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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01400672
The ClinicalTrials.gov registry entry for NCT01400672 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Radiation therapy is the first listed.
NCT01400672 reports 0 study locations.
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.
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