With the help of CNI and the Sarah Cannon Cancer Research Institute we now have 9 clinical trials (list below) for patients with primary CNS tumors; GBM, ependymoma, atypical meningioma, etc.This rivals Duke, UCLA, UCSF and MD Anderson in the number of trials available for brain tumor patients. 

If you could help us spread the word that our Neuro-Oncology program offers treatment for these patients and there is possible hope for these lethal diseases, we would greatly appreciate it.  

• INITIAL DIAGNOSIS
• DCVAX 
• ABT-414 (EGFR amplification)*
•  RECURRENCE
• ABT-414 (EGFR ADC)
• AZD1775 (WEE1 inhibitor) + MEDI4736 (PD-L1 inhibitor) 
• AZD8835 (PI3K inhibitor)
• INC280 (MET inhibitor) + bevacizumab
• INCB054329 (BET inhibitor) 
• Tocagen (Retrovirus)*
• VBL 111 *

 *=contract pending; will be available for recruitment by 03/2016

What is Research?

Research is a study that is done to answer a question about a certain topic or disease. Scientists do research because they don’t know for sure what works best to help you. Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. Some other words that describe research are clinical trial, protocol, survey, or experiment. It is important to understand research is not the same as treatment.

Why is Research Important?

Research has led to important discoveries that make our lives better. Research brings new drugs to treat stroke, cancer and diabetes. Research brings a better understanding about ultrasound, X-ray machines, and diagnostic tests. Research can improve medical procedures.

This is a prospective observational study. Subjects who meet the proper inclusion/exclusion criteria will be enrolled consecutively over approximately 12 months and followed for 90 days post-stroke. Treatment and outcomes are established in 3 study cohorts: Hub Hospital, Spoke Hospital, and Control Hospital.

Blue Sky Neurology is actively seeking participants for their current research studies. If you are interested and would like more information please contact any of the following investigators or our research coordinators:

• Ira Chang, MD
• Chris Fanale, MD
• Robert Pratt, MD
• Jeffrey Wagner, MD
• Rod Spencer, MD
• Paula Fisk or Lenden Neeper at Colorado Neurological Institute
  Phone: 303-806-7455 or www.thecni.org

Telestroke Care Study:

Advancing Telestroke Care: A Prospective, Observational Study

The purpose of this trial is to gather information on the effectiveness of a combination of aspirin and clopidogrel medications to help prevent another stroke from happening in people who have suffered a stroke or a transient ischemic attack. At the same time, to see if lower blood pressure has effect to help prevent another stroke from happening in people who have suffered a stroke or a transient ischemic attack.

The primary study endpoint is assessing the percent of accurate decision making for IV tPA administration in acute stroke as defined by ASA/AHA guidelines (2007, extended tPA window statement 2009) compared across the three cohorts

• Subject must be > 18 years of age
• Subject must present with an acute ischemic stroke with-in 12 hours of symptom onset

Wake up stroke:

Safety of Intravenous Thrombolytic for Wake-up Stroke

The primary aim of this study is to demonstrate the safety of IV t-PA in ischemic stroke patients who present to the ED after awakening with the symptoms of suspected ischemic stroke.

• Acute ischemic stroke that occurred during sleep or patients who wake up with focal neurological symptoms. This would include all patients who were last known to be neurologically normal the night before, but then found upon awakening with stroke deficits. It will be considered that the last known onset time is the time when the patient was last known to be well
• Age limit is 18-80
• NIHSS baseline score ≤ 25
• Administration of t-PA must occur within 3 hrs of awakening from sleep

DIAS-4:

Phase III study to evaluate the efficacy and safety of 90 ug/kg desmoteplase verses placebo in subjects with acute ischemic stroke. Treatment must be initiated within
3-9 hours from onset.

The primary objective of this study is to evaluate the efficacy of desmoteplase 90 μg/kg versus placebo in terms of favorable outcome at Day 90 in subjects with acute ischemic stroke

• Age limit 18-85 years old
• The subject shows occlusion or high-grade stenosis as assessed by MRA or CTA in proximal cerebral arteries that corresponds to the acute clinical deficit. Eligible vessels are the middle cerebral artery MCA M1, MCA M2, anterior cerebral artery (ACA) or posterior cerebral artery (PCA)
• NIHSS 4-24

Point:

High risk TIA with an ABCD score of ≥ 4 OR minor ischemic stroke with NIHSS ≤ 3 Enrollment:

The purpose of the study is to determine whether clopidogrel 75 mg/day by mouth after a loading dose of 600 mg of clopidogrel is effective in preventing major ischemic vascular events (ischemic stroke, myocardial infarction, and ischemic vascular death) at 90 days when subjects are randomized within 12 hours of time last known free of new ischemic symptoms in patients receiving aspirin 50-325 mg/day (with a dose of 162 mg daily for 5 days followed by 81 mg daily strongly recommended)

• Patients’ NIHSS needs to be 3 or less
• ABCD score 4 or greater

Stellar:

Prospective, Double-Blind, Sham-Controlled, Randomized, Multi-Center Safety and Preliminary Efficacy Study of IV rt-PA versus IV rt-PA plus Transcranial Laser Therapy (TLT)

The purpose of the study is to assess the safety and preliminary efficacy of combining intravenous tPA with transcranial laser therapy (TLT) with the NeuroThera® Laser System in subjects treated for acute ischemic stroke. Treatment with IV tPA must begin within 3 hours of symptom onset, and the initiation of the TLT procedure must begin no sooner than12 hours after the initiation of tPA treatment, and no greater than 24 hours from stroke onset. The NeuroThera® Laser System, which provides low-energy infrared laser irradiation, is an investigational device that provides noninvasive transcranial laser therapy to subjects diagnosed with acute ischemic stroke.

• Age limit 40-80 years old
• NIHSS >7 and < 17 prior to TPA administration
• Can initiate the TLT within 24 hours from stroke onset

S-STREAM:

A Multicenter Observational Study to Evaluate the Simplified-STroke REhabilitation Assessment of Movement (S-STREAM) Scale in Subjects Obtained Between 24 and 48 Hours of a Nonhemorrhagic Ischemic Stroke

The purpose of the study is to determine the variability of the improvement from Day 1 to 3 months in the S-STREAM score in order to estimate the sample size for the planned proof of concept study and to ascertain the applicability of the S-STREAM to assess improvement in motor function when obtained between 24 and 48 hours following a mild-to-moderately severe nonhemorrhagic ischemic stroke

1. Age 21-85
2. First onset acute stroke that is seen between 24 and 48 hours from onset

ATACH-II:

A Phase III Randomized Multicenter Clinical Trial of Blood Pressure Reduction for Hypertension in Acute Intracerebral Hemorrhage

The purpose of the study is to determine the therapeutic benefit of intensive SBP treatment (SBP<140 mmHg) compared with standard SBP treatment (SBP<180 mmHg) in reducing the proportion of patients with death and disability (mRS of 4-6) at Day 90 among subjects with ICH treated within 4.5 hours of symptom onset.

• Age 18 years or older
• IV Nicardipine can be initiated within 4.5 hours of symptom onset
• Patient can be randomized within 4.5 hours of symptom onset