grade II Glioma. Trials, record NCT02549833. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02549833
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neo-adjuvant Evaluation of Glioma Lysate Vaccines in WHO Grade II Glioma
- NCT number
- NCT02549833
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 28 participants, actual
- Lead sponsor
- Jennie Taylor
- Conditions
- Oligodendroglioma, Astrocytoma, Grade II, Glioma, Astrocytic, Glioma, Malignant Glioma, Oligoastrocytoma, Mixed
- Interventions
- GBM6-AD and poly-ICLC before and after surgery, GBM6-AD and poly-ICLC after surgery only
- First posted
- 2015-09-15
- Last updated
- 2024-11-22
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Regimen Limiting Toxicity (RLT) | until disease progression, start of a new therapy, or for a maximum of 18 months from study registration (whichever occurs earlier) | Delay of the scheduled surgery for longer than 2 weeks due to toxicity of the neoadjuvant treatment will also be considered RLT and reported for each arm will be tabulated with 95% exact (ClopperPearson) confidence intervals |
| Primary | Measurement of vaccine-induced immune response in the resected tumor | At time of surgery (as clinically indicated) | Evaluate whether surgically resected tumors from Arm 1 (the neoadjuvant arm) patients demonstrate significantly higher levels of CD8+ T-cell infiltration and CXCL10 expression compared with those resected from Arm 2 (control) patients The mean CD8+ T-cells in TILs and CXCL10 expression will be compared between arms by means of a two-sample Student's t test. If the t test assumptions are not met and the data cannot be transformed in such a way that the assumptions are met, a Wilcoxon Rank Sum test will be used |
| Secondary | Response rate of CD4+ and CD8+ T-cell responses against the GM6-AD lysate in pre- and post-vaccine peripheral blood mononuclear cell (PBMC) using IFN-γ-ELISPOT | at Baseline, At time of surgery (as clinically indicated), Weeks 1, 10 and 16 post-surgery | To describe the response rate and magnitude of CD4+ and CD8+ T-cell responses against the GBM6-AD lysate in pre- and postvaccine PBMC using interferon (IFN)-γ-ELISPOT. Further, we will determine whether T-cell clonotypes changes in PBMC during the course of the vaccines. We will also determine whether T-cell clonotypes that increased in post-vaccine PBMC are found in tumor infiltrating lymphocytes (TILs). |
| Secondary | Magnitude of response of CD4+ and CD8+ T-cell responses against the GM6-AD lysate in pre- and post-vaccine PBMC using IFN-γ-ELISPOT | at Baseline, At time of surgery (as clinically indicated), Weeks 1, 10 and 16 post-surgery | To describe the response rate and magnitude of CD4+ and CD8+ T-cell responses against the GBM6-AD lysate in pre- and postvaccine PBMC using interferon (IFN)-γ-ELISPOT. Further, we will determine whether T-cell clonotypes changes in PBMC during the course of the vaccines. We will also determine whether T-cell clonotypes that increased in post-vaccine PBMC are found in tumor infiltrating lymphocytes (TILs). |
| Secondary | Tumor tissue expression of glioma-associated antigens (GAAs) and antigen-presentation machinery (APM) molecules | At the time of clinically indicated surgical resection of the tumor | To describe tumor tissue expression of glioma-associated antigens (GAAs) and antigen-presentation machinery (APM) molecules. We will evaluate whether there are changes in GAA and APM expression status over the course |
| Secondary | Overall survival (OS) | Minimum of 2 years | OS is defined as the duration of time from start of treatment to death. All patients will be followed for a minimum of 2 years |
| Secondary | Objective response rate (ORR) | Minimum of 2 years | objective response rate (ORR) will be tabulated by response according to low-grade gliomas (LGG) Response Assessment in Neuro-Oncology (RANO) |
| Secondary | Progression-free survival (PFS) | Minimum of 2 years | PFS is defined as the duration of time from start of treatment to time of progression. All patients will be followed for a minimum of 2 years. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34882581 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02549833
GET https://conductscience.org/api/trials/v1/NCT02549833/registered