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  1. University of Arkansas for Medical Sciences
  2. Winthrop P. Rockefeller Cancer Institute
  3. Magazine
  4. 2022-2023
  5. Clinical Trials

Clinical Trials

UAMS is Top Enroller in NCI’s Breast Cancer Screening Trial

Modeling the new Breast Center robes are Director Gwendolyn Bryant-Smith, M.D.; myeloma survivor Stuart Cobb; Board of Advisors President Natalie Rockefeller; and friends, Barbara Hoover, and her mother, Josephine Raye Rogers (seated). 

UAMS is ranked in the top 25% of participating clinics.

The Winthrop P. Rockefeller Cancer Institute is a top participant in the National Cancer Institute’s TMIST (Tomosynthesis Mammographic Imaging Screening Trial). The study, which continues through 2027, 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.

Led by the Cancer Institute’s Breast Center Director Gwendolyn Bryant-Smith, M.D., UAMS is ranked in the top 25% of participating clinics. Currently, the study includes 62,855 participants. The UAMS Breast Center has enrolled 354 participants to date and plans to continue enrolling through 2027 or until the study’s goal of 130,000 is met. UAMS has participated in the study since September 2019. 

The trial is open to women ages 45 to 74 who plan to get a routine screening mammogram at the UAMS Breast Center. 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 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.

To learn more about the study,  Call the Cancer Institute’s TMIST line  501-400-3195 or email us at TMISTstudy@uams.edu.

Filed Under: Clinical Trials

Researchers fight Myeloma 

Carolina Schinke, M.D.

Clinical Trial for Drug to Battle Myeloma Underway at the UAMS Myeloma Center

Carolina Schinke, M.D., is leading a clinical trial at the University of Arkansas for Medical Sciences (UAMS) Myeloma Center to study the effectiveness of a new myeloma-fighting drug, talquetamab. 

The trial is titled “A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma.” Through it, researchers will study the response rates to talquetamab, a bispecific antibody. Schinke and other researchers are studying how effective the drug is, what the response rates are and how long they last. 

Bispecific antibodies like talquetamab act as connectors, collecting and binding a myeloma cell with a specific marker to one side and a T-cell to the other, bringing the two together so the T-cell become highly activated and kill the myeloma cell. The specific marker on the myeloma cells that talquetamab targets is called GPRC5D. 

Eight patients at the Myeloma Center, part of the Winthrop P. Rockefeller Cancer Institute, are currently taking part in the trial and receiving treatments every other week, while another four are in the process of enrolling. The international phase II trial, held at UAMS and other locations around the U.S. and in Europe, will have 60 patients enrolled in it. 

Like the new CAR T-cell therapy treatment, talquetamab is best suited for relapsed patients who have exhausted all of their previously available treatment options and whose disease has progressed despite having been through at least three treatment lines.

“With the CAR T-cell treatment, we only have one company so far that’s been approved to offer it, it’s not easy get and the T-cells need to be collected and genetically manipulated, so the patient has to wait six weeks before they can even begin treatment,” Schinke said. “Those who are in dire need can’t wait that long.”

“There are other bispecific antibodies in clinical trials, but they target other markers, including BCMA on myeloma cells,” Schinke said. This is the first antibody targeting GPRC5D.

So far, about 70% to 80% of the patients are responding well to talquetamab, and the drug’s side effects appear to be mild. Those side effects may include a cytokine release syndrome in particular during early injections, low blood counts and potential damage to normal cells that produce GPRC5D, such as hair follicles and fingernails.

“All the patients we’ve enrolled have had a response, but early trial data has shown that this is unfortunately not going to be a cure,” Schinke said. “It’s just a matter of seeing how long it will last.

“All of the patients in the trial will be followed until their disease progresses. While talquetamab is the sole treatment in this clinical trial, efforts to combine it with other drugs in the future are already underway,” Schinke said. 

Filed Under: Clinical Trials

Clinical Trials Office Grows in Preparation for NCI Designation

The 65-person Clinical Trials Team at the Winthrop P. Rockefeller Cancer Institute oversees approximately 260 active clinical studies, averaging 500 participants across 12 cancer types annually. 

Trials include Phase 1 interventional treatment trials, NCI cooperative group studies and multiple investigator initiated trials. 

Investigators have access to a dedicated Phase 1 Infusion Center, disease specific nursing and clinical research coordinator teams and an administrative team made up of regulatory specialists and financial analysts.

In the last year, the team has doubled in size, adding new employees across all teams and an organizational structure consistent with NCI Designated cancer centers.
“We have more than doubled our industry sponsored portfolio while balancing our cooperative group and investigator initiated studies,” said Director Matt Kovak, M.S., CCRP.

“We’re planning for exponential growth. As we diversify and expand our portfolio, we will expand trials across the entire state of Arkansas. Our goal is to provide clinical trials to rural and underrepresented areas across the state.”

Matthew Kovak
Matt Kovak, M.S., CCRP
Director, Cancer Clinical Trials Office
Email: cancerclinicaltrials@uams.edu

High enrolling studies

260 active clinical studies averaging 500 participants across 12 cancer
types annually.

NRG-GY006

A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, or Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer. This trial, led by Heather Williams, M.D., compares any good or bad effects of adding Triapine to the usual cisplatin chemotherapy and radiation therapy, compared to using cisplatin chemotherapy and radiation therapy alone.

S1914

A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT versus SBRT Alone in High Risk, Early Stage NSCLC. This trial, led by Sanjay Maraboyina, M.D., compares overall survival in patients with inoperable non-small cell lung cancer with both radiation and atezolizumab versus radiation alone.

NRG HN006

Randomized Phase II/III
Trial of Sentinel Lymph Node Biopsy versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer. This trial, led by Emre Vural, M.D., looks at the effects of neck and shoulder function zand discomfort compared between sentinel lymph node biopsy or the usual surgery for this type of cancer. 

LUNGMAP

A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study). This study, led by Konstantinos Arnaoutakis, M.D., is being conducted to find out if targeted or immunotherapy treatment will have an effect on specific genes and proteins in the tumor.

Filed Under: Clinical Trials

Winthrop P. Rockefeller Cancer Institute LogoWinthrop P. Rockefeller Cancer InstituteWinthrop P. Rockefeller Cancer Institute
Address: 449 Jack Stephens Dr., Little Rock, AR 72205
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