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Brain Interstitium Temozolomide Concentration Pre and Post Regadenoson Administration

NCT02389738 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-11-20

Study results available
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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.

Conditions

  • Blood Brain Barrier Defect

Interventions

DRUG

Regadenoson

Regadenoson administration on post-op day 2 after temozolomide administration. Temozolomide plasma and dialysate concentrations will be obtained over 18 hours post temozolomde administration.

DRUG

Temozolomide

Temozolomide administration on post-op day 1 and 2. Temozolomide plasma and dialysate concentrations will be obtained over 18 hours post temozolomde administration.

DEVICE

Microdialysis catheter

Microdialysis catheter placement post surgical resection and removed at the bedside after completion of obtaining all dialysate collections.

Sponsors & Collaborators

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Stuart Grossman, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-02-29
Completion
2018-02-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02389738 on ClinicalTrials.gov