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Consuelo Wilkins, MD, MSCI, Senior Vice President for Health Equity and Inclusive Excellence for Vanderbilt University Medical Center (VUMC) and Senior Associate Dean for Health Equity and Inclusive Excellence for Vanderbilt University School of Medicine, always knew she wanted to be a physician. "Health equity was built into everything I did, even if I didn’t know it or recognize it at the time," Wilkins said. "I have always learned and believed that people are the same — everyone deserves to be healthy, and everyone should have the best opportunities to take care of themselves and their families." Click below to learn more about health equity initiatives.

https://momentum.vicc.org/2021/09/everyone-deserves-to-be-healthy/

Vanderbilt was the lead site for an NIH-funded, phase 2, multicenter influenza vaccine study in pediatric allogeneic hematopoietic stem cell transplant (HCT) recipients that may lead to a change in the current flu vaccine recommendations in this vulnerable population. Natasha Halasa, MD, MPH and colleagues recently published in the New England Journal of Medicine, that two doses of high-dose trivalent flu vaccine resulted in higher amounts of influenza-specific antibodies than two doses of standard dose quadrivalent vaccine.

https://news.vumc.org/2023/03/02/high-dose-flu-vaccine-beneficial-for-pediatric-stem-cell-transplant-patients/

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‘Multi-omics’ reveals treatment option for breast cancer subtype

In a multidisciplinary collaboration, researchers at Vanderbilt University Medical Center and the University of Miami Miller School of Medicine have identified a subtype of triple-negative breast cancer (TNBC) that appears to be able to escape detection by the immune system and evade immunotherapy.

https://news.vumc.org/2021/11/18/multi-omics-reveals-treatment-option-for-breast-cancer-subtype/

Fri, 11/18/2022 - 12:00

Breast_SPORE

Study identifies biomarker for breast cancer response to immunotherapy

A biomarker that has proven to be a predictor for response to immunotherapies in melanoma patients also has clinical relevance for breast cancer patients, according to a new study published in Clinical Cancer Research, a journal of the American Association for Cancer Research.

https://news.vumc.org/2021/08/12/study-identifies-biomarker-for-breast-cancer-response-to-immunotherapy/

Fri, 08/12/2022 - 12:00

Breast_SPORE

Testing the use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy with Docetaxel plus Trastuzumab) for Recurrent, Metastatic, or Unresectable HER2-Positive Salivary Gland Cancer

Head/Neck

This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-positive salivary gland cancer that has come back (recurrent), that has spread from where it first started (primary site) to other places in the body, or cannot be removed by surgery (unresectable). Trastuzumab is a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by body's immune system. Trastuzumab emtansine contains trastuzumab, linked to a chemotherapy drug called emtansine. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers emtansine to kill them. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Trastuzumab emtansine may work better compared to usual treatment of chemotherapy with docetaxel and trastuzumab in treating patients with recurrent, metastatic or unresectable salivary gland cancer.

Disease Sites: Head/Neck

Phase: II

Investigator: Choe, Jennifer

NCTID: NCT05408845

Protocol No: NRGHN010

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Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)

Lymphoma

This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib
monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in
combination with one of two different high dose methotrexate based regimens (methotrexate/
temozolomide/rituximab or rituximab/methotrexate/procarbazine/ vincristine) as first line
therapy in patients with newly diagnosed, treatment nave PCNSL (Part B)

Disease Sites: Lymphoma

Phase: II

Investigator: Merrell, Ryan

NCTID: NCT04947319

Protocol No: VICCNEU2250

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Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell Transplant

Hematologic

A study to evaluate ALVR106; an allogeneic, off-the-shelf multi-virus specific T cell therapy
that targets four community acquired respiratory viruses: respiratory syncytial virus (RSV),
influenza, human metapneumovirus (hMPV), and/or parainfluenza virus (PIV) following
hematopoietic cell transplant (HCT)

Disease Sites: Hematologic

Phase: I/II

Investigator: Dholaria, Bhagirathbhai

NCTID: NCT04933968

Protocol No: VICCCTT2098

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Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients with High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy

Multiple Cancer Types

This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial will also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy.

The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.

Disease Sites: Pediatric Leukemia, Pediatrics

Phase: III

Investigator: Zarnegar-Lumley, Sara

NCTID: NCT03959085

Protocol No: COGAALL1732

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A Study to Compare Treatment with the Drug Selumetinib Alone versus Selumetinib and Vinblastine in Patients with Recurrent or Progressive Low-Grade Glioma

This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment (recurrent) or does not respond to therapy (progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells. Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma.

Disease Sites: Not Available

Phase: III

Investigator: Esbenshade, Adam

NCTID: NCT04576117

Protocol No: COGACNS1931

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Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma

Multiple Cancer Types

This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.

Disease Sites: Pediatrics, Sarcoma

Phase: III

Investigator: Borinstein, Scott

NCTID: NCT05235165

Protocol No: COGAOST2031

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A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer

Multiple Cancer Types

The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab)
taken alone or together with standard chemotherapy for the potential treatment of colorectal
cancer that:

- has spread to other parts of the body (metastatic);

- has a certain type of abnormal gene called "BRAF"; and

- has not received prior treatment.

Participants in this study will receive one of the following study treatments:

- Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home
every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection
into the vein) at the study clinic.

- Encorafenib plus cetuximab with chemotherapy: These participants will receive
encorafenib and cetuximab in the way described in the bullet above. Additionally, they
will receive standard chemotherapy by IV infusion and oral treatment at home.

- Chemotherapy alone: These participants will receive chemotherapy, the standard treatment
for this condition, by IV infusion at the study clinics and oral treatment at home.

The study team will monitor how each participant responds to the study treatment for up to
about 3 years.

Disease Sites: Colon, Rectal

Phase: III

Investigator: Eng, Cathy

NCTID: NCT04607421

Protocol No: VICCGI2085

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Brightline-1: A Study to Compare BI 907828 With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma

Sarcoma

This study is open to people with a type of cancer called dedifferentiated liposarcoma.
People with advanced liposarcoma aged 18 or older who are not receiving any other cancer
treatment can participate.

The purpose of this study is to compare a medicine called BI 907828 with doxorubicin in
people with liposarcoma. BI 907828 is a so-called MDM2 inhibitor that is being developed to
treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma.

During the study, participants get either BI 907828 or doxorubicin. Every 3 weeks,
participants take BI 907828 as tablets or doxorubicin as an infusion into a vein.
Participants can switch to BI 907828 treatment if they did not benefit from doxorubicin
treatment.

Participants can continue treatment in the study as long as they benefit from it and can
tolerate it.

Doctors regularly check the size of the tumour and check whether it has spread to other parts
of the body. The doctors also regularly check participants' health and take note of any
unwanted effects.

Disease Sites: Sarcoma

Phase: II/III

Investigator: Keedy, Vicki

NCTID: NCT05218499

Protocol No: VICCSAR2217

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