Clinical Trials Search at Vanderbilt-Ingram Cancer Center
Vincristine Pharmacokinetics in Infants
Pediatrics
Pediatrics
This pilot trial compares drug exposure levels using a new method for dosing vincristine in infants and young children compared to the standard dosing method based on body surface area (BSA) in older children. Vincristine is an anticancer drug used to a variety of childhood cancers. The doses anticancer drugs in children must be adjusted based on the size of the child because children vary significantly in size (height, weight, and BSA) and ability to metabolize drugs from infancy to adolescence. The dose of most anticancer drugs is adjusted to BSA, which is calculated from a patients weight and height. However, infants and young children have more severe side effects if the BSA is used to calculate their dose, so new dosing models have to be made to safely give anticancer drugs to the youngest patients. This new method uses a BSA-banded approach to determine the dose. Collecting blood samples before and after a dose of the drug will help researchers determine whether this new vincristine dosing method results in equivalent drug levels in the blood over time in infants and young children compared to older children.
Pediatrics
N/A
Borinstein, Scott
NCT05359237
COGPEPN22P1
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
An Imaging Agent (89Zr Panitumumab) with PET/CT for Diagnosing Primary Lesions and/or Metastases in Patients with Head and Neck Squamous Cell Carcinoma
Head/Neck
Head/Neck
This phase I trial evaluates the usefulness of an imaging agent (zirconium Zr 89 panitumumab [89Zr panitumumab]) with positron emission tomography (PET)/computed tomography (CT) for diagnosing primary tumors and/or the spread of disease from where it first started (primary site) to other places in the body (metastasis) in patients with head and neck squamous cell carcinoma. 89Zr panitumumab is an investigational imaging agent that contains a small amount of radiation, which makes it visible on PET scans. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 89Zr panitumumab, to allow imaging of the function of different cells and organs in the body. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs and potential disease tissue where it occurs in patients body. The combined PET/CT scanner is a special type of scanner that allows imaging of both structure (CT) and function (PET) following the injection of 89Zr panitumumab. This 89Zr panitumumab PET/CT may be useful in diagnosis of primary tumors and/or metastasis in patients with head and neck squamous cell carcinoma.
Head/Neck
I
Topf, Michael
NCT05747625
VICCHN2279
A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma
Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is
typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can
cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are
available, but MM can come back (relapsed) or may not get better (refractory) with treatment.
This is a study to determine adverse events and change in disease symptoms of ABBV-383 in
adult participants with relapsed/refractory (R/R) MM.
ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma
(MM). This study is broken into 2 Arms; Arm A (Parts 1 and 2) and Arm B. Arm A includes 2
parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different
level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the
step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of
ABBV-383. In Arm B a flat dose of ABBV-383 will be tested. Around 120 adult participants with
relapsed/refractory multiple myeloma will be enrolled at approximately 30 sites across the
world.
Participants will receive ABBV-383 as an infusion into the vein in 28 day cycles for
approximately 3 years.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital or
clinic. The effect of the treatment will be checked by medical assessments, blood tests,
checking for side effects and questionnaires.
typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can
cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are
available, but MM can come back (relapsed) or may not get better (refractory) with treatment.
This is a study to determine adverse events and change in disease symptoms of ABBV-383 in
adult participants with relapsed/refractory (R/R) MM.
ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma
(MM). This study is broken into 2 Arms; Arm A (Parts 1 and 2) and Arm B. Arm A includes 2
parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different
level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the
step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of
ABBV-383. In Arm B a flat dose of ABBV-383 will be tested. Around 120 adult participants with
relapsed/refractory multiple myeloma will be enrolled at approximately 30 sites across the
world.
Participants will receive ABBV-383 as an infusion into the vein in 28 day cycles for
approximately 3 years.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital or
clinic. The effect of the treatment will be checked by medical assessments, blood tests,
checking for side effects and questionnaires.
Not Available
I
Not Available
NCT05650632
VICC-DTPCL23010P
Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and
preliminary antitumor activity of TYRA-300 in cancers with FGFR3 activating gene alterations,
including locally advanced/metastatic urothelial carcinoma of the bladder and urinary tract
and other advanced solid tumors.
preliminary antitumor activity of TYRA-300 in cancers with FGFR3 activating gene alterations,
including locally advanced/metastatic urothelial carcinoma of the bladder and urinary tract
and other advanced solid tumors.
Not Available
I/II
Berlin, Jordan
NCT05544552
VICCPHI2261
Phase 1/2 Study of MRTX1719 in Solid Tumors With MTAP Deletion
This is a Phase 1/2, open-label, multicenter, study of the safety, tolerability, PK, PD, and
anti-tumor activity of MRTX1719 patients with advanced, unresectable or metastatic solid
tumor malignancy with homozygous deletion of the MTAP gene.
anti-tumor activity of MRTX1719 patients with advanced, unresectable or metastatic solid
tumor malignancy with homozygous deletion of the MTAP gene.
Not Available
I/II
Davis, Elizabeth
NCT05245500
VICC-DTPHI23101P
Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma (ALPHA2)
The purpose of the ALPHA-2 study is to assess the safety, efficacy, and cell kinetics of
ALLO-501A in adults with relapsed or refractory large B-cell lymphoma after a lymphodepletion
regimen comprising fludarabine, cyclophosphamide, and ALLO-647
ALLO-501A in adults with relapsed or refractory large B-cell lymphoma after a lymphodepletion
regimen comprising fludarabine, cyclophosphamide, and ALLO-647
Not Available
II
Jallouk, Andrew
NCT04416984
VICC-DTCTT24008
Testing the Combination of New Anti-cancer Drug Peposertib with Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies
This phase I/II trial studies the best dose and side effects of peposertib and to see how well it works with avelumab and hypofractionated radiation therapy in treating patients with solid tumors and hepatobiliary malignancies that have spread to other places in the body (advanced/metastatic). Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the bodys immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving peposertib in combination with avelumab and hypofractionated radiation therapy may work better than other standard chemotherapy, hormonal, targeted, or immunotherapy medicines available in treating patients with solid tumors and hepatobiliary malignancies.
Not Available
I/II
Heumann, Thatcher
NCT04068194
VICC-NTGIT24020
