Trial · NCT02193347
IDH1 Peptide Vaccine for Recurrent Grade II Glioma
NCT02193347, Phase 1, Completed, Katy Peters, MD, PhD; results first posted 2021-03-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. IDH1 Peptide Vaccine for Recurrent Grade II Glioma. Trials, record NCT02193347. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02193347
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- IDH1 Peptide Vaccine for Recurrent Grade II Glioma
- NCT number
- NCT02193347
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 24 participants, actual
- Lead sponsor
- Katy Peters, MD, PhD
- Conditions
- Brain Cancer, Brain Neoplasm, Primary, Brain Neoplasms, Recurrent, Brain Tumor, Cancer of the Brain
- Interventions
- PEPIDH1M vaccine, Tetanus-Diphtheria Toxoid (Td), Temozolomide
- First posted
- 2014-07-17
- Last updated
- 2023-12-01
- Results first posted
- 2021-03-15
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With an Unacceptable Toxicity | Date of consent through 2 months after the last vaccination | The percentage of patients who experience an unacceptable toxicity defined as any Grade 3 toxicity at least possibly attributed to the vaccine (or vaccine + TMZ and/or RT) that does not resolve to baseline within 3 weeks, any Grade 3 hypersensitivity reactions requiring steroids, any Grade 4 toxicity, including neurologic events not due to progressive disease, or any life threatening-event not attributable to concomitant medication, co-morbid event, or disease progression. |
| Secondary | Percentage of Patients With a Positive Vaccine Response After 3 Post-Surgery Vaccines as Measured by IFNγ ELIspot | From time of pheresis #1, one day prior to first pre-surgery vaccine dose, until the time of the third post-surgery vaccination, an expected average of 24 weeks after study initiation | Assess the immunogenicity of the PEPIDH1M vaccine with adjuvant TMZ using ELISpot. This will be done by finding the difference between the number of SFC after 3 post-surgery vaccines and the number of SFC at baseline for each evaluable subject. Immunogenicity will then be summarized by the percentage of evaluable subjects who have a positive vaccine response after 3 post-surgery vaccines. A response will be considered positive if the difference in SFC measurement is greater than 20 SFC per 10\^6 lymphocytes after determining the level of detection in the IDH ELISpot. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With an Unacceptable Toxicity | Date of consent through 2 months after the last vaccination | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Patients With a Positive Vaccine Response After 3 Post-Surgery Vaccines as Measured by IFNγ ELIspot | From time of pheresis #1, one day prior to first pre-surgery vaccine dose, until the time of the third post-surgery vaccination, an expected average of 24 weeks after study initiation | Only 21 of the 24 overall study patients made it far enough on the study to receive 3 post-surgery vaccines and become evaluable for this outcome. | Percentage of evaluable participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With an Unacceptable Toxicity | PEPIDH1M Vaccine | 0 | percentage of participants | ||
| Percentage of Patients With a Positive Vaccine Response After 3 Post-Surgery Vaccines as Measured by IFNγ ELIspot | PEPIDH1M Vaccine | 42.86 | Percentage of evaluable participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PEPIDH1M Vaccine | 24 | |
| Overall Study | COMPLETED | PEPIDH1M Vaccine | 24 | |
| Overall Study | NOT COMPLETED | PEPIDH1M Vaccine | 0 |
Source ClinicalTrials.gov
Adverse events140
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | PEPIDH1M Vaccine | 20 | 24 | |
| other | Sinus tachycardia | Cardiac disorders | PEPIDH1M Vaccine | 1 | 24 | |
| other | Other, Specify: INNER EAR PRESSURE | Ear and labyrinth disorders | PEPIDH1M Vaccine | 1 | 24 | |
| other | Other, Specify: BLOOD TINGED DRAINAGE | Ear and labyrinth disorders | PEPIDH1M Vaccine | 1 | 24 | |
| other | Other, Specify: CLICKING SOUND IN LEFT EAR | Ear and labyrinth disorders | PEPIDH1M Vaccine | 1 | 24 | |
| other | Other, Specify: HEARS CLINKING SOUND IN HEAD INTERMITTENTLY | Ear and labyrinth disorders | PEPIDH1M Vaccine | 1 | 24 | |
| other | Blurred vision | Eye disorders | PEPIDH1M Vaccine | 3 | 24 | |
| other | Dry eye | Eye disorders | PEPIDH1M Vaccine | 2 | 24 | |
| other | Other, Specify: INTERMITTENT PAIN, TWITCHING, AND/OR NUMBNESS UNDER RIGHT EYE | Eye disorders | PEPIDH1M Vaccine | 1 | 24 | |
| other | Other, Specify: INTERMITTENT; OBJECTS APPEAR TO MOVE OR SHAKE WHEN HOLDING | Eye disorders | PEPIDH1M Vaccine | 1 | 24 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PEPIDH1M Vaccine | 0 | 24 |
| Total, other adverse events | PEPIDH1M Vaccine | 24 | 24 |
| Total, serious adverse events | PEPIDH1M Vaccine | 4 | 24 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02193347
GET https://conductscience.org/api/trials/v1/NCT02193347/events?page=2