Clinical Trials Search at Vanderbilt-Ingram Cancer Center
Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy in Patients with Metastatic Triple Negative Breast Cancer
This phase II trial tests how well evaluating circulating tumor deoxyribonucleic acid (ctDNA) works to guide therapy-change decisions in treating patients with triple-negative breast cancer (TNBC) that has spread from where it first started (primary site) to other places in the body (metastatic). This study wants to learn if small pieces of DNA associated with a tumor (called circulating tumor DNA, or ctDNA) can be detected in investigational blood tests during the course of standard chemotherapy treatment for breast cancer, and whether information from such investigational ctDNA blood testing could possibly be used as an early indication of chemotherapy treatment failure. It is hoped that additional information from investigational blood testing for ctDNA could help doctors to switch more quickly from a standard chemotherapy treatment that typically has significant side effects and which may not be working, to a different standard treatment regimen against TNBC, called sacituzumab govitecan. Sacituzumab govitecan is a monoclonal antibody, called hRS7, linked to a chemotherapy drug, called irinotecan. hRS7 is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers irinotecan to kill them. Studying ctDNA may assist doctors to change therapy earlier if needed, and may improve health outcomes in patients with metastatic TNBC.
Not Available
II
Not Available
NCT05770531
VICCBRE2257
Canakinumab for the Prevention of Progression to Cancer in Patients with Clonal Cytopenias of Unknown Significance, IMPACT Study
This phase II trial tests how well canakinumab works to prevent progression to cancer in patients with clonal cytopenias of unknown significance (CCUS). CCUS is a blood condition defined by a decrease in blood cells. Blood cells are composed of either red blood cells, white blood cells, or platelets. In patients with CCUS, blood counts have been low for a long period of time. Patients with CCUS also have a mutation in one of the genes that are responsible for helping blood cells develop. The combination of genetic mutations and low blood cell counts puts patients with CCUS at a higher risk to develop blood cancers in the future. This transformation from low blood cell counts to cancer may be caused by inflammation in the body. Canakinumab is a monoclonal antibody that may block inflammation in the body by targeting a specific antibody called the anti-human interleukin-1beta (IL-1beta).
Not Available
II
Kishtagari, Ashwin
NCT05641831
VICC-ITHEM23019
Stopping Anti-HER2 Therapy to Improve Outcomes for Exceptional Responder Patients with Metastatic HER2-Positive Breast Cancer, The STOP-HER2 Trial
This phase II trial studies how well stopping anti-HER2 therapy works in improving outcomes of patients with HER2-positive breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and have experienced long-term benefit from first-line treatment (exceptional responders). Patients with metastatic HER2-positive breast cancer are currently treated with systemic drugs indefinitely. These drugs include chemotherapy and/or biological agents targeting the HER2 protein. The first drug combination administered after diagnosis of metastatic spread (i.e., first-line treatment) usually combines chemotherapy with anti-HER2 agents (trastuzumab with or without pertuzumab). Chemotherapy is administered for a limited number of months, and anti-HER2 agents are continued indefinitely as maintenance therapy. Some of these patients experience a long-term benefit from first-line treatment without cancer growth and can be defined as exceptional responders. Nevertheless, all patients with this type of tumor typically continue maintenance treatment with anti-HER2 therapy indefinitely. Exceptional responders usually receive treatment for many years. Information learned from this trial may help researchers understand whether maintenance anti-HER2 treatment can be safely stopped in patients with exceptional response to first-line therapy.
Not Available
II
Abramson, Vandana
NCT05721248
VICC-ETBRE23085
Hormonal Therapy after Pertuzumab and Trastuzumab for the Treatment of Hormone Receptor Positive, HER2 Positive Breast Cancer, the ADEPT study
Breast
Breast
This phase II trial studies the effect of hormonal therapy given after (adjuvant) combination pertuzumab/trastuzumab in treating patients with hormone receptor positive, HER2 positive breast cancer. The drugs trastuzumab and pertuzumab are both monoclonal antibodies, which are disease-fighting proteins made by cloned immune cells. Estrogen can cause the growth of breast cancer cells. Hormonal therapy, such as letrozole, anastrozole, exemestane, and tamoxifen, block the use of estrogen by the tumor cells. Giving hormonal therapy after pertuzumab and trastuzumab may kill any remaining tumor cells in patients with breast cancer.
Breast
II
Abramson, Vandana
NCT04569747
VICCBRE2243
Testing Lutetium Lu 177 Dotatate in Patients with Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors
Lung
Lung
This phase II trial studies the effect of lutetium Lu 177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.
Lung
II
Ramirez, Robert
NCT04665739
SWOGTHOA021901
Testing the Role of DNA Released from Tumor Cells into the Blood in Guiding the Use of Immunotherapy after Surgical Removal of the Bladder for Bladder Cancer Treatment, MODERN Study
This phase II/III trial tests the role of DNA released from tumor cells into the blood in guiding the use of immunotherapy (nivolumab alone or with relatlimab) after surgical removal of the bladder for bladder cancer treatment. DNA is material found inside all of our cells that acts as a blueprint for how cells function. Tumor cells often have abnormal DNA that looks different than DNA in normal cells. A new test called Signatera has been developed that can detect bladder cancer DNA in the blood which might indicate the presence of bladder tumor cells somewhere in the body. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if the Signatera test can better identify which patients need an additional treatment with immunotherapy to help prevent bladder cancer from coming back after surgery.
Not Available
II/III
Tan, Alan
NCT05987241
ALLUROA032103
TPIV100 and Sargramostim for the Treatment of HER2 Positive, Stage I-III Breast Cancer in Patients with Residual Disease after Chemotherapy and Surgery
This phase II trial studies how well TPIV100 and sargramostim work in treating patients with HER2 positive, stage I-III breast cancer that has residual disease after chemotherapy prior to surgery. It also studies why some HER2 positive breast cancer patients respond better to chemotherapy in combination with trastuzumab and pertuzumab. TPIV100 is a type of vaccine made from HER2 peptide that may help the body build an effective immune response to kill tumor cells that express HER2. Sargramostim increases the number of white blood cells in the body following chemotherapy for certain types of cancer and is used to alert the immune system. It is not yet known if TPIV100 and sargramostim will work better in treating patients with HER2 positive, stage I-III breast cancer.
Not Available
II
Not Available
NCT04197687
VICCBRE2241
Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients with an IDH2 Mutation
Multiple Cancer Types
This trial studies the side effects of enasidenib and to see how well it works in treating patients with acute myeloid leukemia that has come back after treatment (relapsed) or has been difficult to treat with chemotherapy (refractory). Patients must also have a specific genetic change, also called a mutation, in a protein called IDH2. Enasidenib may stop the growth of cancer cells by blocking the mutated IDH2 protein, which is needed for cell growth.
Pediatric Leukemia,
Pediatrics
II
Smith, Brianna
NCT04203316
COGADVL18P1
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer
Breast
Breast
This is a multicenter, Phase 1b/2 trial. The phase 1b part of the trial aims to determine the
RP2D of elacestrant when administered in combination with alpelisib, everolimus, palbociclib,
and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the
various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.
RP2D of elacestrant when administered in combination with alpelisib, everolimus, palbociclib,
and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the
various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.
Breast
I/II
Rexer, Brent
NCT05563220
VICC-DTBRE23166P
Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers
This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with the usual treatment with capecitabine in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable) and that it has progressed on previous standard treatment. ZEN003694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that over produce BET protein. Capecitabine is in a class of medications called antimetabolites. It is taken up by cancer cells and breaks down into fluorouracil, a substance that kills cancer cells. Giving ZEN003694 in combination with capecitabine may be safe in treating patients with metastatic or unresectable solid tumors.
Not Available
I
Heumann, Thatcher
NCT05803382
VICC-NTPHI23420
