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Kalispell Regional Healthcare
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? 

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

Miraca-Hemotologic Disorders: enrolling
“A Registry of Hematopoietic Diseases for Evaluation of Correlation with Clinical Outcomes”

Bolero-Breast Cancer-enrolling
A three-arm, randomized, open label, phase II studyu of everolimus in combination wit exemestane versus everolimus alone versus capecitabine in the treatment of postmenopausal women with estrogen receptor positive, locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on prior letrozole or anastrozole

Berenice-Early Breast Cancer-starting September 2014
A multicenter multination, Phase II study to evaluate Pertuzumab in combination with Trastuzumab and standard neoadjuvant Anthracycline-Based Chemotherapy in patients with HER2-Positive Locally advanced inflammatory or early-stage Breast Cancer.

CABS-Breast (Early Stage)-enrolliong
Prospective Study of the relationship between Chemotherapy Dose Intensity and Mortality in Early-Stage (1-III) Breast Cancer Patients

JANUS 1-Pancreatic-Due to start October/November 2014
A Randomized, Double-Blind, Phase 3 Study of the JAK ½ Inhibitor, Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy

Montana Cancer Consortium Studies
BRAIN
High-Grade
Cancer Control CTSU A221101 
A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil
(Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma
NCCTG N0577 
Phase III Intergroup Study of Radiotherapy versus Temozolomide alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma 
RTOG R0834 
Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1P/19Q Deleted Anaplastic Glioma: the CATNON Intergroup Trial
Low-Grade
Cancer Control RTOG R0925 
Natural History of Postoperative Cognitive Function, Quality of Life, and Seizure Control 
in Patients with Supratentorial Low-risk Grade II Glioma 
Recurrent
NRG R1205 Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma 
Alliance A071101 
A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein-Peptide Complex-96 (HSPPC-96) Vaccine Given with Bevacizumab vs Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme (GBM)
Alliance N1174 
Phase I/ Comparative Randomized Phase II Trial of TRC105 plus Bevacizumab versus Bevacizumab in Bevacizumab-Naïve Patients with Recurrent Glioblastoma Multiforme

Brain Mets
Alliance N107C 
A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease

BREAST
Cancer Control CTSU A011104 
Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life 
CTSU SCUSF0806 (Non-anthracycline arm closed 2/5/14) (pending closure - call for enrollment slot prior to consenting patient) 
Phase II Placebo-controlled Trial of Lisinopril and Coreg CR to Reduce Cardiotoxicity in 
Patients with Breast Cancer Receiving (neo)adjuvant Chemotherapy with Herceptin 

Breast - Other 
SWOG S0812 (Pending permanent closure) (Partial Closure effective 04/07/14-Open only to pts who consent to Breast BX) 
A Randomized Double-Blind Placebo-Controlled Biomarker Modulation Study of High Dose Vitamin D in Premenopausal Women at High-risk for Breast Cancer, Phase IIB 
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
NRG B-51 
A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chest Wall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
Cancer Control CTSU ACOSOG Z11102 
Impact of Breast Conservation Surgery on Surgical Outcomes and 
Cosmesis in Patients with Multiple Ipsilateral Breast Cancer (MIBC) 

Breast DCIS 
NSABP B43 
A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy 
CTSU C40903 
Phase II Study of Neoadjuvant Letrozole for Post-menopausal Women with Estrogen Receptor Positive Ductal Carcinoma in Situ (DCIS)

Breast - Node Negative
Breast - Node Positive or Negative
NSABP B47 
A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High Risk Node-Negative HER2-low Invasive Breast Cancer
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
CTSU A011106 
ALTernate approaches for clinical stage II or III Estrogen Receptor positive breast cancer NeoAdjuvant Treatment (ALTERNATE) in postmenopausal women: a phase III study

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
NSABP B52 
A Randomized Phase III Trial Evaluating Pathologic Complete Response Rates in Patients with Hormone Receptor Positive, HER2-Positive, Large Operable and Locally Advanced Breast Cancer Treated with Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab with or without Estrogen Deprivation

Neo Adjuvant
NSABP B-51 
A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chest Wall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

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

Breast - Inflammatory
Breast - Regional Relapse
Breast - Metastatic
Cancer Control SWOG S1202 
A Placebo-controlled Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated
Musculoskeletal Symptoms in Women with Early Stage Breast Cancer
CTSU A221102 
Placebo-Controlled Study of Subcutaneous Testosterone in the Adjuvant Treatment of
Postmenopausal Women with Aromatase Inhibitor Induced Arthralgias 
ECOG-ACRIN E3108 
A Phase II Prospective Trial Correlating Progression Free Survival with CYP2D6 Activity in Patients with Metastatic Breast Cancer Treated with Single Agent Tamoxifen 
CTSU E2108 
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer 
SWOG S1222 
Fulvestrant Alone Versus Fulvestrant and Everolimus Versus Fulvestrant, Everolimus and Anastrozole: A Phase III Randomized Placebo-Controlled Trial in Postmenopausal Patients with Hormone-Receptor Positive Stage IV Breast Cancer 
ECOG-ACRIN E2112 
A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Postmenopausal Patients with Hormone Receptor-Positive Advanced Breast Cancer 
ACCRU RU0112011 
A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First- or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer

GASTROINTESTINAL
Colon - Rectal 
Cancer Control SWOG S0820 Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)

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
Stage II Colon
Stage III Colon
CTSU C80702 
A Phase III Trial of 6 vs 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer 

Metastatic Colon
Small Bowel
Rectal
NCCTG N1048 
A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision

Stomach
SWOG S1201 
A Randomized Phase II Pilot Study Prospectively Evaluating Treatment for Patients Based on ERCC1 (Excision Repair Cross-Complementing 1) for Advanced/Metastatic Esophageal, Gastric, or Gastroesophageal Junction (GEJ) Cancer

Esophageal
SWOG S1201 
A Randomized Phase II Pilot Study Prospectively Evaluating Treatment for Patients Based on ERCC1 (Excision Repair Cross-Complementing 1) for Advanced/Metastatic Esophageal, Gastric, or Gastroesophageal Junction (GEJ) Cancer
RTOG R1010 
A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma 
CTSU C80803 
Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer 

Pancreas 
RTOG R1201 
A Phase II Randomized Trial of High versus Standard Intensity Local or Systemic Therapy for Unresectable Pancreatic Cancer 
NRG R0848 
A Phase IIR and a Phase III Trial Evaluating Both Erlotinib (PH IIR) and Chemoradiation PH III) as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma
ECOG-ACRIN E2212 
A Randomized, Double-Blinded, Placebo-Controlled Phase II Study of Adjuvant Everolimus Following the Resection of Metastatic Pancreatic Neuroendocrine Tumors to the Liver.

Liver
ECOG-ACRIN E1208 
A Phase III Randomized Trial of Chemoembolization with or without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients with and without Vascular Invasion 

Gallbladder
SWOG S1310 
Randomized Phase II Trial of Single Agent MEK Inhibitor Trametinib (GSK1120212) Vs 5-Fluorouracil or Capecitabine in Refractory Advanced Biliary Cancer

Stromal
Carcinoid
CTSU A021202 
Prospective Randomized Phase II Trial of Pazopanib vs Placebo in Patients with Progressive Carcinoid Tumors 

Cholangiocarcinoma
GENITOURINARY
CTSU C90601 
Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin and Placebo in Patients with Advanced Transitional Cell Carcinoma 

Prostate-Local 
Cancer Control CTSU C70807 
(MEAL)Study: Diet to Alter Disease Progression in Prostate Cancer Patients on Active 
Surveillance 
CTSU CALGB 90203 
Randomized Phase III Study of Neoadjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy vs Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer
RTOG R0924 
Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial 
RTOG R1115 
Phase III Trial of Dose Escalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) with a GnRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT with a GnRH Agonist and TAK-700 for Men with High Risk Prostate Cancer

Prostate-Recurrent 
RTOG R0534 (QOL/neurocogn closed)
A Phase III Trial Of Short Term Androgen Deprivation With Pelvic Lymph Node Or Prostate Bed Only Radiotherapy (SPORT) In Prostate Cancer Patients With A Rising PSA After Radical Prostatectomy

Prostate-Metastatic
CTSU A031201 
Phase III Trial of Enzalutamide vs Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer 
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

Bladder/Urothelium
CTSU C90601 
Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin and Placebo in Patients with Advanced Transitional Cell Carcinoma 
SWOG S1314 
A Randomized Phase II Study of Co-Expression Extrapolation (COXEN) With Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer 

Germ Cell Malignancies
none

Renal
CTSU A031203 
Randomized Phase II Study Comparing Cabozantinib with Commercially Supplied Sunitinib in Patients with Previously Untreated Locally Advanced or Metastatic Renal Cell Carcinoma
SWOG S0931 
"EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, a Phase III Study 
ECOG-ACRIN E2810 
Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy 

GYNECOLOGIC
Cancer Control CTSU G0225 
Can Diet and Exercise Modulate Ovarian, Fallopian Tube and Primary
Peritoneal Cancer Progression-Free Survival?
GOG G0244 (7/7/14 closed to patients with vulvar cancer)
The Lymphedema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and
Impact in Newly Diagnosed Patients

Ovarian
Cervical
RTOG R1203 
A Randomized Phase III Study of Standard vs IMRT Pelvic Radiation for Post-operative Treatment of Endometrial and Cervical Cancer 
GOG G0274 
A Phase III Trial of Adjuvant Chemotherapy as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The Outback Trial 

Endometrial
RTOG R1203 
A Randomized Phase III Study of Standard vs IMRT Pelvic Radiation for Post-operative Treatment of Endometrial and Cervical Cancer 

Uterine
CTSU G0238 
A Randomized Trial of Pelvic Irradiation with or Without Concurrent Weekly Cisplatin in Patients with Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus 
CTSU G0277 
A Phase III Randomized Trial of Gemcitabine plus Docetaxel followed by Doxorubicin versus Observation for Uterus-Limited, High-Grade Uterine Leiomyosarcoma 
CTSU G0275 
A Phase III Randomized Trial of Pulse Actinomycin-D vs Multi-day Methotrexate for the Treatment of Low-risk Gestational Trophoblastic Neoplasia 

HEAD & NECK
CTSU E1311 
A Randomized, Placebo Controlled Phase II Trial of Afatinib (BIBW2992) as Adjuvant Therapy Following Chemoradiation in Patients with Head and Neck Squamous Cell Carcinoma at High Risk of Recurrence 
CTSU E1305 
A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer
NRG R0920 
A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer

LEUKEMIA
Acute Myelogenous Leukemia
SWOG S0919 
Phase II Study of Idarubicin and Ara-C in Combination with Pravastatin for Poor-Risk Acute Myelogenous Leukemia (AML) 
ECOG-ACRIN E2906 
Phase III Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin & Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age ≥60 Years) 
SWOG S1203 
A Randomized Phase III Study of Standard Cytarabine Plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (NSC-701852) (IA + V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)

Maintenance
Myelodysplastic Syndrome
ECOG-ACRIN E2905 
Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide (Revlimid) Alone and in Combination with Epoetin Alfa (Procrit) in Subjects with Low- or Intermediate-1 Risk MDS and Symptomatic Anemia 
SWOG S1117 (temporary closure 4/15/14) 
A Randomized Phase II Study of Azacitidine in Combination with Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML) 

Lymphoblastic Leukemia
ECOG-ACRIN E1910 
A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL negative B lineage Acute Lymphoblastic Leukemia in Adults

Chronic Leukemia
Alliance A041202 
A Randomized Phase III Study of Bendamustine Plus Rituximab vs Ibrutinib Plus Rituximab vs Ibrutinib Alone in Untreated Older Patients (> 65 years of age) with Chronic Lymphocytic Leukemia (CLL)
SWOG S1117 (temporary closure 4/15/14)
A Randomized Phase II Study of Azacitidine in Combination with Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
ECOG-ACRIN E1912 
A Randomized Phase III Study of Ibrutinib-based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab Chemoimmunotherapy in Untreated Younger Patients with CLL

LUNG 
Non-Small Cell
Local
Adjuvant
RTOG R1306 (temporary closure 8/27/14)
A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-Small Cell Lung Cancer (NSCLC)
Advanced
SWOG S0819 (temporary closure 6/1/14) 
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) 
SWOG S0709 (temporary closure 3/20/13) 
Phase II Selection Design of Pharmacodynamic Separation of Carboplatin/Paclitaxel/Erlotinib or Erlotinib Alone in Advanced NSCLC Patients with Performance Status 2 Selected by Serum Proteomics 
CTSU E5508 
Randomized Phase III Study of Maintenance Therapy with Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC 
SWOG S1400 
Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer 
SWOG S1400A 
A Phase II/III Randomized Study of MEDI4736 vs Chemotherapy as 2nd Line Therapy for Patients with Squamous Cell Lung Cancer and No Matching Biomarkers
SWOG S1400B 
A Phase II/III Randomized Study of GDC-0032 Versus Chemotherapy as Second Line Therapy for Biomarker Selected Patients with Squamous Cell Lung Cancer 
SWOG S1400C 
A Phase II/III Randomized Study of Palbociclib Versus Chemotherapy as Second Line Therapy for Biomarker Selected Patients with Squamous Cell Lung Cancer 
SWOG S1400D 
A Phase II/III Randomized Study of AZD4547 Versus Chemotherapy as Second Line Therapy for Biomarker Selected Patients with Squamous Cell Lung Cancer 
SWOG S1400E 
A Phase II/III Randomized Study of Rilotumumab Plus Erlotinib Versus Erlotinib as Second Line Therapy for Biomarker Selected Patients with Squamous Cell Lung Cancer 

Small Cell
CTSU C30610 Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer also receiving Cisplatin and Etoposide
RTOG R0937 
Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED_SCLC)
ECOG ACRIN E2511 
Phase I and Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination with Veliparib (ABT-888) or Placebo as Frontline Therapy for Extensive Stage 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

LYMPHOMA
Hodgkin's
Non-Hodgkin's
SWOG S1001 
A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-Cell Lymphoma
CTSU C50904 
A Randomized Phase II Trial of Ofatumumab and Bendamustine vs. Ofatumumab, Bortezomib and Bendamustine in Patients with Untreated Follicular Lymphoma

B-Cell
ECOG-ACRIN E1412 
Randomized Phase II Open Label Study of Lenalidomide, R-CHOP vs R-CHOP in Patients with Newly Diagnosed Diffuse Large B Cell Lymphoma

T-Cell
Mantle Cell
CTSU E1411 
Intergroup Randomized Phase II Four Arm Study In Patients ? 60 With Previously Treated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation; Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation

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 
CTSU E2607 
A Phase II Trial of Dasatinib in KIT-Positive Patients with Unresectable Locally Advanced or Stage IV Mucosal, Acral and Vulvovaginal Melanomas 
Alliance A091201 
Randomized Phase II Study Comparing the MET inhibitor Cabozantinib to Temozolomide/Dacarbazine in Ocular Melanoma 
SWOG S1320 
A Randomized Phase II Trial of Intermittent Versus Continuous Dosing of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAFV600E/K Mutant Melanoma 

MYELOMA
SWOG S1304 
A Phase II Randomized Study Comparing Two Doses of Carfilzomib with Dexamethasone for Multiple Myeloma Patients with Relapsed or Refractory Disease
ECOG-ACRIN E3A06 
Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma
ECOG-ACRIN E1A11 
Randomized Phase III Trial of Bortezomib, LENalidomide and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide and Dexamethasone (CRd) Followed by Limited or Indefinite DURation Lenalidomide MaintenANCE in Patients with Newly Diagnosed Symptomatic Multiple Myeloma (ENDURANCE)

SARCOMA 
Alliance A091102 (permanent closure cohorts 2,4) (temporary closure cohorts 1, 3, 5) A Phase 2 Study of MLN8237 in Advanced/Metastatic Sarcoma

OTHER 
NRG R0631 (Phase III open) 
Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis

For Questions Contact:
Susan Spears or 
Jaime Wyatt
Phone: 406 752 8900 Ext 231
Fax: 406 752 8909
Cell (Weekends) 928 231 0848
Glacier View Research Institute-Cancer
Northwest Hematology & Oncology
The Rock Medical Office Building
350 Heritage Way Suite 1100
Kalispell, MT 59901

 

 

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

ADVENT-HF: A study to assess the effects of Adaptive Servo Ventilation on survival and frequency of cardiovascular hospital admissions in patients with heart failure and sleep apnea.  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 are HF patients with obstructive or central sleep apnea.  Patients will be screened for sleep apnea if they have HF as determined by echocardiography at screening.  Patients cannot already be using CPAP.  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 a medical procedure. Indications: Patients on warfarin for stroke prophylaxis secondary to Atrial Fibrillation.  Contact Pat Keane-Richmond, RN, CCRC Clinical Research Nurse Coordinator, pkeane@krmc.org.  406-752-7636. 

ODYSSEY: A study utilizing human monoclonal antibodies to lower LDL, along with Lipitor or Crestor to treat recent heart attack patients.  A 5 year study using a twice monthly injection. Lipitor or crestor provided for the study. 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. Subjects will receive Rivaroxaban 15mg daily or Rivaroxaban 2.5mg twice daily or Coumadin with INR monitoring.  Medication, labs and study visits will be provided at no charge. Contact Pat Keane-Richmond, RN, CCRC, pkeane@krmc.org  752-7636 or Linda Franklin, RN, CRC, CPAN lfranklin@krmc.org  257-8992 x2230.

GLORIA-AF: A registry for newly diagnosed Atrial Fibrillation patients.  Contact Pat Keane-Richmond, RN, CCRC at 406-752-7636 pkeane@krmc.org

CAMELIA: A 5 yr. study for patients with diabetes, obesity or cardiovascular disease who may take a study pill called lorcaserin 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 406-257-8992 x2230 lfranklin@krmc.org.

COMPASS: A study looking at stable patients with documented cardiovascular disease that no longer need aspirin and Plavix (like drugs).  Study aspirin, rivaroxaban and protonix are provided. This is a 4 year study. Contact Pat Keane-Richmond, RN, CCRC at 406-752-7636 or Linda Franklin,RN,CPAN,CRC  406-257-8992 x2230.

PARAGON: A study for heart failure patients recently hospitalized for heart failure. First in its class study medication or standard care medication will be provided, along with lab, ECG, Echocardiography, and study visits at no cost. Contact Pat Keane-RichmondRN,CCRC at 406-752-7636  pkeane@krmc.org  or Linda Franklin, RN,CCRC at 406-257-8992 x2230 lfranklin@krmc.org

ADAPT-HF: A study for patients needing new biventricular pacing for heart failure. Patients who need this device will be asked to participate. The device is not provided. We are studying whether a specific program in the device benefits the patients in terms of their heart failure symptoms. Contact Pat Keane-Richmond,RN,CCRC  at 406-752-7636 pkeane@krmc.org or Linda Franklin, RN,CRC at 406-257-8992 lfranklin@krmc.org

REVEAL-AF:. This is a study targeting coronary disease patients with Sleep Apnea. The device will be implanted under local anesthesia. The goal is to identify patients with Paroxysmal Atrial Fibrillation that is not documented. Once it is determined the patients do have this dysrhythmia, anticoagulation therapy may be initiated to prevent embolic stroke. For more information, contact Pat Keane-Richmond,RN,CCRC at pkeane@krmc.org or 406-752-7636.

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

Diabetes -Type II

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) 

Declare (active but not enrolling) - 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.

Devote (active but not enrolling)- 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.

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

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

 



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 lward@krmc.org
Magen Lefkowicz, CRC: mlefkowicz@krmc.org
Glacier View Research-Endocrinology
Phone: (406) 751-4171
Fax: (406) 751-0092

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

Research opportunities relating to stroke, stroke prevention, Multiple Sclerosis,  neuropathic pain and other neurologically-based trials are being actively pursued. 

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

Success Using Neuromodulation with BURST (SUNBURST) Study
A Chronic Pain Study Using Spinal Cord Stimulation Device 
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.).
For questions please contact:

Gretchen Henstorf BA, CCRC, Certified Clinical Research Coordinator
Glacier View Research Institute-Rheumatology, located at 195 Commons Loop, Suite F, Kalispell, MT 59901 
Phone:  406-755-1460
Fax:  406-755-1462
Email:  ghens@krmc.org

A prospective study for chronic lumbar back pain associated with moderate Degenerative Disc Disease is being evaluated.  No date for enrollment of this study is available. For questions, please contact Gretchen Henstorf.

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

HGS1006-C1113 Systemic Lupus Erythematosus (SLE) Study: A study to assess adverse events of special interest in adults with active Systemic Lupus Erythematosus (SLE) while receiving Benlysta (belimumab), which is currently on the market.  We are looking for subjects that are ≥18 years; on an SLE treatment and no prior history of the use of Benlysta.
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.

Pfizer A3921133:  This is a study to evaluate the safety of Xeljanz at 5mg twice daily or 10mg twice daily, compared to Humira 40mg every other week, in subjects with Rheumatoid Arthritis (RA)
Main Inclusion Criteria: Age ≥ 50 years; have moderate to severe RA; have had an inadequate response to methotrexate alone and have certain risk factors for cardiovascular disease.  Subjects must have taken methotrexate continuously for ≥ 4 months prior to screening.
Main Exclusion Criteria: Received any prior treatment with Xeljanz; experienced an inadequate response or intolerance to Humira; history of malignant neoplasm; HIV/HEP B/HEP C.

BI1297.2: This is a study to evaluate the safety and effectiveness of BI 695501 (a possible generic to Humira) vs Humira in patients with active Rheumatoid Arthritis.
Main Inclusion Criteria: 18-80 years of age; have moderate to severe RA; must be taking methotrexate.
Main Exclusion Criteria: No prior treatment with a biologic agent; history of cancer including solid tumors; HIV/HEP B/HEP C; history of juvenile RA.  

Lilly I1F-MC-RHBE: This is a study to evaluate the long-term safety and effectiveness of an investigational drug, ixekizumab (LY2439821), in subjects with psoriatic arthritis (PsA) who have tried a conventional or biologic DMARD in the past.
Main Inclusion Criteria: Age ≥ 18 years; have had a diagnosis of active PsA for at least 6 months with either active or documented psoriatic lesions (plaque), have been treated with one or more cDMARDs, have been treated with at least 1 but not more than 2 TNF inhibitors.
Main Exclusion Criteria: Currently receiving treatment with any biologic or small molecule therapy for PsA or psoriasis, or have received denosumab, history of drug-induced psoriasis, or have diagnosis of other conditions including Crohn's disease, fibromyalgia, vasculitis, HIV/HEP B/HEP C.
 

For questions contact:
Shawn Erickson, CRC, Clinical Research Coordinator
Gretchen Henstorf, BA, CRCC, Clinical Research Coordinator
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, LPN, CRC at shawnerickson@krmc.org or Gretchen Henstorf, BA, CCRC at ghens@krmc.org


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