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Michael LeCompte, M.D.

  • Assistant Professor of Surgery, Division of Surgical Oncology and Endocrine Surgery

Michael LeCompte, M.D.

  • Assistant Professor of Surgery, Division of Surgical Oncology and Endocrine Surgery

michael.t.lecompte@vumc.org

Research Program

Research Description

Have any questions? Contact Us 1-877-936-8422 for more information

Asheley Chapman, Ph.D.

  • Assistant Professor of Chemical and Biomolecular Engineering

Asheley Chapman, Ph.D.

  • Assistant Professor of Chemical and Biomolecular Engineering

asheley.chapman@Vanderbilt.Edu

Research Program

Have any questions? Contact Us 1-877-936-8422 for more information

Wife of cholangiocarcinoma patient makes gift in honor of husband

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Kristen Ciombor, MD, MSCI, left, with Sallie Bailey (courtesy/Sallie Bailey)

When Sallie Bailey’s husband, John Bailey, was diagnosed with cholangiocarcinoma (bile duct cancer) in July 2018, the news came as a shock. Just months earlier, his physical appearance showed no difference.

The first sign was subtle: jaundice in one eye. The jaundice quickly spread throughout John’s entire body, the point at which he and Sallie met with Benjamin Womack, MD, associate professor of Clinical Medicine. Despite the care of Womack, Patrick Yachimski, MD, MPH, professor of Medicine, and Kristen Ciombor, MD, MSCI, associate professor of Medicine, John passed away in November 2018, only four months after his diagnosis.

“Until the jaundice appeared, there were no symptoms,” Sallie recalls. “It’s a silent disease, and by the time it’s detected, it’s often too late.”

John was more than a patient at Vanderbilt-Ingram Cancer Center. He was a man with a passion for good food and wine. A talented chef, he worked in San Francisco, Chicago, France, and Washington, D.C., before retiring from professional kitchens. Even then, he continued creating memorable meals for family and friends and sought out locally owned restaurants and new wines to enjoy. His welcoming smile made everyone feel special, and he loved traveling, especially to California wine country.

After moving to Nashville in 2011, Sallie and John chose Vanderbilt Health for their care because they valued being part of a teaching hospital. That decision connected them to a team of experts who provided compassionate care during an incredibly difficult time. Sallie’s experience inspired her to take action. Today, she supports research led by Ciombor and Yachimski, hoping to help scientists detect cholangiocarcinoma earlier and slow its progression.

“Ultimately, I hope researchers will find a way to treat the cancer so that it isn’t a death sentence,” Sallie says. “Dr. Yachimski and Dr. Ciombor have both told me their goal is to work themselves out of a job. I admire and support that goal.”

Through her gifts, Sallie honors John’s legacy in a deeply meaningful way. Her support helps researchers pursue earlier detection methods, develop treatments that slow disease progression, and improve quality of life for patients. It also fuels innovation in clinical trials and provides hope for families facing rare cancers like cholangiocarcinoma. Every contribution moves science closer to a future where this diagnosis is no longer a death sentence.

“Particularly for a rare tumor type such as cholangiocarcinoma, contributions like Sallie’s propel our understanding of the molecular underpinnings of these tumors forward and set the stage for future therapeutic advances,” Ciombor said. “Philanthropic support such as Sallie’s provides critical resources at a time when patients with cancer need better treatment options more than ever.”

Learn more about supporting cancer research and making a gift by clicking here. When making a gift, please write in the comment field that you’d like your donation to support cholangiocarcinoma initiatives.

The post Wife of cholangiocarcinoma patient makes gift in honor of husband appeared first on Vanderbilt Health.

Denise Garcia, M.D.

  • Assistant Professor of Surgery, Division of Surgical Oncology and Endocrine Surgery

Denise Garcia, M.D.

  • Assistant Professor of Surgery, Division of Surgical Oncology and Endocrine Surgery

di.garcia@vumc.org

Research Program

Research Description

Have any questions? Contact Us 1-877-936-8422 for more information

Matthew Burger, M.D.

  • Instructor in Radiology and Radiological Sciences

Matthew Burger, M.D.

  • Instructor in Radiology and Radiological Sciences

matthew.burger@vumc.org

Research Program

Have any questions? Contact Us 1-877-936-8422 for more information
This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.
NRG-CC015 is a prospective, randomized phase III clinical trial to evaluate the efficacy of two distinct digital approaches for delivering a mindfulness-based intervention: a live, instructor-led version delivered over Zoom (MAPs LO), and an app-based, self-paced version (MAPs App). Participants will include younger breast cancer survivors (BCS) who were diagnosed with breast cancer at or before age 50 years, have completed their primary cancer treatment (i.e., surgery, radiation, and/or chemotherapy) at least 6 months earlier, and report elevated depressive symptoms.

Clinical trial led by Vanderbilt Health seeks to refine lung cancer biopsy standards

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Vanderbilt Health investigators have received a grant from AstraZeneca to lead a multisite, randomized controlled trial aimed at refining the standard of care when using robotic bronchoscopy combined with three-dimensional imaging to obtain lung samples for malignancy assessment and gene sequencing.

“Recent advances in minimally invasive bronchoscopic techniques have improved the diagnostic yield, particularly for peripheral pulmonary lesions, and in the recent VERITAS trial, we demonstrated that navigational bronchoscopy can achieve a diagnostic accuracy of around 79%,” said Fabien Maldonado, MD, MSc, professor of Medicine and Thoracic Surgery and director of Interventional Pulmonology at Vanderbilt Health. “That is statistically comparable to transthoracic needle biopsy, which is around 74% accurate.”

Fabien Maldonado, MD, MSc
Fabien Maldonado, MD, MSc

“Because of the proven success of navigational bronchoscopy, we now want to determine whether or not the rapid, on-site evaluation (ROSE) of biopsy material remains a necessary step. We’ll test the hypothesis that this advanced bronchoscopy procedure done without ROSE guidance is non-inferior to bronchoscopy with ROSE. This could have immediate patient care implications, potentially shortening procedure time, improving specimen quality and avoiding complications from additional, unnecessary biopsies.”

ROSE has been the standard of care for decades in navigational bronchoscopy, but it adds time, cost and may paradoxically result in lower quality specimens. It can also lead to complications from unnecessary biopsies motivated by unclear intraprocedural results. With modern techniques such as robotic bronchoscopy with cone-beam CT technology, which is rapidly becoming the standard of care, the need for ROSE needs to be studied, said Maldonado, who holds the Pierre Massion Directorship in Lung Cancer Research.

The development of better biopsy approaches is driven by the fact that lung cancer kills more than 130,000 Americans annually, and survival depends on early diagnosis, which requires biopsy to be definitive. Current approaches make accurate biopsy challenging or even impossible for many hard-to-reach lesions.

These modern bronchoscopy techniques extend the range of bronchoscopes and the ability to access lesions reliably and safely throughout the lung, including in the peripheral zone, said study co-investigator Rafael Paez, MD, MSCI, assistant professor of Medicine in the Division of Allergy, Pulmonary and Critical Care Medicine.

The Advanced Robotic Techniques and Rapid Onsite Evaluation for Minimally Invasive Diagnosis and Next-Generation Sequencing (ARTEMIS) trial will be conducted at Vanderbilt Health and nine other United States medical centers. Expected enrollment will be 440 adults who are scheduled for a navigational bronchoscopy for the evaluation of a pulmonary lesion. Participants will be randomized to have the procedure with the addition of ROSE or to have the procedure without ROSE.

The primary objective is to assess the diagnostic yield of robotic bronchoscopy with and without ROSE for peripheral lung lesions. A secondary objective is to compare the adequacy of malignant tissue samples for next-generation sequencing (NGS) between the two intervention strategies.

ROSE involves the immediate microscopic assessment of biopsy specimens, typically performed by a cytotechnologist or cytopathologist, to confirm the adequacy of biopsy samples obtained during a bronchoscopy for the diagnosis of malignancy. This has also been an important step in the past to ensure sufficient tissue is obtained for NGS to identify genetic mutations to guide treatment decisions, said Maldonado.

A 2023 Rapid On-site Evaluation Practice Variability Appraisal survey of interventional pulmonologists revealed significant variation in ROSE utilization. Of the 137 respondents, 88% reported ROSE availability, while time constraints (28%), availability of cytology (22%) and scheduling conflicts (20%) were the most reported barriers to ROSE utilization.

“Additional motivation for determining if ROSE use and non-ROSE use yield similar outcomes during diagnostic procedures is that ROSE is historically poorly reimbursed and uses considerable hospital resources,” Maldonado said. “Our findings will guide interventional pulmonologists in optimizing workflow and technology during robotic bronchoscopy, aiming to maintain the nearly 80% diagnostic yield seen in trials like VERITAS, thus improving patient care as we evaluate pulmonary lesions.”

The post Clinical trial led by Vanderbilt Health seeks to refine lung cancer biopsy standards appeared first on Vanderbilt Health.

This study consists of 2 portions. The phase 2 portion is an open-label, single-arm study to evaluate the safety and efficacy of NAI, PD-L1 t-haNK, and bevacizumab combination therapy in participants with recurrent or progressive GBM. The phase 2B portion is an open-label, randomized study to evaluate the efficacy and safety for the following 2 experimental arms in participants with recurrent or progressive GBM: NAI, bevacizumab, and TTFields combination therapy (Arm A) or NAI, PD-L1 t-haNK, bevacizumab, and TTFields combination therapy (Arm B). Phase 2 Treatment for all enrolled participants will consist of repeated cycles of 28 days for a maximum treatment period of 76 weeks (19 cycles) as follows: Every 2 weeks (Days 1 and 15 of a 28-day cycle) Fourteen (14) participants were enrolled in the phase 2 portion of this study as of the date of this v02 protocol. No additional participants will be administered therapy in phase 2. Phase 2B Participants will be randomized 1:1 to 1 of 2 experimental arms (Arm A or Arm B). Treatment for all enrolled participants will consist of repeated 8-week cycles for a maximum treatment period of up to 80 weeks (10 cycles). Experimental Arm (A): Every 2 weeks (Days 1, 15, 29, and 43 of an 8-week cycle) Up to twenty (20) participants will be randomized in phase 2B (up to 10 participants/arm. Duration of Treatment: Participants will receive study treatment for up to 76 weeks during phase 2 (up to 19 repeated 28-day cycles) and for up to 80 weeks (up to 10 repeated 8-week cycles) during phase 2B or until they report unacceptable toxicity (not corrected with dose reduction), withdraw consent, or if the Investigator feels it is no longer in the participant's best interest to continue treatment. Treatment may also be discontinued if the participant has confirmed PD per iRANO, unless the participant is clinically stable and is considered potentially deriving benefit per Investigator's assessment. Duration of Follow-up: Participants who discontinue study treatment should remain in the study for follow-up. Participants should be followed for collection of survival status, posttreatment therapies (phase 2 and phase 2B), and medical history (phase 2B only) every 12 weeks ( 2 weeks) for the first 2 years then yearly thereafter for an additional 3 years. The maximum duration of follow-up is 5 years (260 weeks).

Guide published for outpatient cancer treatment with bispecific antibodies

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Hematologists with Vanderbilt-Ingram Cancer Center have published strategies for implementing outpatient treatment programs for bispecific antibodies, an immunotherapy that can cause adverse reactions.

The recommendations, published recently in JCO Oncology Practice, detail a comprehensive overview of the potential risks, treatment options for dealing with reactions, prophylactic protocols to prevent them from occurring, and the roles of an interdisciplinary care team within an outpatient program. The team at Vanderbilt-Ingram has expertise in outpatient care models for immunotherapy treatment because Vanderbilt-Ingram was among the first in the nation to establish outpatient protocols for another personalized immunotherapy, CAR-T.

Bispecific antibodies (BsAb) utilize engineered antibodies, molecular spikes, which bind to both cancer cells and immune cells, activating a patient’s T cells to attack hematologic malignancies. With CAR-T (chimeric antigen receptor T-cell therapy), T cells are harvested from a patient, then reengineered to recognize and destroy cancer cells before being infused back into the patient’s body. Both therapies can elicit strong immune responses with complications that pose risks, including cytokine release syndrome, a potentially life-threatening reaction that can damage healthy tissues and organs.

For this reason, the BsAb and CAR-T therapies typically require inpatient monitoring, which can be an economic and logistical burden for both patients and hospitals.

“Bispecific antibodies are a major advance in the field of cancer immunotherapy,” said the article’s corresponding author, Bhagirathbhai Dholaria, MBBS, associate professor of Medicine. “This class of drugs is available off the shelf, which makes them ideal for utilization in the community settings. In this article, we have provided a comprehensive framework to establish an outpatient bispecific antibodies program, especially for community practices, which do not have an already established CAR-T program. Our strategy has the potential to greatly reduce the logistical and financial burden during step-up dosing of bispecific antibodies while maintaining safety of the patients.”

The protocols suggested are for seven BsAb therapies that have been approved by the Food and Drug Administration for non-Hodgkin lymphoma and multiple myeloma. They address potential complications, including cytokine release syndrome, infections, cytopenia, tumor flare reactions, and immune effector cell-mediated neurotoxicity syndrome.

The authors noted that while outpatient programs for CAR-T were established before bispecific antibodies, CAR-T poses higher risks for adverse reactions. Their recommendations prioritize early recognition and intervention for these complications, particularly in the first cycle of treatment with BsAb when most cytokine release syndrome events are likely to occur.

The paper provides an infrastructure and workflow guide for how clinicians can work with patients to implement monitoring and address care needs. They also stress the importance of educating both patients and family/friend caregivers about proper protocols for remote monitoring.

The article’s additional authors are Kian Rahbari, MD, and Raul del Toro Mijares, MD, Kathryn Kennedy, RN, Leslie Mader, RN, Salyka Sengsayadeth, MD, Reena Jayani-Kosarzycki, MD, James Jerkins, MD, Andrew Jallouk, MD, Tae Kon Kim, MD, Shakthi Bhaskar, MD, Vivek Patel, MD, Brittney Baer, RN, Sarah Moseley, RN, David Morgan, MD, Bipin Savani, MD, Adetola Kassim, MD, Muhamed Baljevic, MD, and Olalekan Oluwole, MD.

The post Guide published for outpatient cancer treatment with bispecific antibodies appeared first on VUMC News.

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