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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)

Miscellaneous

This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo
given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous
cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with
radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in
increasing recurrence free survival (RFS).
Miscellaneous
III
Choe, Jennifer
NCT03833167
VICCHN18177

ILND Surgery Alone or after Chemotherapy with or without Radiation Therapy in Treating Patients with Advanced Penile Cancer

Miscellaneous

This phase III trial studies how well inguinal lymph node dissection (ILND) surgery alone or after chemotherapy with or without intensity-modulated radiation therapy works in treating patients with penile cancer that has spread to other places in the body. Surgery is used to remove the lymph nodes and may be able to cure the cancer. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, 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. Intensity-modulated radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. It is not known whether having surgery after chemotherapy with or without radiation therapy is better than having surgery alone.
Miscellaneous
III
Rini, Brian
NCT02305654
ECOGUROEA8134

LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis

Multiple Cancer Types

The LCH-IV is an international, multicenter, prospective clinical study for pediatric
Langerhans Cell Histiocytosis LCH (age < 18 years).
Miscellaneous, Pediatrics
III
Pastakia, Devang
NCT02205762
VICCPED2231

Study of DF1001 in Patients With Advanced Solid Tumors

Multiple Cancer Types

DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell
activation signals to specific receptors on cancer cells. The study will occur in two phases.
The first phase will be a dose escalation phase, enrolling patients with various types of
solid tumors that express human epidermal growth factor receptor 2 (HER2). The second phase
will include a dose expansion using the best dose selected from the first phase of the study.
Multiple cohorts will be opened with eligible patients having either HER2 activated non-small
cell lung cancer, hormone receptor (HR) positive HER2 negative metastatic breast cancer, or
HER2 positive metastatic breast cancer. DF1001-001 will be administered as monotherapy or in
combination; combinations are DF1001 + nivolumab, DF1001 + Nab paclitaxel, and DF1001 +
sacituzumab govitecan-hziy.
Miscellaneous, Phase I
I/II
Berlin, Jordan
NCT04143711
VICCPHI2064

Ensartinib in Treating Patients with Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders with ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)

Multiple Cancer Types

This phase II Pediatric MATCH trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that have come back (recurrent) or does not respond to treatment (refractory) and may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Germ Cell (Pediatrics), Miscellaneous, Neuroblastoma (Pediatrics), Pediatric Lymphoma, Pediatric Solid Tumors, Pediatrics, Wilms / Other Kidney (Pediatrics)
II
Borinstein, Scott
NCT03213652
COGAPEC1621F

MRI and 18F-Fluoromisonidazole PET/CT Scan for Assessing Tumor Hypoxia and Guiding Adaptive Radiation Therapy in Patients With Head and Neck Cancer or Brain Metastases

Miscellaneous

This clinical trial is studying how well magnetic resonance imaging (MRI) in combination with 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET)/computed tomography (CT) scans works in assessing a decrease in the amount of oxygen (hypoxia) in tumor cells and in guiding adaptive radiation treatment in patients with head and neck cancer or cancer that has spread to the brain from where it first started (brain metastasis). Both head and neck cancer and brain metastases can be treated with radiation. Previous research studies have shown that the amount of oxygen that goes towards cancer cells prior to their radiation treatments predicts how the cancer cells will respond to radiation treatment. MRI is a type of imaging technique that uses radio waves and large magnets to produce detailed images of areas inside the body. 18F-FMISO is a radioactive substance that binds to hypoxic tumor cells and emits radiation, allowing the tumor cells to be visualized using PET/CT, which is an imaging technique that combines PET and CT in a single machine. It is used to make detailed, computerized images of inside the body. By combining MRI with 18F-FMISO PET/CT, researchers may be able to develop an MRI sequence that can be used to evaluate hypoxia in tumor cells and predict response to treatment in patients with head and neck cancer or brain metastases.
Miscellaneous
Early I
De vis, Jill
NCT05996432
VICC-EDMDT23195

Educational Telehealth Program for the Delivery of Care to Cancer Patients in Rural Communities, ENCORE Study

Miscellaneous

This clinical trial evaluates the clinical effectiveness of a multi-level telehealth-based intervention for cancer patients in rural communities. Rural residents face limited accessibility to cancer treatment and supportive care services, transportation barriers, and financial issues. Cancer Thriving and Surviving is an evidence-based self-management intervention with demonstrated efficacy across numerous chronic health conditions with dissemination across the US, inclusive of rural communities. This trial evaluates whether the evidence-based Cancer Thriving and Surviving intervention delivered through telehealth among rural patients may improve patient outcomes.
Miscellaneous
N/A
Friedman, Debra
NCT04758338
VICCPED2013

Treatment Response and Biomarker-Guided Steroid Taper for Children with GVHD

Multiple Cancer Types

This phase II trial studies the treatment response for patients with acute graft-versus-host disease (GVHD). GVHD occurs when donor immune cells attack the healthy tissue of a bone marrow or stem cell transplant patient. The standard treatment for GVHD is to lower the activity of the donor cells by using steroid medications such as prednisone. But steroid treatment may cause many complications and the risk of these complications increases with higher doses of steroids and longer treatment. It is important to find ways to decrease the steroid treatment in patients who do not need long courses. Researchers are doing this study to find out how many subjects respond well to lower steroid dosing based on a blood test (GVHD biomarker) and if they develop fewer complications.
Miscellaneous, Pediatrics
II
Kitko, Carrie
NCT05090384
VICCPED2213

Prophylactic Reinforcement of Ventral Abdominal Incisions Trial

Miscellaneous

This trial is being conducted to evaluate the efficacy of Phasix Mesh implantation at the
time of midline fascial closure compared to primary suture closure in preventing a subsequent
incisional hernia in subjects at risk for incisional hernia after open midline laparotomy
surgery.
Miscellaneous
IV
Pierce, Richard
NCT03911700
VICCGI2281

Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients with Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)

Multiple Cancer Types

This Pediatric MATCH screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.
Lymphoma, Miscellaneous, Pediatric Solid Tumors
N/A
Borinstein, Scott
NCT03155620
COGAPEC1621SC

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