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NCT02366728 · ClinicalTrials.gov registry record · Phase 2
DC Migration Study for Newly-Diagnosed GBM
A Phase 2 study, sponsored by Mustafa Khasraw, MBChB, MD, FRCP, FRACP.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
NCT02366728: Completed Phase 2 study, sponsored by Mustafa Khasraw, MBChB, MD, FRCP, FRACP.
NCT02366728 is a Phase 2 study that has completed, run by Mustafa Khasraw, MBChB, MD, FRCP, FRACP. The registered enrollment target is 64 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02366728, a Phase 2 study, has completed, sponsored by Mustafa Khasraw, MBChB, MD, FRCP, FRACP.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
Study Summary
This randomized phase II study will assess the impact of pre-conditioning on migration and survival among newly diagnosed glioblastoma (GBM) patients who have undergone definitive resection and completed standard temozolomide (TMZ) and radiation treatment, as well as the impact of tetanus pre-conditioning and basiliximab together on survival. After completing standard of care radiotherapy with concurrent TMZ, patients will be randomized to 1 of 3 treatment arms: 1). receive cytomegalovirus (CMV)-specific dendritic cell (DC) vaccines with unpulsed (not loaded) DC pre-conditioning prior to the 4th vaccine; 2). receive CMV-specific DC vaccines with Tetanus-Diphtheria Toxoid (Td) pre-conditioning prior to the 4th vaccine; 3). receive basiliximab infusions prior to the 1st and 2nd DC vaccines along with Td pre-conditioning prior to the 4th vaccine. A permuted block randomization algorithm using a 1:1:1 allocation ratio will be used to assign patients to a treatment arm. Randomization will be stratified by CMV status (positive, negative), with the assignment to arms I and II being double-blinded. Effective March 2017, randomization to Group III has been terminated.
Primary Outcome
Overall survival will be defined as the time in months between randomization and death, or last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.
Interventions
- DRUG Temozolomide
- BIOLOGICAL Human CMV pp65-LAMP mRNA-pulsed autologous DCs
- BIOLOGICAL Td
- BIOLOGICAL Unpulsed DCs
- BIOLOGICAL 111In-labeled DCs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2015-10-12 |
| Est. Completion | 2020-10-31 |
| Phase | Phase 2 |
What the finished NCT02366728 record still lists
NCT02366728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 5 interventions - of which Temozolomide is the first listed.
NCT02366728 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02366728 about?
NCT02366728 is a clinical study titled "DC Migration Study for Newly-Diagnosed GBM". This randomized phase II study will assess the impact of pre-conditioning on migration and survival among newly diagnosed glioblastoma (GBM) patients who have undergone definitive resection and completed standard temozolomide (TMZ) and radiation treatment, as well as the impact of tetanus pre-condit...
What is the current status of trial NCT02366728?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2015-10-12. Estimated completion is 2020-10-31.
What interventions are being tested in trial NCT02366728?
The interventions under investigation include: Temozolomide (DRUG), Human CMV pp65-LAMP mRNA-pulsed autologous DCs (BIOLOGICAL), Td (BIOLOGICAL), Unpulsed DCs (BIOLOGICAL), 111In-labeled DCs (BIOLOGICAL).
Who is sponsoring clinical trial NCT02366728?
This trial is sponsored by Mustafa Khasraw, MBChB, MD, FRCP, FRACP, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02366728's enrollment target sits among peer trials
64 996th of 2000 higher than 992 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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