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NCT02193347 · ClinicalTrials.gov registry record · Phase 1
IDH1 Peptide Vaccine for Recurrent Grade II Glioma
A Phase 1 study of Brain Tumor and Brain Cancer, sponsored by Katy Peters, MD, PhD.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT02193347: Completed Phase 1 study of Brain Tumor and Brain Cancer, sponsored by Katy Peters, MD, PhD.
NCT02193347 is a Phase 1 study of Brain Tumor and Brain Cancer that has completed, run by Katy Peters, MD, PhD. The registered enrollment target is 24 participants, below the 281-participant average among 69 other Brain Tumor trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02193347, a Phase 1 study of Brain Tumor and Brain Cancer, has completed, sponsored by Katy Peters, MD, PhD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Potential subjects with progressive Grade II primary brain tumor that have IDH1 positive testing from the primary tumor (initial diagnosis) will be offered this treatment study in order to test the safety of the PEPIDH1M vaccine in combination with standard chemotherapy (temozolomide).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Temozolomide
- BIOLOGICAL PEPIDH1M vaccine
- BIOLOGICAL Tetanus-Diphtheria Toxoid (Td)
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-01-28 |
| Est. Completion | 2020-02-03 |
| Phase | Phase 1 |
What the finished NCT02193347 record still lists
NCT02193347 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 281-participant average among 69 other Brain Tumor trials with a reported enrollment target (91% lower).
The record links to 5 conditions, with Brain Tumor appearing as the primary indexed condition, and to 3 interventions - of which Temozolomide is the first listed.
NCT02193347 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02193347 about?
NCT02193347 is a clinical study titled "IDH1 Peptide Vaccine for Recurrent Grade II Glioma". Potential subjects with progressive Grade II primary brain tumor that have IDH1 positive testing from the primary tumor (initial diagnosis) will be offered this treatment study in order to test the safety of the PEPIDH1M vaccine in combination with standard chemotherapy (temozolomide).
What is the current status of trial NCT02193347?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-01-28. Estimated completion is 2020-02-03.
What conditions does trial NCT02193347 study?
This clinical trial studies the following conditions: Brain Tumor, Brain Cancer, Brain Neoplasm, Primary, Brain Neoplasms, Recurrent, Cancer of the Brain.
What interventions are being tested in trial NCT02193347?
The interventions under investigation include: Temozolomide (DRUG), PEPIDH1M vaccine (BIOLOGICAL), Tetanus-Diphtheria Toxoid (Td) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02193347?
This trial is sponsored by Katy Peters, MD, PhD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02193347 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02193347's enrollment target sits among peer trials
24 54th of 69 higher than 16 of 69 other Brain Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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