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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/ |
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.
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.
Colon,
Rectal
III
Eng, Cathy
NCT04607421
VICCGI2085
Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)
Multiple Cancer Types
The Phase 1 portion of this study is a single-arm, open-label, multicenter, non-randomized
interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and efficacy
of ASTX727 when given in combination with venetoclax for the treatment of newly diagnosed
acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have
comorbidities that preclude use of intensive induction chemotherapy. The primary purpose of
the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination
therapy by evaluating area under the curve (AUC) and maximum plasma concentration (Cmax)
exposure. The Phase 2 portion of the study is to assess the efficacy of ASTX727 and
venetoclax when given in combination and to evaluate potential PK interactions. Phase 2 will
follow the same overall study design as Phase 1 and has two parts, Part A and Part B.
interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and efficacy
of ASTX727 when given in combination with venetoclax for the treatment of newly diagnosed
acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have
comorbidities that preclude use of intensive induction chemotherapy. The primary purpose of
the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination
therapy by evaluating area under the curve (AUC) and maximum plasma concentration (Cmax)
exposure. The Phase 2 portion of the study is to assess the efficacy of ASTX727 and
venetoclax when given in combination and to evaluate potential PK interactions. Phase 2 will
follow the same overall study design as Phase 1 and has two parts, Part A and Part B.
Leukemia,
Phase I
I/II
Savona, Michael
NCT04657081
VICCHEMP20102
Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)
Multiple Cancer Types
A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone
(fludarabine/cytarabine/gemtuzumab ozogamicin [GO]) improves survival of
children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are
unable to receive additional anthracyclines, or in 2nd relapse.
(fludarabine/cytarabine/gemtuzumab ozogamicin [GO]) improves survival of
children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are
unable to receive additional anthracyclines, or in 2nd relapse.
Pediatric Leukemia,
Pediatrics
III
Smith, Christine
NCT05183035
VICCPED2237
Nilotinib, Trametinib, and Dabrafenib for the Treatment of BRAF V600 Mutant Metastatic or Unresectable Melanoma
Multiple Cancer Types
This phase I trial is to find out the best dose, possible benefits and/or side effects of nilotinib given together with trametinib and dabrafenib in treating patients with BRAF V600 mutant melanoma that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Nilotinib, trametinib, and dabrafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nilotinib together with trametinib and dabrafenib may lower the chance of cancer growing or spreading.
Melanoma,
Phase I
I
Johnson, Douglas
NCT04903119
VICCMELP2274
Evaluation of SNDX-5613 in Participants With Colorectal Cancer and Other Solid Tumors
Phase I
Phase I
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor
activity of SNDX-5613 in participants with colorectal cancer (CRC) or other solid tumors who
have failed at least 1 prior line of therapy.
activity of SNDX-5613 in participants with colorectal cancer (CRC) or other solid tumors who
have failed at least 1 prior line of therapy.
Phase I
I/II
Ciombor, Kristen
NCT05731947
VICCPHI22111
Evexomostat Plus Alpelisib and Fulvestrant in Women With the PIK3CA Mutation With HR+/Her2- Breast Cancer
The PIK3CA gene is frequently mutated in breast cancer, leading to disease aggressiveness and
patient mortality. Alpelisib, a small molecule that inhibits the activity of the PIK3CA gene
product PI3K, has demonstrated clinical benefit in cancer patients with this gene mutation.
However, hyperglycemia, an on-target toxicity associated with alpelisib that leads to
hyperinsulinemia, limits the drug's clinical efficacy and induces high grade hyperglycemia in
patients with baseline metabolic dysfunction, insulin resistance and/or elevated HbA1c.
Restoring insulin sensitivity and reduction in circulating concentrations of insulin have
been reported to improve the activity of alpelisib.
Evexomostat (SDX-7320) is a polymer-conjugate of a novel small molecule methionine
aminopeptidase 2 (MetAP2) inhibitor that has demonstrated the ability to reduce
alpelisib-induced hyperglycemia in multiple animal experiments and has demonstrated
synergistic anti-tumor activity independent of changes in glucose or insulin. Evexomostat was
well tolerated in a Phase 1 safety study in late-stage cancer patients and showed
improvements in insulin resistance for patients that presented with baseline elevated
insulin. Overall, the most common treatment-emergent adverse events with evexomostat (TEAEs)
were fatigue (44%), decreased appetite (38%), constipation and nausea (each 28%), and
diarrhea (22%). All other TEAEs occurred at an incidence <20%.
The purpose of this study is to characterize the safety of the triplet drug combination
(alpelisib, fulvestrant plus evexomostat), to test whether evexomostat, when given in
combination with alpelisib and fulvestrant will reduce the number and severity of
hyperglycemic events and/or reduce the number of anti-diabetic medications needed to control
the hyperglycemia for patients deemed at risk for alpelisib-induced hyperglycemia (baseline
elevated HbA1c or well-controlled type 2 diabetes), and to assess preliminary anti-tumor
efficacy and changes in key biomarkers and quality of life in this patient population.
patient mortality. Alpelisib, a small molecule that inhibits the activity of the PIK3CA gene
product PI3K, has demonstrated clinical benefit in cancer patients with this gene mutation.
However, hyperglycemia, an on-target toxicity associated with alpelisib that leads to
hyperinsulinemia, limits the drug's clinical efficacy and induces high grade hyperglycemia in
patients with baseline metabolic dysfunction, insulin resistance and/or elevated HbA1c.
Restoring insulin sensitivity and reduction in circulating concentrations of insulin have
been reported to improve the activity of alpelisib.
Evexomostat (SDX-7320) is a polymer-conjugate of a novel small molecule methionine
aminopeptidase 2 (MetAP2) inhibitor that has demonstrated the ability to reduce
alpelisib-induced hyperglycemia in multiple animal experiments and has demonstrated
synergistic anti-tumor activity independent of changes in glucose or insulin. Evexomostat was
well tolerated in a Phase 1 safety study in late-stage cancer patients and showed
improvements in insulin resistance for patients that presented with baseline elevated
insulin. Overall, the most common treatment-emergent adverse events with evexomostat (TEAEs)
were fatigue (44%), decreased appetite (38%), constipation and nausea (each 28%), and
diarrhea (22%). All other TEAEs occurred at an incidence <20%.
The purpose of this study is to characterize the safety of the triplet drug combination
(alpelisib, fulvestrant plus evexomostat), to test whether evexomostat, when given in
combination with alpelisib and fulvestrant will reduce the number and severity of
hyperglycemic events and/or reduce the number of anti-diabetic medications needed to control
the hyperglycemia for patients deemed at risk for alpelisib-induced hyperglycemia (baseline
elevated HbA1c or well-controlled type 2 diabetes), and to assess preliminary anti-tumor
efficacy and changes in key biomarkers and quality of life in this patient population.
Not Available
I/II
Rexer, Brent
NCT05455619
VICCBREP2271
Capecitabine Compared to Endocrine Therapy for the Treatment of Non-luminal A Hormone Receptor-Positive Metastatic Breast Cancer
Breast
Breast
This phase II trial compares the effect of capecitabine to endocrine therapy in patients with non-Luminal A hormone receptor-positive breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). In this study, patients submit a sample of tumor for testing to determine if their breast cancer is considered non-Luminal A. Only patients with non-Luminal A receive study treatment. In the future, doctors hope that this test can assist in picking the best treatment for patients with this type of cancer. Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Endocrine therapy is treatment that adds, blocks, or removes hormones. To slow or stop the growth of certain cancers (such as prostate and breast cancer), synthetic hormones or other drugs may be given to block the body's natural hormones. Giving capecitabine as compared to endocrine therapy may kill more tumor cells in patients with metastatic breast cancer.
Breast
II
Reid, Sonya
NCT05693766
VICCBRE2256
Decitabine and Cedazuridine in Combination with Venetoclax for the Treatment of Patients who have Relapsed Acute Myeloid Leukemia after Donor Stem Cell Transplant
Leukemia
Leukemia
This phase II trial tests how well decitabine and cedazuridine (DEC-C) works in combination with venetoclax in treating acute myeloid leukemia (AML) in patients whose AML has come back after a period of improvement (relapse) after a donor stem cell transplant. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving DEC-C in combination with venetoclax may kill more cancer cells in patients with relapsed AML.
Leukemia
II
Mohan, Sanjay
NCT05799079
VICCHEM2163
Total Body Irradiation and Hypofractionated Radiation Therapy with Atezolizumab and Chemotherapy for the Treatment of Extensive-Stage Small Cell Lung Cancer, TESSERACT Trial
Multiple Cancer Types
This phase I/II trial studies the side effects, safety, and effectiveness of low dose radiation to the entire body (total body irradiation [TBI]) and higher dose radiation to known areas of cancer (hypofractionated radiation therapy [H-RT]) combined with atezolizumab and chemotherapy (carboplatin & etoposide) in treating patients with small cell lung cancer that has spread to disease sites outside of the lung (extensive stage). Extensive stage disease has historically been treated with chemotherapy alone with consideration of chest (thoracic) radiation therapy for those with response to chemotherapy, as well as consideration of preventative radiation therapy to the head (prophylactic cranial irradiation). Emerging evidence supports the synergistic interactions between immunotherapy and radiation therapy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Combining TBI and H-RT with atezolizumab and chemotherapy may improve response to treatment.
Lung,
Small Cell
I/II
Osmundson, Evan
NCT06110572
VICCTHOP2206
Selinexor and Venetoclax in Combination with Chemotherapy for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Leukemia of Ambiguous Lineage
Multiple Cancer Types
This phase I trial evaluates the side effects and best dose of selinexor and venetoclax in combination with chemotherapy in treating patients with acute myeloid leukemia or acute leukemia of ambiguous linage that has come back (relapsed) or does not respond to treatment. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Selinexor may stop the growth of cancer cells by blocking CRM1, which help the body's immune system to find and kill cancer cells. Chemotherapy drugs, such as fludarabine and cytarabine, 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. Colony-stimulating factors, such as granulocyte colony-stimulating factor, may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Giving venetoclax and selinexor with chemotherapy may help control the disease in patients with acute myeloid leukemia or acute leukemia of ambiguous lineage.
Leukemia,
Pediatric Leukemia,
Pediatrics,
Phase I
I
Smith, Brianna
NCT04898894
VICCPEDP2235
