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NCT02444546 · ClinicalTrials.gov registry record · Phase 1
Wild-Type Reovirus in Combination With Sargramostim in Treating Younger Patients With High-Grade Relapsed or Refractory Brain Tumors
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT02444546: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT02444546 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02444546, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and the best dose of wild-type reovirus (viral therapy) when given with sargramostim in treating younger patients with high grade brain tumors that have come back or that have not responded to standard therapy. A virus, called wild-type reovirus, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells. Sargramostim may increase the production of blood cells and may promote the tumor cell killing effects of wild-type reovirus. Giving wild-type reovirus together with sargramostim may kill more tumor cells.
Primary Outcome
MTD is the highest safely tolerated dose level where 1 of 6 patients experience DLT with the next higher dose having at least 2 patients out of a maximum of 6 patients experience DLT.
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Sargramostim
- BIOLOGICAL Wild-type Reovirus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2015-06-21 |
| Est. Completion | 2022-11-21 |
| Phase | Phase 1 |
What the finished NCT02444546 record still lists
NCT02444546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02444546 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02444546 about?
NCT02444546 is a clinical study titled "Wild-Type Reovirus in Combination With Sargramostim in Treating Younger Patients With High-Grade Relapsed or Refractory Brain Tumors". This phase I trial studies the side effects and the best dose of wild-type reovirus (viral therapy) when given with sargramostim in treating younger patients with high grade brain tumors that have come back or that have not responded to standard therapy. A virus, called wild-type reovirus, which has...
What is the current status of trial NCT02444546?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2015-06-21. Estimated completion is 2022-11-21.
What interventions are being tested in trial NCT02444546?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Sargramostim (BIOLOGICAL), Wild-type Reovirus (BIOLOGICAL).
Who is sponsoring clinical trial NCT02444546?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02444546's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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