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NCT03299309 · ClinicalTrials.gov registry record · Phase 1
PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma
A Phase 1 study of Malignant Glioma and Recurrent Medulloblastoma, sponsored by Daniel Landi.
- Active
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03299309: Active Phase 1 study of Malignant Glioma and Recurrent Medulloblastoma, sponsored by Daniel Landi.
NCT03299309 is a Phase 1 study of Malignant Glioma and Recurrent Medulloblastoma that is active but no longer recruiting, run by Daniel Landi. The registered enrollment target is 30 participants, below the 91-participant average among 40 other Malignant Glioma trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03299309, a Phase 1 study of Malignant Glioma and Recurrent Medulloblastoma, is active but no longer recruiting, sponsored by Daniel Landi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary goal of this prospective clinical trial is to evaluate the safety of PEP-CMV in patients with recurrent medulloblastoma and malignant glioma. Patients with histologically-proven medulloblastoma or malignant glioma who had received prior therapy for their initial diagnosis and subsequently had tumor recurrence/progression may be enrolled any time after recurrence/progression regardless of prior adjuvant therapy. PEP-CMV is a vaccine comprised of Component A, a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. In May 2021, enrollment on the study was temporarily suspended due to delays in vialing the PEP-CMV study vaccine.
Primary Outcome
Evaluate the safety of PEP-CMV in pediatric patients with recurrent MB or recurrent Grade III/IV glioma
Conditions Studied
Interventions
- DRUG PEP-CMV
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-06-29 |
| Est. Completion | 2026-04 |
| Phase | Phase 1 |
What the registry record for NCT03299309 still lists
NCT03299309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 91-participant average among 40 other Malignant Glioma trials with a reported enrollment target (67% lower).
The record links to 3 conditions, with Malignant Glioma appearing as the primary indexed condition, and to 1 intervention - of which PEP-CMV is the first listed.
NCT03299309 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03299309 about?
NCT03299309 is a clinical study titled "PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma". The primary goal of this prospective clinical trial is to evaluate the safety of PEP-CMV in patients with recurrent medulloblastoma and malignant glioma. Patients with histologically-proven medulloblastoma or malignant glioma who had received prior therapy for their initial diagnosis and subsequentl...
What is the current status of trial NCT03299309?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2018-06-29. Estimated completion is 2026-04.
What conditions does trial NCT03299309 study?
This clinical trial studies the following conditions: Malignant Glioma, Recurrent Medulloblastoma, Recurrent Brain Tumor, Childhood.
What interventions are being tested in trial NCT03299309?
The interventions under investigation include: PEP-CMV (DRUG).
Who is sponsoring clinical trial NCT03299309?
This trial is sponsored by Daniel Landi, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03299309 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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Where NCT03299309's enrollment target sits among peer trials
30 25th of 40 higher than 15 of 40 other Malignant Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Glioma 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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