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NCT01400672 · ClinicalTrials.gov registry record · Phase 1
Imiquimod/Brain Tumor Initiating Cell (BTIC) Vaccine in Brain Stem Glioma
A Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT01400672: Clinical Trial Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT01400672 is a Phase 1 study that was terminated before completion, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01400672, a Phase 1 study, was terminated before completion, sponsored by Masonic Cancer Center, University of Minnesota.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is a pilot/feasibility study. The study design represents a modification of current standard of care for Diffuse Intrinsic Pontine Glioma (DIPG) (5580 cGY involved field radiation), with the final two doses of radiation given at intervals during the vaccination phase of treatment. Patients between the ages of 3 years and 25 years diagnosed with Diffuse Intrinsic Pontine Glioma (DIPG) will be allowed to participate in the trial. Study enrollment will occur after the completion of conformal radiation therapy to a dose of 5580 cGy and the post radiation therapy (RT) magnetic resonance imaging (MRI) shows no disease progression. Three patients with glioblastoma multiforme, aged 16 years and older, will be entered first to confirm vaccine safety before enrolling DIPG patients.
Primary Outcome
Determined as Grade 3 or 4 toxicity observation after dosing with BTIC vaccination. Toxicity will be graded using the NCI's Common Terminology Criteria for Adverse Events (CTCAE 4.0) in terms of local, regional and systemic events.
Interventions
- RADIATION Radiation therapy
- DRUG Imiquimod
- BIOLOGICAL Tumor Lysate Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2012-07-17 |
| Est. Completion | 2018-10-08 |
| Phase | Phase 1 |
Why NCT01400672 stopped before completion
NCT01400672 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Radiation therapy is the first listed.
NCT01400672 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01400672 about?
NCT01400672 is a clinical study titled "Imiquimod/Brain Tumor Initiating Cell (BTIC) Vaccine in Brain Stem Glioma". This is a pilot/feasibility study. The study design represents a modification of current standard of care for Diffuse Intrinsic Pontine Glioma (DIPG) (5580 cGY involved field radiation), with the final two doses of radiation given at intervals during the vaccination phase of treatment. Patients bet...
What is the current status of trial NCT01400672?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2012-07-17. Estimated completion is 2018-10-08.
What interventions are being tested in trial NCT01400672?
The interventions under investigation include: Radiation therapy (RADIATION), Imiquimod (DRUG), Tumor Lysate Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01400672?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01400672's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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