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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



A Study of ASTX030 (Cedazuridine in Combination With Azacitidine) in MDS, CMML, or AML

Multiple Cancer Types

Study ASTX030-01 is designed to move efficiently from Phase 1 to Phase 3. Phase 1 consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B) of ASTX030. Phase 2 is a randomized open-label crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 is a randomized open-label crossover study comparing the final oral ASTX030 tablet to SC azacitidine. The duration of the study is expected to be approximately 36 months.
Leukemia, Myelodysplastic Syndrome, Phase I
I/II/III
Savona, Michael
NCT04256317
VICCHEMP19146

Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ mTNBC

Breast

This is a phase Ib / II Study of Leronlimab (PRO 140) combined with Carboplatin in Patients with CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC). Study population will consist of patients with CCR5-positive, locally advanced or metastatic triple-negative breast cancer (mTNBC) who are naïve to chemotherapy in metastatic setting but have been exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings (first-line).
Breast
I/II
Abramson, Vandana
NCT03838367
VICCBREP1983

Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC

Multiple Cancer Types

Evaluate the safety and efficacy of the combination of eftilagimod alpha with pembrolizumab in non-small cell lung carcinoma and head and neck carcinoma patients.
Lung, Non Small Cell
II
Horn, Leora
NCT03625323
VICCTHO1930

Multimodality Therapy before and after Surgery in Patients with Squamous Cell Carcinoma of the Head and Neck

Head/Neck

This phase II clinical trial studies how well multimodality therapy works before and after surgery in patients with squamous cell carcinoma of the head and neck. Immunotherapy with monoclonal antibodies, such as durvalumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin, nab-paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving carboplatin, nab-paclitaxel, and durvalumab before surgery and using durvalumab with or without radiation therapy and cisplatin after surgery may kill more tumor cells in patients with head and neck cancer.
Head/Neck
II
Gibson, Mike
NCT03174275
VICCHN1890

Galunisertib and Paclitaxel in Treating Patients with Metastatic Androgen Receptor Negative or Triple Negative Breast Cancer

Breast

This phase I trial studies the side effects and best dose of galunisertib when given together with paclitaxel in treating patients with androgen receptor negative or triple negative breast cancer that has spread to other places in the body. Some tumors need growth factors, which are made by the body's white blood cells, to keep growing. Galunisertib may interfere with growth factors and help cause tumor cells to die. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving glunisertib together with paclitaxel may kill more tumor cells.
Breast
I
Abramson, Vandana
NCT02672475
VICCBRE1557

Covered Metal Stents versus Uncovered Metal Stents for the Treatment of Jaundice due to Pancreatic Cancer, Cholangiocarcinoma, or Other Metastatic Malignancies

Multiple Cancer Types

This trial studies how well covered metal stents versus uncovered metal stents work in treating patients with jaundice due to pancreatic cancer, cholangiocarcinoma (bile duct), or other malignancies that have spread to other places in the body (metastatic). Jaundice can make the skin and urine appear very yellow and cause itching throughout the body. Pancreatic cancer, cholangiocarcinoma, or other metastatic malignancies can cause jaundice by blocking the bile duct. The bile duct is a tube-like structure that drains the liver. To maintain an opening in the bile duct, a stent is placed. Uncovered self-expanding metal biliary stents have a bare metal scaffold that the tissue tends to grow into and thus blocks the stent from draining, while covered self-expanding metal biliary stents have a polyurethane coating that may prevent the tissue from growing into the stent and thus blocking the stent. It is not yet known whether covered or uncovered metal stents may work better in treating patients with jaundice.
Gastrointestinal, Pancreatic
N/A
Yachimski, Patrick
NCT01905384
VICCGI1984

Ketogenic Diet with Letrozole in Treating Patients with Estrogen Receptor Positive Breast Cancer

Breast

This early phase I trial studies how well ketogenic diet with letrozole works in treating patients with estrogen receptor positive breast cancer. Estrogen receptor positive breast cancer has special proteins on it, called estrogen receptors, that allow it to grow when exposed to estrogen. A ketogenic diet (low calorie, low carbohydrate) may help normalize abnormally high insulin levels that in turn may slow the growth of cancer cells. Letrozole may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.The purpose of this study is to learn if the combination of a 2 week ketogenic diet in combination with letrozole can help slow the growth of tumors.
Breast
Early I
Rexer, Brent
NCT03962647
VICCBRE18108

Capecitabine and Radiation Therapy after Surgery in Treating Patients with Non-Metastatic Invasive Breast cancer

Multiple Cancer Types

This phase I trial studies how well capecitabine and radiation therapy after surgery work in treating patients with invasive breast cancer that has not spread to other places in the body. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving capecitabine and radiation therapy together may kill more tumor cells in patients with invasive breast cancer compared to capecitabine or radiation therapy alone.
Breast, Phase I
I
Chak, Bapsi
NCT03958721
VICCBREP1898

Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease

Hematologic

This study evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the treatment of ocular Graft Verses Host Disease (oGVHD). Two thirds of participants will receive Brimonidine and one third will receive ophthalmic buffered saline (placebo).
Hematologic
III
Tran, Uyen
NCT03591874
VICCBMT19132

Integrated Telehealth or In-Person Palliative Care in Improving Quality of Life in Patients with Advanced Non-small Cell Lung Cancer

Multiple Cancer Types

This randomized clinical trial studies how well integrated telehealth or in-person palliative care works in improving quality of life in patients with non-small lung cancer that has spread to other places in the body. Early involvement in palliative care may lesson many of the distressing physical and emotional symptoms and help patients and their families cope with serious illness as well as improve patients’ and their loved ones’ experience with cancer. Integrated telehealth palliative care involves patients meeting with palliative care clinicians using secure video-conferencing technology. It is not yet known whether giving integrated telehealth or in-person palliative care works better for patients and their families in improving quality of life.
Lung, Non Small Cell
N/A
Martin, Sara
NCT03375489
VICCTHO1839

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