Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02389738 : Brain Interstitium Temozolomide Concentration Pre and Post Regadenoson Administration
PhaseEarly Phase 1
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Age ? 18

- Diagnosis of recurrent high grade glioma confirmed by frozen pathology
intra-operatively

- Patients with planned surgical debulking or biopsy

- Karnofsky performance status (KPS) ? 60%

- Mini Mental Status Exam ? 15

- Adequate hepatic function

- Total bilirubin ? 1.8 mg/dL

- Serum levels of aspartate aminotransferase ? 3x the institutional upper limit of
normal

- Adequate renal function

- Serum creatinine ? 1.5mg/dL

- Adequate bone marrow function

- ANC ? 1500 cells/mm3

- Platelet count ? 100,000 cells/mm3

Exclusion Criteria:

- Currently receiving chemotherapy, or radiation therapy

- Allergic to temozolomide

- Pregnant or breast-feeding

- Have a serious medical or psychiatric illness or social situation that could interfere
with catheter placement or monitoring

- Prior use of VEGF or VEGFR-targeted therapy

- Use of medications: Vincristine, Vinblastine, Rifampin, Opioid's, Antidepressants
within the past 24 hours

- Use of investigational agents within the past 4 weeks

- NCI CTC Grade 3 or greater baseline neurologic symptoms

- History of cardiac disease:

- Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular
block (second or third degree heart block)

- History of sinus node dysfunction

- History of symptomatic sinus bradycardia or recorded (heart rate <40/minute)

- Use of dipyridamole, dipyridamole-containing medications

- Any history of coronary heart disease defined by prior myocardial infarction or
ischemia on cardiac stress testing or coronary stenosis ?50% severity

- Moderate or severe aortic stenosis

- Uncontrolled hypertension (BP >200/110)

- Decompensated or inadequately controlled congestive heart failure.

- Acute pulmonary embolism

- Acute myocarditis or pericarditis

- Acute aortic dissection

- Severe pulmonary hypertension

- Hypertrophic obstructive cardiomyopathy

- Electrolyte abnormalities

- Unexplained chest pain that may be anginal in nature

- Use of sublingual nitroglycerin

- History of Regadenoson hypersensitivity

- Known symptomatic hypotension, uncontrolled hypertension within 30 days

- History of moderate to severe bronchospastic lung disease (including moderate to
severe asthma)

- Use of aminophylline in the last 24 hours

- Use methylxanthine or caffeine in the last 12 hours

- Contraindication to adenosine (e.g., bronchoconstrictive/bronchospastic disease)

- Use of potassium supplements or potassium sparing medications in the past 24 hours

- Any patient not deemed medically stable by a physician

- Recent history of illicit drug use (past 3 months)
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02389738      |      Link to official Clinicaltrials.gov listing
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