Clinical Trials

For more information on active clinical trials, please check the Academic Health Center Website at www.ahc.umn.edu/trials or the Fairview Health Services Website at www.fairview.org/research/

All clinical trials involving 1) drugs or biologics or 2) medical devices by law must now be registered in ClinicalTrials.gov. For applicable clinical trials, see ClinicalTrials.gov for more detailed information regarding a study of interest below.

By Program Areas:

Asthma & Allergy

Studying Acid Reflux and Asthma (SARA Study)

Prinicipal Investigator: Malcolm Blumenthal, M.D.
Status: Enrollment complete (Data Analysis Phase)
Contact: 612-626-4031 for more information

People with asthma often have what is called "silent acid reflux" which can make their asthma worse.  The purpose of this study is to see if treating asthmatics for silent acid reflux will improve their asthma.  You may be eligible to participate if 1) you have asthma 2) you take a daily inhaled steroid such as Advair 3) you still have asthma symptoms 4) you do not take acid reflux medication and 5) you do not smoke.  The study involves taking a pill that treats acid reflux 2X each day, 9 visits over 6-8 months, test for acid reflux, and lung function testing.  Participants are compensated up to $600.

Studying Acid Reflux in Children with Asthma (SARCA Study)

Prinicipal Investigator: Malcolm Blumenthal, M.D.
Status: Enrolling
Contact: Sheila Kelleher, 612-626-4724, kell0339@umn.edu

People with asthma often have what is called "silent acid reflux" which can make their asthma worse.  The purpose of this study is to see if treating children with asthma for silent acid reflux will improve their asthma.  You may be eligible to participate if 1) you have asthma 2) you take a daily inhaled steroid such as Advair 3) you still have asthma symptoms 4) you do not take acid reflux medication and .  The study involves taking a pill that treats acid reflux once each day, 10 visits over 6-8 months, test for acid reflux, and lung function testing.  Participants are compensated up to $600.

Chronic Obstructive Pulmonary Disease

Complementary Therapies (Lung Health/Disease Management)

Cystic Fibrosis

Diabetes Therapy to Improve Body Mass Index (BMI) and Lung Function in Cystic Fibrosis (CF)

Principal Investigator: Antoninette Moran, M.D.
Status: TBD
Contact: Patricia Grover, RN, CCRC, grove026@umn.edu or 612-624-0135

The primary objective of this research is to determine whether treatment with either insulin or an oral diabetes agent that increases endogenous insulin secretion will improve body mass index (BMI) and pulmonary function in cystic fibrosis patients who have diabetes without fasting hyperglycemia.

Intensive Insulin Therapy in the Hospitalized CF Patient: A Pilot Study

Principal Investigator: Antoninette Moran, M.D.
Status: TBD
Contact: Patricia Grover, RN, CCRC, grove026@umn.edu or 612-624-0135

The hypothesis in this study is that pulmonary function, weight, protein breakdown and inflammation will show greater improvement over the course of 7 days in hospitalized CF patients treated intensively with insulin therapy.  This pilot study will inlcude 20 CF patients age 12 and older hospitlaized for acute pulmoanry exacerbation and experiencing high blood glucose levels.  This study will help to determine how many patients will be needed for a larger study to prove the hypothesis, how willing patients are to participate, and to refine the protocol as needed before conducting a larger clinical trial.

Environmental/Occupational Health

Interstitial Lung Disease/Pulmonary Fibrosis

Lung Cancer

Phase II Clinical Study of Weekly Topotecan in Combination with Bevacizumab in Patients with Stage IIIB/IV Non-small Cell Lung Cancer Who Have Failed Prior Systemic Chemotherapy

Principal Investigator: Arkadiusz Dudek, M.D.
Status:
Contact: Gerri Anderson, ander258@umn.edu

A Randomized Phase 3 Trial of Pemetrexel and Carboplatin Versus Etoposide and Carboplatin in Extensive-State Samll Cell Lung Cancer

Principal Investigator: Arkadiusz Dudek, M.D.
Status:
Contact: Katie Mellskog, mells003@umn.edu

A Phase III, Randomized, Double-blind, Placebo-controlled Trial of Oral Suberoylanilide Hydroxamic Acid in Patients with Advanced Malignant Pleural Mesothelioma Previously Treated with Systemic Chemotherapy

Principal Investigator: Arkadiusz Dudek, M.D.
Status:
Contact: Anne-Michelle Bakritzes, bakri001@umn.edu

Dose-escalating Study of Biweekly Carboplatin and Gemcitabine in Patients with Advanced Lung Cancer

Principal Investigator: Arkadiusz Dudek, M.D.
Status: ????
Contact: Anne-Michelle Bakritzes, bakri001@umn.edu

Phase II Trial of Neoadjuvant Therapy with Carboplatin and Gemcitabine with Thalidomide in Patients with Stage II and IIIA Non-small Cell Lung Cancer

Principal Investigator: Arkadiusz Dudek, M.D.
Status: ???
Contact: Marva Bohen, info@cancer.umn.edu

A Phase II Study of Triapine in Combination with Gemcitabine in Patients with Metastatic Non-small Cell Lung Cancer

Principal Investigator: Arkadiusz Dudek, M.D.
Status:
Contact: Melissa Steger, stege008@umn.edu

A Phase III, Multicenter, Placebo-controlled, Double-blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination with Tarceva (Erlotinib) Compared with Tarceva Alone for Treatment of Advanced Non-small Cell Lung Cancer after Failure of Standard First-Line Chemotherapy

Principal Investigator: Arkadiusz Dudek, M.D.
Status:
Contact: Gerri Anderson, ander258@umn.edi

A Phase I Study Evaluating Bronchial Artery Infusion of Gemcitabine in Recurrent or Progressive Non-Small Lung Cancer

Principal Investigator: Michael Maddaus, M.D.
Status:
Contact: Katie Mellskog, mells003@umn.edu

A Phase III, Double-blinded, Placebo-controlled Study of Maintenance Pemetrexel Plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment for Advanced Non-small Cell Lung Cancer

Principal Investigator: Robert Kratzke, M.D.
Status:
Contact: Marva Bohen, info@cancer.umn.edu

A Phase II/III Randomized Trial of Two Doses (Phase III-Standard vs High) and Two High Dose Schedules (Phase II-Once vs Twice Daily) for Delivering Prophylatic Cranial Irradiation for Patients with Limited Disease Small Cell Lung Cancer

Principal Investigator: Chung Kyu Lee, M.D.
Status:
Contact: Diane Mosel, dmosel@umphysicians.umn.edu

Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-small Cell Lung Cancer

Principal Investigator: Bruce Peterson, M.D.
Status:
Contact: Laura Maybon, maybo001@umn.edu

Cisplatin, Irinotecan and Bevacizumab for Untreated Extensive Stage Small Cell Lung Cancer: A Phase II Study

Principal Investigator: Bruce Peterson, M.D.
Status: ??
Contact: Laura Maybon, maybo001@umn.edu

A Phase II Randomized Study of OSI-774 (Erlotinib) With or Without Carboplatin/Paclitaxel in Patients with Previously Untreated Adenocarcinoma of the Lung Who Never Smoked or Were Former Light Smokers

Principal Investigator: Bruce Peterson, M.D.
Status: ??
Contact: Laura Maybon, maybo001@umn.edu

Lung Transplantation

Pulmonary Hypertension

Respiratory Failure/Critical Care

Sleep Medicine

Tobacco Cessation

Timing of Smoking Intervention in Alcohol Treatment

Prinicipal Investigator: Anne Joseph, M.D.
Status: Active, enrollment complete
Contact:

Study of Use of Nicotine Gum

Principal Investigator: Marc Mooney, M.A.
Status: Active, enrollment complete
Contact:

Bupropion + Placebo or Bupropion + Naltrexone for Smoking Cessation

Principal Investigator: Marc Mooney, M.A.
Status: Enrolling patients
Contact: 612627-4900

The University of Minnesota's Tobacco Use Research Center is conducting a research study to evaluate an investigational drug, to be used with Zyban, on smoking cessation for smokers in good health. 

Treatment of Smokeless Tobacco Users Comparison Across Treatment Conditions

Principal Investigator: Dorothy Hatsukami, Ph.D.
Status: Enrolling patients
Contact:

This research study is designed to assess the the use of behavioral counseling and a product to help control tobacco use.   Eligible and consenting individuals will be required to attend 6-7 visits and one phone call over 6-7 months.  At each 30-minute appointment, blood pressure, pulse and weight is taken along with collection of urine.  Several questionnaires will need to be completed.  Participants receive $25 for their participation.