Clinical Trials Search at Vanderbilt-Ingram Cancer Center
Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study
This study will validate a previously developed pediatric prognostic biomarker algorithm
aimed at improving prediction of risk for the later development of chronic graft-versus-host
disease (cGvHD) in children and young adults undergoing allogeneic hematopoietic stem cell
transplant.
By developing an early risk stratification of patients into low-, intermediate-, and
high-risk for future cGvHD development (based upon their biomarker profile, before the onset
of cGvHD), pre-emptive therapies aimed at preventing the onset of cGvHD can be developed
based upon an individual's biological risk profile.
This study will also continue research into diagnostic biomarkers of cGvHD, and begin work
into biomarker models that predict clinical response to cGvHD therapies.
aimed at improving prediction of risk for the later development of chronic graft-versus-host
disease (cGvHD) in children and young adults undergoing allogeneic hematopoietic stem cell
transplant.
By developing an early risk stratification of patients into low-, intermediate-, and
high-risk for future cGvHD development (based upon their biomarker profile, before the onset
of cGvHD), pre-emptive therapies aimed at preventing the onset of cGvHD can be developed
based upon an individual's biological risk profile.
This study will also continue research into diagnostic biomarkers of cGvHD, and begin work
into biomarker models that predict clinical response to cGvHD therapies.
Not Available
N/A
Kitko, Carrie
NCT04372524
VICCPED2183
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Miscellaneous
Miscellaneous
This is an observational case-control study to train and validate a genome-wide methylome
enrichment platform to detect multiple cancer types and to differentiate amongst cancer
types. The cancers included in this study are brain, breast, bladder, cervical, colorectal,
endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma,
multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid. These cancers
were selected based on their prevalence and mortality to maximize impact on clinical care.
Additionally, the ability of the whole-genome methylome enrichment platform to detect minimal
residual disease after completion of cancer treatment and to detect relapse prior to clinical
presentation will be evaluated in four cancer types (breast, colorectal, lung, prostate).
These cancers were selected based on the existing clinical landscape and treatment
availability.
enrichment platform to detect multiple cancer types and to differentiate amongst cancer
types. The cancers included in this study are brain, breast, bladder, cervical, colorectal,
endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma,
multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid. These cancers
were selected based on their prevalence and mortality to maximize impact on clinical care.
Additionally, the ability of the whole-genome methylome enrichment platform to detect minimal
residual disease after completion of cancer treatment and to detect relapse prior to clinical
presentation will be evaluated in four cancer types (breast, colorectal, lung, prostate).
These cancers were selected based on the existing clinical landscape and treatment
availability.
Miscellaneous
N/A
Rini, Brian
NCT05366881
VICCMD21111
Disposable Perfusion Phantom for Accurate DCE-MRI Measurement of Pancreatic Cancer Therapy Response
Pancreatic
Pancreatic
This trial tests the use of a disposable perfusion phantom (P4) to decrease errors in calculating the blood flow of a tissue with DCE-MRI. DCE-MRI is used calculate blood flow of various tissues including tumors. Blood flow often serves as a critical indicator showing a disease status. For example, a pancreatic tumor has typically low blood flow, so it can be used as an indicator to identify the presence of a pancreatic tumor. In addition, an effective therapy may result in the increase of blood flow in a pancreatic tumor during the early period of treatment. Therefore, DCE-MRI may be used to determine whether the undergoing therapy is effective or not by measuring the change of blood flow in the pancreatic tumor and may help doctors decide whether to continue the therapy or try a different one. Unfortunately, the measurement of blood flow using DCE-MRI is not accurate. The use of an artificial tissue, named "phantom" or P4, together with a patient may help to reduce errors in DCE-MRI because errors will affect the images of both the patient and the phantom. Because it is known how the blood flow of the phantom appears when no errors are present, the phantom may be used to detect what kinds of errors are present in the image, how many errors are present in the image, and how to remove errors from the image.
Pancreatic
N/A
Xu, Junzhong
NCT04588025
VICCGI2099
Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients with Head and Neck Cancer
Phase I
Phase I
This phase I trial evaluates the safety and effectiveness of using two imaging techniques, indium In 111 panitumumab (111In-panitumumab) with single photon emission computed tomography (SPECT)/computed tomography (CT) and panitumumab-IRDye800 fluorescence imaging during surgery (intraoperative), to detect disease in patients with head and neck cancer. 111In-panitumumab is an imaging agent made of a monoclonal antibody that has been labeled with a radioactive molecule called indium In 111. The agent targets and binds to receptors on tumor cells. This allows the cells to be visualized and assessed with SPECT/CT imaging techniques. SPECT is special type of CT scan in which a small amount of a radioactive drug is injected into a vein and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the cells. CT is an imaging technique for examining structures within the body by scanning them with x-rays and using a computer to construct a series of cross-sectional scans along a single axis. Panitumumab-IRDye800 is an imaging agent composed of panitumumab, a monoclonal antibody, linked to a fluorescent dye called IRDye800. Upon administration, panitumumab-IRDye800 targets and binds to receptors on tumor cells. This allows the tumor cells to be detected using fluorescence imaging during surgery. Adding 111In-panitumumab SPECT/CT imaging to intraoperative panitumumab-IRDye800 fluorescence imaging may be more effective at detecting disease in patients with head and neck cancer.
Phase I
I
Rosenthal, Eben
NCT05945875
VICC-EDHAN23204P
111In-Panitumumab for Nodal Staging in Patients with Head and Neck Cancer
Multiple Cancer Types
This phase I trial tests the safety and effectiveness of indium In 111 panitumumab (111In-panitumumab) for identifying the first lymph nodes to which cancer has spread from the primary tumor (sentinel lymph nodes) in patients with head and neck squamous cell carcinoma (HNSCC) undergoing surgery. The most important factor for survival for many cancer types is the presence of cancer that has spread to the lymph nodes (metastasis). Lymph node metastases in patients with head and neck cancer reduce the 5-year survival by half. Sometimes, the disease is too small to be found on clinical and imaging exams before surgery. 111In-panitumumab is in a class of medications called radioimmunoconjugates. It is composed of a radioactive substance (indium In 111) linked to a monoclonal antibody (panitumumab). Panitumumab binds to EGFR receptors, a receptor that is over-expressed on the surface of many tumor cells and plays a role in tumor cell growth. Once 111In-panitumumab binds to tumor cells, it is able to be seen using an imaging technique called single photon emission computed tomography/computed tomography (SPECT/CT). SPECT/CT can be used to make detailed pictures of the inside of the body and to visualize areas where the radioactive drug has been taken up by the cells. Using 111In-panitumumab with SPECT/CT imaging may improve identification of sentinel lymph nodes in patients with head and neck squamous cell cancer undergoing surgery.
Head/Neck,
Phase I
I
Rosenthal, Eben
NCT05901545
VICC-EDHAN23201P
A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With Select Solid Tumors
Multiple Cancer Types
The goal of this clinical trial is to evaluate the safety of TOS-358 in adults with select
solid tumors who meet study enrollment criteria. The main questions it aims to answer are:
1. what is the maximum tolerated dose and recommended dose for phase 2?
2. how safe and tolerable is TOS-358 at different dose levels when taken orally once or
twice per day?
solid tumors who meet study enrollment criteria. The main questions it aims to answer are:
1. what is the maximum tolerated dose and recommended dose for phase 2?
2. how safe and tolerable is TOS-358 at different dose levels when taken orally once or
twice per day?
Breast,
Cervical,
Gastrointestinal,
Gynecologic,
Head/Neck,
Lung,
Phase I,
Urologic
I
Berlin, Jordan
NCT05683418
VICC-DTPHI23103
A Study of E7386 in Combination With Other Anticancer Drug in Participants With Solid Tumor
Multiple Cancer Types
The primary objective of this study is to assess the safety and tolerability and to determine
the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s).
the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s).
Gynecologic,
Liver,
Phase I
I
Heumann, Thatcher
NCT04008797
VICC-DTPHI23106
A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)
Melanoma
Melanoma
The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab
with respect to recurrence-free survival (RFS). The primary hypothesis is that
pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by
the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma.
with respect to recurrence-free survival (RFS). The primary hypothesis is that
pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by
the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma.
Melanoma
III
Johnson, Douglas
NCT05665595
VICC-DTMEL23033
Dose Optimization and Expansion Study of DFV890 in Adult Patients With Myeloid Diseases
Hematologic
Hematologic
Study CDFV890G12101 is an open-label, phase 1b, multicenter study with a randomized two-dose
optimization part, and a dose expansion part consisting of two groups evaluating DFV890 in
patients with myeloid diseases. The purpose of this study is to assess the safety,
tolerability, pharmacokinetics, pharmacodynamics, efficacy and recommended dose for single
agent DFV890 in patients with lower risk (LR: very low, low or intermediate risk)
myelodysplastic syndromes (LR MDS) and lower risk chronic myelomonocytic leukemia (LR CMML).
optimization part, and a dose expansion part consisting of two groups evaluating DFV890 in
patients with myeloid diseases. The purpose of this study is to assess the safety,
tolerability, pharmacokinetics, pharmacodynamics, efficacy and recommended dose for single
agent DFV890 in patients with lower risk (LR: very low, low or intermediate risk)
myelodysplastic syndromes (LR MDS) and lower risk chronic myelomonocytic leukemia (LR CMML).
Hematologic
I
Kishtagari, Ashwin
NCT05552469
VICC-DTHEM23007P
Acalabrutinib for the Treatment of Chronic Graft Versus Host Disease
Miscellaneous
Miscellaneous
This phase II trial studies how well acalabrutinib works in treating patients with chronic graft versus host disease. Acalabrutinib may be an effective treatment for graft-versus-host disease caused by a stem cell transplant.
Miscellaneous
II
Kitko, Carrie
NCT04198922
VICCCTT2122
