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HOME : KALISPELL REGIONAL HEALTHCARE FAMILY : GLACIER VIEW RESEARCH INSTITUTE

Glacier View Research Institute

What is Glacier View Research Institute?

Glacier View Research Institute (GVRI) provides the support for clinical trials that offer access to new treatment options for patients in Northwest Montana. The goal is to make the entire clinical trial process smooth from beginning to end by identifying appropriate clinical trials, Principle Investigator recruitment and training, contract and budget negotiation, site assessment regulatory affairs, research coordinator assignments, patient recruitment, data collection, quality assurance and compliance. All clinical research trials that utilize Kalispell Regional facilities and/or staff will be reviewed and approved by the GVRI Steering Committee.

Glacier View Research Institute's mission is to offer cutting edge treatment to patients in our community through clinical trials, while also benefiting society through advancement of health care.

Why research? 

Clinical research trials contribute to evidence-based medicine by helping find new and better ways to treat patients. The contribution that research makes plays a vital role in the advancement of medical therapies, medications and technologies. Without research, these advancements would not exist.

What are clinical trials? 

Clinical Trials are part of clinical research and the heart of all medical advances. Clinical Trials examine new ways to prevent, treat and detect disease. This involves using new drugs or devices, or approved drugs or devices.

Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can participate. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.

In the United States there are various committees, regulatory groups, rules and regulations (Federal, State and Local) that oversee Clinical Trials and foremost protect the safety of clinical trial participants.

(Source: NIH: National Institutes of Health)

What are the phases of clinical trials? 

Clinical research trials are conducted in phases.

Phase I – An experimental drug or treatment is given to find a safe dose, to decide how the new treatment should be given or to see how the new treatment affects the human body. Usually 10-15 people participate in the clinical trial.

Phase II – an experimental drug or treatment is given to a group of between 100 and 300 people to see if it is effective and to further evaluate its safety.

Phase III – an experimental drug or treatment is given to a larger group of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the experimental drug or treatment to be used safely.

Phase IV – post marketing studies are conducted to evaluate risks, benefits and optimal use of the drug or treatment or a new indication for already approved drugs.

What are the benefits and risks of participating in clinical trials? 

Benefits:

Clinical trials offer high-quality care. If you are in a randomized study and do not receive the new treatment being tested, you will receive the best known standard treatment. This may be as good as, or better than, the new approach.

· If a new treatment is proven to work and you are taking it, you may be among the first to benefit.

· By looking at the pros and cons of clinical trials and your other treatment choices, you are taking an active role in a decision that affects your life.

· You have the chance to help others and improve cancer treatment.

Risks:

New treatments under study are not always better than, or even as good as, standard care.

· If you receive standard care instead of the new treatment being tested, it may not be as effective as the new approach. New treatments may have side effects that doctors do not expect or that are worse than those of standard treatment.

· Even if a new treatment has benefits, it may not work for you. Even standard treatments, proven effective for many people, do not help everyone.

What are the costs of participating in clinical trials? 

There is no cost to the Clinical Trial participant. Frequently the Sponsor of the Clinical Trial provides a stipend to participants for their time and/or travel expenses.

Do I need to be referred by a physician for a clinical trial?
No, you may however request that your Primary Care Physician be notified if you decided to participate in a Clinical Trial.

Glossary of Research Terms 

Adverse Event – (AE) Is an expected or unexpected occurrence that may or may not be related to the Clinical Trial drug or device.
Beneficence – Doing no harm, maximizing benefits while minimizing risks.
Clinical Research – Study of drug, biologic or device in human subjects with the intent to discover potential beneficial effects and/or determine its safety and efficacy.
Consent Form – Contains all relevant study information explained in lay terms and documents voluntary participation of a subject. Presented to and signed by the subject.
Declaration of Helsinki – Statement of ethical principles first published by World Medical Association in 1967 to define rules for therapeutic and non-therapeutic research.
Good Clinical Practice – (GCP) International ethical and scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting studies. Insures that the data reported is credible and accurate and that subject's rights and confidentiality are protected.
Inclusion Criteria – A list of criteria that must be met by all study subjects.
Informed Consent – Information exchange including subject recruitment materials, verbal instructions, written materials, questions and answer sessions and signature documenting consent with date. Subjects are given opportunity to choose involvement based on information, comprehension and voluntariness.
Institution – Location of research. Retains ultimate responsibility for human subject regulation compliance.
Institutional Review Board – (IRB) Reviews research and consent forms to determine if rights and welfare of subjects are protected.
Investigator - Conducts and directs study. Carries ultimate responsibility for research. Is referred to as the principle investigator when acting as the leader for an investigational team. Also referred to as Clinical Investigator by the FDA.
National Institutes of Health – (NIH) Agency within Department of Health and Human Services that provides funding for research, conducts studies and funds multi-site national studies.
Patient Oriented Research – Research conducted with human subjects (or on material of human origin) in which an investigator or colleague directly interacts with human subjects.
Protocol – Documentation of study objective, design, methods, statistical methods and organization. The term also includes amendments made to the original document.
Protocol Amendment - Changes or clarifications made in writing to the original protocol.
Risk-Benefit Ratio – Risk to individual subject vs. potential benefits. Also call Risk-Benefit Analysis.
Serious Adverse Event – (SAE) Any event that results in death, a life threatening situation, hospitalization or prolonged hospitalization, disability, incapacity or a congenital anomaly/birth defect.
Standard Operating Procedure – (SOP) Detailed, written procedures for the uniform performance of a function.
Vulnerable Subjects – Group/individual that cannot give informed consent because of limited autonomy (e.g., children, mentally ill and prisoners). Also refers to subjects who may be unduly influenced to participate (e.g., students, subordinates and patients)

What current cancer clinical trials are available through Glacier View Research Institute? 

Find local cancer treatment trials though the  Montana Cancer Consortium

Find local cancer symptom management and prevention trials though the  Montana Cancer Consortium

We are actively recruiting for the following trials:

Blood Disorders
TELESTO: A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of Deferasirox in Patients With Myelodysplastic Syndromes (Low/Int-1 Risk) and Transfusional Iron Overload

Brain
High Grade
CTSU N0877: Phase I/Randomized Phase II Trial of Either Dasatinib or Placebo Combined with Standard Chemo-Radiotherapy for Newly Diagnosed Glioblastoma Multiforme

Low Grade
CTSU E3F05:Phase III Study of Radiation Therapy with or without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas

Breast
Adjuvant--Hormonal
SWOG S1207: Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of EVEROLIMUS in Patients with High-Risk, Hormone Receptor-Positive AND HER2/neu Negative Breast Cancer

Her2+
CTSU SCUSF0806: Phase II Placebo-controlled Trial of Lisinopril and Coreg CR to Reduce Cardiotoxicity in Patients with Breast Cancer Receiving (neo)Adjuvant Chemotherapy with Trastuzumab

Breast - Metastatic
BOLERO-6: Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in the Treatment of Postmenopausal Women With ER+Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Prior Letrozole or Anastrozole.

Breast Node Positive or Negative
NSABP B49: A Phase III Clinical Trial Comparing the Combination of Docetaxel plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

Cancer Pain
Sativex (recruiting late summer): A Double Blind, Randomized, Placebo Controlled, Parallel Group Study of Sativex® in Relieving Persistent Pain in Patients With Advanced Cancer, Who Experience Inadequate Analgesia During Optimized Chronic Opioid Therapy.

Colon-Rectal
Prevention Stage 0-III Colon
SWOG S0820: A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon Cancer, Phase III

Head and Neck
CTSU E1305: A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer

RTOG R1016: Phase III Trial of Radiotherapy Plus Cetuximab vs Chemotherapy in HPV-Associated Oropharynx Cancer

Lung
Non-Small Cell
AMGEN 20070782: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 µg Once-Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy

SWOG S0819: A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

CTSU C30607:Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511, IND #74019) as Maintenance Therapy in Non-Progressing Patients following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB/IV Non-Small Cell Lung Cancer

Lung-Other
SWOG S0905: A Phase I/Randomized Phase II Study of Cediranib (NSC#732208) Versus Placebo in Combination with Cisplatin and Pemetrexed in Chemonaive Patients with Malignant Pleural Mesothelioma

Melanoma
CTSU E1609: A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon α-2b for Resected High-risk Melanoma

Pancreas
RTOG R0848: A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma

Prostate
Metastatic
SWOG S1216: A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer

Renal
SWOG S0931: EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, a Phase III Study

 

For questions contact:
Phone: 406-752-8900
Fax: 406-752-8909
Email: srhoades@krmc.org

Glacier View Research Institute-Cancer
Northwest Hematology & Oncology
The Rock Medical Office Building
350 Heritage Way Ste. 1100
Kalispell, MT 59901

What current cardiology clinical trials are available through Glacier View Research Institute? 

ADVENT-HF: A multi-centre, international, randomized study to assess the effects of Adaptive Servo Ventilation (ASV) on survival and frequency of cardiovascular (CV) hospital admissions in patients with heart failure (HF) and sleep apnea (SA) to determine if treating the sleep apnea with ASV can reduce the number of hospitalizations, prolong life and improved quality of life in patients with heart failure. ASV is a device that delivers positive pressure to the airway using a face mask and is approved for the treatment of sleep apnea. Indications: HF patients with obstructive (OSA) or central sleep apnea (CSA). Patients will be screened for sleep apnea if they have HF with left ventricular ejection fraction (LVEF ≤ 45%), as determined by echocardiography at screening. Patients can not already be using CPAP or bilevel. For more information, contact Roxanne Taylor, BA, RST, RPSGT at the Sleep Center at Rocky Mountain Heart and Lung, 406-257-8979 or rtaylor@krmc.org.

BRIDGE: For Atrial Fibrillation patients on Coumadin, who need to temporarily stop it for an invasive procedure. Evaluating Fragmin vs. placebo in outcome-based trial. Contact Pat Keane-Richmond, RN, CCRC Clinical Research Nurse Coordinator. pkeane@krmc.org. 406-752-7636.  Enrolling since 2010.Indications: Patients on warfarin for stroke prophylaxis secondary to Atrial Fibrillation.  Key inclusions: at least one of the following risk factors, age > 70, HTN, Diabetes, CHF, previous stroke or TIA, need to temporarily go off warfarin for an invasive procedure. Key exclusions: mechanical heart valve, GFR < 30ml/min, thrombocytopenia.

PRECISION: An arthritis trial evaluating safety for known cardiovascular or high cardiovascular risk patients. Study medication will be Celebrex, or ibuprofen, or naproxyn. Contact Pat Keane-Richmond, RN, CCRC Clinical Research Nurse Coordinator. pkeane@krmc.org. 406-752-7636.  Enrolling since 2004.Indications: Patients diagnosed with OA or RA needing regular analgesia, with known or high risk CV disease. Key inclusions: RA/OA diagnosis, willingness to take 8 pills daily.
Key exclusions: allergies or intolerance to celecoxib, ibuprofen or naproxen, needing steroids > 20mg daily, bp > 140/90, known decreased LVEF.

EVITA: The objective is to assess the use of CHANTIX for smoking cessation following a heart attack. Chantix vs. placebo will be provided for 12 weeks of therapy, and then we will follow up for 52 weeks. An inclusion criterion is current smoker who is motivated to quit after their Acute Coronary Syndrome. They must be randomized while in the hospital. The major exclusion criterion is previous use of Chantix. For more information contact Linda Franklin, RN,CRC or Pat Keane-Richmond,RN,CCRC at 406-752-7636 .

ODYSSEY: An LDL lowering study utilizing human monoclonal antibodies in conjuction with Lipitor or Crestor to treat recent Myocardial Infarct patients. A 5 year study using a twice monthly injection. Statins provided for the study. Main criteria is an LDL on maximally tolerated statin of >70. Must be randomized within 3 months of index event. For more information, contact Pat Keane-Richmond,RN,CCRC or Linda Franklin, RN,CRC at 406-752-7636. pkeane@krmc.org or lfranklin@krmc.org.

PIONEER: A trial for subjects who are on anticoagulant therapy for Atrial Fibrillation and need to undergo a coronary stent placement. A 3 arm randomization atudy. Rivaroxaban 15mg daily, or Rivaroxaban 2.5mg twice daily or Coumadin with INR monitoring. This is a one year study. Medication, labs and study visits will be provided at no charge. Contact Pat Keane-Richmond, RN, CCRC Clinical Research Nurse Coordinator, pkeane@krmc.org or 752-7636. Linda Franklin, RN,CRC,CPAN Clinicall Research Nurse Coordinator. lfranklin@krmc.org or 257-8992x2230.

GLORIA-AF: A registry for newly diagnosed Atrial Fibrillation patients. If prescribed Pradaxa we will follow their progress for 2 years. If prescribed a different anticoagulant we only submit original AF prescribed anticoagulant data once. Contact Pat Keane-Richmond, RN,CCRC at 406-752-7636 pkeane@krmc.org or Linda Franklin, RN,CRC at 406-257-8992x2230 lfranklin@krmc.org.

CAMELIA: A 5 yr. study for patients with diabetes, obesity or cardiovascular disease who will take a study pill called lorcaserin or placebo for weight loss . These patients will be followed closely for cardiovascular outcomes. Along with routine lab testing, there will be frequent ECHOCARDIOGRAM monitoring and ECG monitoring. Contact Pat Keane-Richmond, RN,CCRC at 406-752-7636 / pkeane@krmc.org or Linda Franklin, RN, CPAN,CRC at 406-257-8992x2230/ lfranklin@krmc.org for more information.

COMPASS: A study looking at stable CAD/CABG or Peripheral Artery Disease patients who no longer need dual anti-platelet therapy. Patients will be randomized to rivaroxaban with /without aspirin, rivaroxaban with our without pantoprazole, aspirin with/without rivaroxaban or pantoprazole. This is a 4 year study. For more information contact Pat Keane-Richmond, RN,CCRC at 406-752-7636 or Linda Franklin,RN,CPAN,CRC 406-257-8992x2230.

What current endocrinology clinical trials are available through Glacier View Research Institute? 

Diabetes -Type II

Declare
 - The purpose of the DECLARE study is to look at the impact of an investigational drug dapagliflozin on the incidence of cardiovascular disease (heart attacks and ischemic stroke) in patients with Type 2 Diabetes when compared to placebo..
You may be eligible to take part in this study if:
• You are 40 years of age or older
• You have been diagnosed with type 2 diabetes
• You have a recent HbA1c between 7-12%
• You have existing cardiovascular disease or high risk for cardiovascular event  

Carmelina - The purpose of the CARMELINA study is to look at the impact of an investigational drug called linagliptin on the long-term occurrence of cardiovascular and Renal Microvascular disease in patients with type 2 diabetes when compared to placebo.
You may be eligible to take part in this study if:
• You are 18 years of age or older
• You have been diagnosed with type 2 diabetes
• You have been receiving a stable does of antidiabetic medication for at least 8 weeks or have not ever received any antidiabetic treatment
• You have previously had problems with your heart (cardiovascular disease) and/or kidneys (renal disease) 

Devote - The purpose of the DEVOTE study is to compare the cardiovascular safety of insulin degludec versus insulin glargine in patients with type 2 diabetes at high risk for cardiovascular events.
You may be eligible to take part in this study if:
• You are 50 years of age or older
• You have been diagnosed with type 2 diabetes
• You have a recent HbA1c greater than 7.0% (unless current insulin is greater than 20 u/day)
• Current treatment with one or more oral or injectable antidiabetic agent
• You have had previous problems with your heart (cardiovascular disease) and or/kidneys (renal disease)

Elixa (active but not enrolling) - The purpose of the ELIXA study is to evauluate cardiovascular outcomes in patients with T2DM after acute coronary syndrome during treatment With Lixisenatide.

Lixilan - The purpose of the Lixilan study is to compare efficacy and safety of insulin glargine/lixisenatide combination to insulin glargine in patients with type 2 diabetes.
You may be eligible to take part in this study if:
• You are 18 years of age or older
• You have been diagnosed with type 2 diabetes for at least 1 year
• You have been treated with a basal, long acting, insulin for at least 6 months
• You have a recent HbA1c between 7.5%-10% 

Rewind (active but not enrolling) - The purpose of the REWIND study is to evaluate the Effect of Dulaglutide on major cardiovascular events in patients With T2DM

Themis - The purpose of the THEMIS study is to compare the effect of long-term treatment with ticagrelor vs. placebo for the prevention of major cardiovascular events in patients with Type 2 Diabetes Mellitus at high risk of CV events, but without a medical history of previous MI or stroke.

You may be eligible to take part in this study if:
• You are 50 years of age or older
• Diagnosed with Type II diabetes at least 6 months ago
• High risk for cardiovascular events but with a history of heart attack or stroke.



High Cholesterol and Cardiovascular or Peripheral Artery Disease

Fourier - The goal of the FOURIER study is to find out if the investigational medication may reduce the risk of cardiovascular events in people who have experienced a prior heart attack, stroke or peripheral arterial disease, when compared to placebo.
You may be eligible to take part in this study if:
• You are 40-80 years of age
• You have had a heart attack, ischemic stroke, and/or peripheral artery disease
• You have an LDL greater than 70



For questions please contact:
Laura Ward, RN, CCRC
Glacier View Research-Endocrinology
Phone: (406) 751-4171
Fax: (406) 751-0092
E-mail: lward@krmc.org
or
Magen Lefkowicz
Phone:  (406) 751-5309
E-mail: mlefkowicz@krmc.org  

What current neuroscience and outreach clinical trials are available through Glacier View Research Institute? 

Outreach Clinical Trial:

Chronic Pain Study Using Spinal Cord Stimulation Device
Success Using Neuromodulation with BURST (SUNBURST) Study
The Prodigy implantable pulse generator (also known as a spinal cord stimulator device) delivers either a traditional single stimulation or a new multi-stimulation electrical stimulation to patients. This study aims to evaluate the safety and effectiveness of the Prodigy neurostimulation system using Tonic and Burst stimulation.
Indications: For patients who have chronic intractable pain of the trunk (torso, upper chest and abdomen) and/or limbs (arms and legs). Enrolling since 2013.
Inclusion Criteria: Provide consent for study and cooperate with study requirements, age 22 years old or older, patient has attempted “best” medical therapy and medication treatment regimen and has multiple failed treatments.
Exclusion Criteria: Patient is participating in another clinical trial, previous neurostimulation device implantation, currently seeking, receiving, or applying for disability, workers compensation or involved in disability litigation, existing medical condition that requires an MRI (epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor), peripheral vascular disease, immune-compromised, allergic to titanium or silicone, or documented history of substance abuse (narcotics, alcohol, etc.).

Contact Nichole Marksbury, RN, Clinical Research Nurse Coordinator
Glacier View Research Institute – Neuroscience & Outreach
Phone (406) 755-1460
Fax (406) 155-1462
Email: nmarksbury@krmc.org

What current rheumatology clinical trials are available through Glacier View Research Institute? 

HGS1006-C1113 Systemic Lupus Erythematosus (SLE) Study: A randomized, double-blind, placebo controlled, 52 week study to assess adverse events of special interest in adults with active, autoantibody positive (+) Systemic Lupus Erythematosus receiving Belimumab.
Main Inclusion Criteria:age ≥18 years; on a SLE treatment consisting of any of the following medication (alone or in combination): Corticosteroids, immunomodulatory agents and/or anti-malarials.
Main Exclusion Criteria:received any prior treatment with Belimumab; received treatment with B cell targeted therapy within last year; received any biologic agent other than B cell targeted therapy within 90 days; history of malignant neoplasm within last 5 years; HIV, Hep B or Hep C.

For questions contact:
Glacier View Research Institute-Rheumatology, located at 195 Commons Loop, Suite F, Kalispell, MT 59901
Phone: 406-755-1460
Fax: 406-755-1462
Email: Shawn Erickson, CRC at shawnerickson@krmc.org

 

Celgene CC-10004-PSA-006: A phase 3B, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of Apremilast (CC-10004) monotherapy in subjects with active Psoriatic Arthritis.
Main Inclusion Criteria:age ≥ 18 years of age, documented history of PsA of ≥ 3 months, must be receiving treatment on an outpatient basis, be TNF and Biologic naive and no prior treatment with more than 1 non-biologic DMARD.
Main Exclusion Criteria:history of a rheumatic autoimmune disease other than PsA, history of an inflammatory joint disease other than PsA, current inflammatory joint disease other than RA, history of malignancy in last 5 years, history of Hep B/ Hep C/ TB/ HIV, history of drug/alcohol abuse, history of bacterial, viral or fungal infection within past 4 weeks.

For questions contact:
Glacier View Research Institute-Rheumatology, located at 195 Commons Loop, Suite F, Kalispell, MT 59901
Phone: 406-755-1460
Fax: 406-755-1462
Email: Shawn Erickson, CRC at shawnerickson@krmc.org


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