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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



Testing the use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy with Docetaxel plus Trastuzumab) for Recurrent, Metastatic, or Unresectable HER2-Positive Salivary Gland Cancer

Head/Neck

This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-positive salivary gland cancer that has come back (recurrent), that has spread from where it first started (primary site) to other places in the body, or cannot be removed by surgery (unresectable). Trastuzumab is a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by body's immune system. Trastuzumab emtansine contains trastuzumab, linked to a chemotherapy drug called emtansine. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers emtansine to kill them. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Trastuzumab emtansine may work better compared to usual treatment of chemotherapy with docetaxel and trastuzumab in treating patients with recurrent, metastatic or unresectable salivary gland cancer.
Head/Neck
II
Choe, Jennifer
NCT05408845
NRGHN010

Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy with Radiation after Surgery for Recurrent Head and Neck Squamous Cell Carcinoma

Head/Neck

This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy [cisplatin and carboplatin] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is also in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma.
Head/Neck
II
Choe, Jennifer
NCT04671667
ECOGHNEA3191

A Study of a New Way to Treat Children and Young Adults with a Brain Tumor Called NGGCT

Multiple Cancer Types

This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patients response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, 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 or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT.
Germ Cell (Pediatrics), Pediatrics
II
Esbenshade, Adam
NCT04684368
COGACNS2021

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

A Study of Combination Chemotherapy for Patients with Newly Diagnosed DAWT and Relapsed FHWT

Multiple Cancer Types

This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) 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. This trial may help doctors find out what effects, good and/or bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE/Cyclo/Topo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).
Pediatrics, Wilms / Other Kidney (Pediatrics)
II
Benedetti, Daniel
NCT04322318
COGAREN1921

Study of INBRX-109 in Conventional Chondrosarcoma

Sarcoma

Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or
metastatic conventional chondrosarcoma patients.
Sarcoma
II
Davis, Elizabeth
NCT04950075
VICCSAR2165

Evolutionary Inspired Therapy for the Treatment of Fusion Positive Newly Diagnosed, Metastatic Rhabdomyosarcoma

Multiple Cancer Types

This phase II trial investigates evolutionary inspired therapy in treating fusion positive rhabdomyosarcoma that is newly diagnosed and has spread to other places in the body (metastatic). Chemotherapy drugs, such as vinorelbine, vincristine sulfate, and actinomycin D, 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. Cyclophosphamide is used to decrease the body's immune response and may inhibit DNA replication and initiate cell death. This study is being done to determine which of 4 different therapeutic treatments will have the best chance of the disease not worsening or coming back.
Pediatrics, Sarcoma
II
Borinstein, Scott
NCT04388839
VICCPED2134

Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

Sarcoma

This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A*02 eligible and
MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort
1, 2 and 3 ) or MRCLS (Cohort 1) .
Sarcoma
II
Keedy, Vicki
NCT04044768
VICCSAR1948

Testing Atezolizumab Alone or Atezolizumab Plus Bevacizumab in People with Advanced Alveolar Soft Part Sarcoma

Sarcoma

This phase II trial studies how well atezolizumab or atezolizumab plus bevacizumab works in treating patients with alveolar soft part sarcoma that has not been treated, has spread from where it started to other places in the body (advanced) and cannot be removed by surgery (unresectable). Atezolizumab works by unblocking the immune system, allowing the immune system cells to recognize and then attack tumor cells. Bevacizumab works by controlling the growth of new blood vessels. Giving atezolizumab alone or atezolizumab with bevacizumab may shrink the cancer.
Sarcoma
II
Davis, Elizabeth
NCT03141684
VICCSAR16155ET-CT

HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide

Multiple Cancer Types

This is a prospective, multi-center, Phase II study of hematopoietic cell transplantation
(HCT) using human leukocyte antigen (HLA)-mismatched unrelated donors (MMUD) for peripheral
blood stem cell transplant in adults and bone marrow stem cell transplant in children.
Post-transplant cyclophosphamide (PTCy), tacrolimus and mycophenolate mofetil (MMF) will be
used for for graft versus host disease (GVHD) prophylaxis. This trial will study how well
this treatment works in patients with hematologic malignancies.
Hematologic, Leukemia, Lymphoma, Myelodysplastic Syndrome
II
Dholaria, Bhagirathbhai
NCT04904588
VICCCTT2171

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