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NCT02389738 · ClinicalTrials.gov registry record · Early Phase 1
Brain Interstitium Temozolomide Concentration Pre and Post Regadenoson Administration
A Early Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 6
- Enrollment target
NCT02389738: Completed Early Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT02389738 is a Early Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 6 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02389738, a Early Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The blood-brain barrier (BBB) is an intricate barrier composed of a variety of efflux pumps, a luminal negative charge, a basal lamina and three distinct cell types: brain endothelial cells, pericytes, and astrocyte foot processes. Specifically, the BBB integrity and degree of permeability is regulated by the capillary endothelial cells in response to astrocytic signals. The strength of intercellular junctions (ex. tight junctions, adherins) amongst endothelial cells also plays a major role in permeability. Therefore, modulation of all these paracellular properties may decrease BBB integrity and thus improve drug penetration to the tumor bed. Previous studies utilizing the vasoactive peptide, Regadenoson, demonstrated transient increase in BBB permeability, allowing a 70kD dextran molecule to enter the brain of rodents. Thus, the investigators propose to evaluate brain interstitium concentrations of temozolomide pre and post Regadenoson using brain microdialysis. If Regadenoson successfully demonstrates effectiveness in disrupting the BBB, it could be of major importance in improving the outcome of patients with a variety of brain tumors and other neurologic illnesses.
Primary Outcome
The AUC-T for each day will be estimated by the trapezoid rule, based on the number of time points available for the particular evaluable patient. The PK variables will be tabulated and descriptive statistics calculated pre and post Regadenoson. The difference of AUCs will be summarized by mean and standard deviation or median and range if there is large variation from patient to patient. Means and standard deviation or mean and range will be presented for Cmax and AUC(inf) for each group. Graph
Interventions
- DRUG Temozolomide
- DRUG Regadenoson
- DEVICE Microdialysis catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2015-02 |
| Est. Completion | 2018-02-01 |
| Phase | Early Phase 1 |
What the finished NCT02389738 record still lists
NCT02389738 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 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 3 interventions - of which Temozolomide is the first listed.
NCT02389738 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02389738 about?
NCT02389738 is a clinical study titled "Brain Interstitium Temozolomide Concentration Pre and Post Regadenoson Administration". The blood-brain barrier (BBB) is an intricate barrier composed of a variety of efflux pumps, a luminal negative charge, a basal lamina and three distinct cell types: brain endothelial cells, pericytes, and astrocyte foot processes. Specifically, the BBB integrity and degree of permeability is regula...
What is the current status of trial NCT02389738?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2015-02. Estimated completion is 2018-02-01.
What interventions are being tested in trial NCT02389738?
The interventions under investigation include: Temozolomide (DRUG), Regadenoson (DRUG), Microdialysis catheter (DEVICE).
Who is sponsoring clinical trial NCT02389738?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02389738's enrollment target sits among peer trials
6 1845th of 2000 higher than 114 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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