PI: Dr. Gary Lewis

Sponsor: Monopar Therapeutics 

This study is being performed to evaluate the effectiveness of a new drug, clonidine HCl MBT, to prevent the onset of severe oral mucositis (SOM) in patients with oropharyngeal cancer (OPC) who are being treated with chemoradiotherapy. OPC occurs on the back of the tongue or throat and is often treated by the use of chemoradiotherapy, where radiation is localized to these areas. Radiation to the OPC affected tissues causes the release of small proteins called cytokines that cause damage to the area surrounding the tumor including the oral cavity.

This damage is characterized by the formation of mucositis which includes redness, pain and ulcers in the mouth and back of the throat. OPC survivors who have successful treatment of their tumors often develop permanent swallowing, speaking and range of motion issues that may be linked back to the inability to eat and/or drink caused by SOM during their chemoradiotherapy treatment. Clonidine may inhibit the production of cytokines that cause SOM and clonidine HCl mucoadhesive buccal tablet (MBT) has been designed to deliver sustained high levels of clonidine in the oral cavity, potentially decreasing cytokine production and leading to a decrease in the incidence of SOM. Clonidine HCl MBT is a once per day treatment provided as a tablet that a patient may self-administer to the gums, where it sticks tightly to release clonidine over many hours. The primary objective of this Phase 2b/3 study is to evaluate whether clonidine HCl MBT is more effective than placebo MBT in decreasing the incidence of SOM.

For more information call 501-686-8288 or email CancerClinicalTrials@uams.edu

The Winthrop P. Rockefeller Cancer Institute is enrolling patients in its newly established Phase 1 Cancer Clinical Trials Unit. We’ve recently opened a novel clinical trial sponsored by Jounce Therapeutics, titled: “Phase 1 First-in-Human (FIH) Study of Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2) Inhibitor Monoclonal Antibody (mAb) JTX-8064, as Monotherapy and in Combination with a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, in Adult Subjects with Advanced Refractory Solid Tumor Malignancies.”

Led by Michael Birrer, M.D., Ph.D., Cancer Institute director, this study will bring a novel approach of harnessing the body’s immune system to treat cancer patients who have failed multiple lines of chemo and immunotherapies. The Cancer Institute is currently enrolling ovarian, breast, lung, and head and neck cancer patients to benefit future treatment options. Questions? mrkovak@uams.edu.

S1914: A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC. 

UAMS is a top accruing site for this national study comparing treatments for high-risk, early-stage non-small cell lung cancer (NSCLC). This study is testing whether stereotactic body radiotherapy (SBRT) plus the immune checkpoint inhibitor atezolizumab is better than the standard treatment of SBRT alone. Other trials have shown that a checkpoint inhibitor can benefit people with NSCLC. There is evidence that checkpoint inhibitors are safe and work well when given with radiation treatments. This study will further test this in people with medically inoperable, high-risk, early-stage non-small cell lung cancer. 

Principal Investigator: Sanjay Maraboyina, M.D.

The UAMS Winthrop P. Rockefeller Cancer Institute is participating in the National Cancer Institute’s TMIST (Tomosynthesis Mammographic Imaging Screening Trial).

The study compares two standard breast cancer screening methods: tomosynthesis (3D) mammograms and digital (2D) mammograms, and is designed to help researchers determine whether one method is better than the other at finding life-threatening breast cancers.

The study involves 100 clinics and includes 165,000 women in the United States and Canada. The UAMS Breast Center has enrolled 290 participants to date and is able to include even more women.

“By participating in this research study, you can help determine the most effective type of mammogram and how often women should receive screening,” said Gwendolyn Bryant-Smith, M.D., chief of breast imaging at UAMS and local principal investigator for the trial.

In a briefing held Oct. 7, NCI leaders stated, “We need women to take part to make sure breast cancer screening of the future is appropriate for all women. October is Breast Cancer Awareness Month, a time to share the importance of screening mammograms and early detection.”

The UAMS TMIST study coordinator is available at (501) 400-3195 or TMISTstudy@uams.edu for anyone wanting to learn more about the study.

Women ages 45 to 74 who plan to get a routine screening mammogram at the UAMS Breast Center are eligible for this trial. Participants are randomly assigned to get either a 3D or 2D mammogram every one or two years for the first five years of the study. Researchers will follow each woman’s breast cancer status for a total of eight years by reviewing medical records and possibly conducting phone interviews.

TMIST was developed by the Eastern Cooperative Oncology Group and the American College of Radiology Imaging Network (ECOG-ACRIN) Cancer Research Group and the National Cancer Institute, part of the National Institutes of Health. ECOG-ACRIN leads the trial.