Search Clinical Trials
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Palliative Spatially Fractionated (GRID) Radiotherapy Using Intensity Modulated Proton Therapy
Washington University School of Medicine
Unresectable Solid Tumor
Metastatic Cancer
Spatially fractionated radiotherapy (SFRT or GRID) addresses some limitations of
traditional stereotactic body radiation therapy by relying on beam collimation to create
high-dose "peaks" and intervening low-dose "valleys" throughout the target volume.
Standard palliative radiotherapy regimens prov1 expand
Spatially fractionated radiotherapy (SFRT or GRID) addresses some limitations of traditional stereotactic body radiation therapy by relying on beam collimation to create high-dose "peaks" and intervening low-dose "valleys" throughout the target volume. Standard palliative radiotherapy regimens provide limited durability of response, and there are challenges with delivery to large tumors or in previously irradiated fields. In this study, Proton GRID radiotherapy will be used to deliver three-fraction palliative radiotherapy to patients with tumors needing palliative radiation. The safety and efficacy of this approach will be assessed. It is hypothesized that GRID is highly effective, immunogenic, and associated with low rates of toxicity. Type: Interventional Start Date: May 2023 |
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Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety an1
National Cancer Institute (NCI)
Advanced Malignant Solid Neoplasm
Advanced Microsatellite Stable Colorectal Carcinoma
Hematopoietic and Lymphatic System Neoplasm
Metastatic Malignant Solid Neoplasm
Metastatic Microsatellite Stable Colorectal Carcinoma
This phase I/II trial studies the side effects and best dose of temozolomide and M1774
and how well they works in treating patients with cancer that has spread from where it
first started (primary site) to other places in the body (metastatic) and may have spread
to nearby tissue, lymph nodes, or d1 expand
This phase I/II trial studies the side effects and best dose of temozolomide and M1774 and how well they works in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and may have spread to nearby tissue, lymph nodes, or distant parts of the body (advanced). Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells and slow down or stop tumor growth. M1774 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Adding M1774 to temozolomide may shrink or stabilize cancer for longer than temozolomide alone. Type: Interventional Start Date: Sep 2023 |
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MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults Wit1
Perspective Therapeutics
Recurrent Melanoma (Skin)
Metastatic Melanoma
Melanoma Stage IV
Melanoma Stage III
In this first-in human, phase I/IIa study, the safety and efficacy of [212Pb]VMT01, an
alpha-particle emitting therapeutic agent targeted to melanocortin sub-type 1 receptor
(MC1R) is being evaluated as a monotherapy and in combination with nivolumab in subjects
with unresectable and metastatic mel1 expand
In this first-in human, phase I/IIa study, the safety and efficacy of [212Pb]VMT01, an alpha-particle emitting therapeutic agent targeted to melanocortin sub-type 1 receptor (MC1R) is being evaluated as a monotherapy and in combination with nivolumab in subjects with unresectable and metastatic melanoma. Type: Interventional Start Date: Jun 2023 |
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SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)
Nuvation Bio Inc.
Glioma
Astrocytoma, Grade IV
IDH1-mutant Glioma
Astrocytoma, IDH-Mutant, Grade 3
Astrocytoma, IDH-Mutant, Grade 4
This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy,
safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with
recurrent/progressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3
glioma.
The purpose of Part 2 will be to1 expand
This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent/progressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma. The purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 2 or Grade 3 astrocytoma with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double-blind, and placebo-controlled. The purpose of Part 3 will be to evaluate the efficacy of safusidenib in participants with residual or recurrent IDH1-mutant Grade 3 oligodendroglioma who have received surgery as their only treatment. Part 3 will be an open-label single-arm cohort and will enroll participants concurrently with Part 2. Type: Interventional Start Date: Jun 2023 |
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BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With A1
National Cancer Institute (NCI)
Clinical Stage III Cutaneous Melanoma AJCC v8
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Clinical Stage IV Cutaneous Melanoma AJCC v8
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Locally Recurrent Head and Neck Squamous Cell Carcinoma
This phase II trial studies the good and bad effects of the combination of drugs called
cabozantinib and nivolumab in treating patients with melanoma or squamous cell head and
neck cancer that may have spread from where it first started to nearby tissue, lymph
nodes, or distant parts of the body (a1 expand
This phase II trial studies the good and bad effects of the combination of drugs called cabozantinib and nivolumab in treating patients with melanoma or squamous cell head and neck cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. This trial may help doctors determine how quickly patients can be divided into groups based on biomarkers in their tumors. A biomarker is a biological molecule found in the blood, other body fluids, or in tissues that is a sign of a normal or abnormal process or a sign of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. The two biomarkers that this trial is studying are "tumor mutational burden" and "tumor inflammation signature." Another purpose of this trial is to help doctors learn if cabozantinib and nivolumab shrink or stabilize the cancer, and whether patients respond differently to the combination depending on the status of the biomarkers. Type: Interventional Start Date: Dec 2022 |
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Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy
Washington University School of Medicine
Prostate Cancer
Prostate Neoplasm
The purpose of this research study is to learn more about the outcomes and early and late
side effects of treating early stage prostate cancer with high dose rate brachytherapy. expand
The purpose of this research study is to learn more about the outcomes and early and late side effects of treating early stage prostate cancer with high dose rate brachytherapy. Type: Interventional Start Date: Feb 2018 |
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Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases
Washington University School of Medicine
Metabolic Disorders
Hematologic, Immune, or Bone Marrow Disorders
Hemoglobinopathies
Non-malignant Disorders
The hypothesis for this study is that a preparative regimen that maximizes host
immunosuppression without myeloablation will be well tolerated and sufficient for
engraftment of donor hematopoietic cells. It is also to determine major toxicities from
these conditioning regimens, within the first 1001 expand
The hypothesis for this study is that a preparative regimen that maximizes host immunosuppression without myeloablation will be well tolerated and sufficient for engraftment of donor hematopoietic cells. It is also to determine major toxicities from these conditioning regimens, within the first 100 days after transplantation. Type: Interventional Start Date: Dec 2001 |
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Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REG1
National Cancer Institute (NCI)
Locally Advanced Adrenal Cortical Carcinoma
Metastatic Adrenal Cortical Carcinoma
Recurrent Adrenal Cortical Carcinoma
Stage III Adrenal Cortical Carcinoma AJCC v8
Stage IV Adrenal Cortical Carcinoma AJCC v8
This phase II trial compares the effect of giving cabozantinib with or without cemiplimab
in patients with adrenocortical cancer that has spread to nearby tissue or lymph nodes
(locally advanced), and that cannot be removed by surgery (unresectable) or that has come
back after a period of improveme1 expand
This phase II trial compares the effect of giving cabozantinib with or without cemiplimab in patients with adrenocortical cancer that has spread to nearby tissue or lymph nodes (locally advanced), and that cannot be removed by surgery (unresectable) or that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Cabozantinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib with cemiplimab may kill more tumor cells in patients with locally advanced unresectable or recurrent/metastatic adrenocortical cancer. Type: Interventional Start Date: Feb 2026 |
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Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Famil1
Novartis Pharmaceuticals
Familial Hypercholesterolemia - Homozygous
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy
of inclisiran in children (aged 2 to <12 years) with homozygous familial
hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDLC). expand
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 2 to <12 years) with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDLC). Type: Interventional Start Date: Feb 2025 |
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A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants1
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Multiple Sclerosis
Myasthenia Gravis
The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug
levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS),
Progressive Forms of Multiple Sclerosis (PMS) or Refractory Myasthenia Gravis (MG). expand
The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS) or Refractory Myasthenia Gravis (MG). Type: Interventional Start Date: Mar 2024 |
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Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on1
National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1-infection
The purpose of this study is to evaluate the safety, tolerability, and efficacy of
therapeutic vaccination with chimpanzee adenovirus ChAdOx1- and poxvirus modified
vaccinia Ankara (MVA)-vectored conserved mosaic T-cell vaccines in a sequential regimen
with the toll-like receptor 7 (TLR7) agonist v1 expand
The purpose of this study is to evaluate the safety, tolerability, and efficacy of therapeutic vaccination with chimpanzee adenovirus ChAdOx1- and poxvirus modified vaccinia Ankara (MVA)-vectored conserved mosaic T-cell vaccines in a sequential regimen with the toll-like receptor 7 (TLR7) agonist vesatolimod (VES) and two broadly neutralizing antibodies (bNAbs) compared to placebo, to induce HIV-1 control during analytic treatment interruption (ATI). Type: Interventional Start Date: Apr 2024 |
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Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
University of Alabama at Birmingham
Respiratory Syncytial Virus Infections
The overarching hypothesis of the ARRC trial is that administration of Azithromycin (AZM)
during acute, Respiratory Syncytial Virus (RSV)-induced respiratory failure will be
beneficial, mediated through the matrix metalloproteinase (MMP)-9 pathway. expand
The overarching hypothesis of the ARRC trial is that administration of Azithromycin (AZM) during acute, Respiratory Syncytial Virus (RSV)-induced respiratory failure will be beneficial, mediated through the matrix metalloproteinase (MMP)-9 pathway. Type: Interventional Start Date: Feb 2022 |
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The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation
Integra LifeSciences Corporation
Supratentorial Hemorrhage
This registry will study the use of the Aurora® Surgiscope to provide surgical access and
visualization in minimally invasive removal of hematoma in the brain. Many methods of
hematoma removal are available and will be based on surgeon preference. The impact of
patient selection and time to surgery1 expand
This registry will study the use of the Aurora® Surgiscope to provide surgical access and visualization in minimally invasive removal of hematoma in the brain. Many methods of hematoma removal are available and will be based on surgeon preference. The impact of patient selection and time to surgery from last known well time will be explored. Type: Observational Start Date: Oct 2020 |
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A Randomized Trial to Evaluate Sequential vs Simultaneous Patching
Jaeb Center for Health Research
Amblyopia
A randomized trial to determine whether simultaneous treatment with spectacles and
patching has an equivalent VA outcome compared with sequential treatment, first with
spectacles alone followed by patching (if needed), for previously untreated amblyopia in
children 3 to <13 years of age. expand
A randomized trial to determine whether simultaneous treatment with spectacles and patching has an equivalent VA outcome compared with sequential treatment, first with spectacles alone followed by patching (if needed), for previously untreated amblyopia in children 3 to <13 years of age. Type: Interventional Start Date: Dec 2020 |
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Ultrasound and Photoacoustic Imaging for Enhanced Differential Diagnosis of Rectal Cancer
Washington University School of Medicine
Rectal Cancer
Colorectal Cancer
The purpose of this study is to demonstrate the functionality of a novel endorectal
photoacoustic ultrasound imaging modality in humans with rectal cancer. The study
involves testing a previously developed endorectal device to determine its ability to
accurately assess rectal tumor response to preo1 expand
The purpose of this study is to demonstrate the functionality of a novel endorectal photoacoustic ultrasound imaging modality in humans with rectal cancer. The study involves testing a previously developed endorectal device to determine its ability to accurately assess rectal tumor response to preoperative treatment. Investigators hypothesize that a co-registered photoacoustic ultrasound endorectal device can significantly reduce unnecessary surgeries in rectal cancer patients with complete clinical response while maintaining high sensitivity in identifying those with residual cancer. Type: Interventional Start Date: May 2023 |
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Longitudinal Early-onset Alzheimer's Disease Study Protocol
Indiana University
Early Onset Alzheimer Disease
Alzheimer Disease
Mild Cognitive Impairment
The Longitudinal Early-onset Alzheimer's Disease Study (LEADS) is a non-randomized,
natural history, non-treatment study designed to look at disease progression in
individuals with early onset cognitive impairment. Clinical, cognitive, imaging,
biomarker, and genetic characteristics will be assesse1 expand
The Longitudinal Early-onset Alzheimer's Disease Study (LEADS) is a non-randomized, natural history, non-treatment study designed to look at disease progression in individuals with early onset cognitive impairment. Clinical, cognitive, imaging, biomarker, and genetic characteristics will be assessed across three cohorts: (1) early onset Alzheimer's Disease (EOAD) participants, (2) early onset non-Alzheimer's Disease (EOnonAD) participants, and (3) cognitively normal (CN) control participants. Type: Observational Start Date: Apr 2018 |
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Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue1
Washington University School of Medicine
Metastatic Soft-tissue Sarcoma
The investigators hypothesize that zanzalintinib in combination with ipilimumab and
nivolumab will be well tolerated and serve as a potential therapeutic strategy in
metastatic soft tissue sarcoma (mSTS) including myxofibrosarcoma, undifferentiated
pleomorphic sarcoma, dedifferentiated liposarcoma,1 expand
The investigators hypothesize that zanzalintinib in combination with ipilimumab and nivolumab will be well tolerated and serve as a potential therapeutic strategy in metastatic soft tissue sarcoma (mSTS) including myxofibrosarcoma, undifferentiated pleomorphic sarcoma, dedifferentiated liposarcoma, cutaneous angiosarcoma, and undifferentiated sarcoma histologies. Type: Interventional Start Date: Jan 2026 |
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SLV-154 Treatment of Metastatic Solid Tumors
Solve Therapeutics
Squamous Cell Cancer of Head and Neck (SCCHN)
NSCLC
SCLC
Cervical Cancer Metastatic
Breast Cancer Metastatic
This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics,
pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of dose levels
when administered to subjects with metastatic solid tumors. expand
This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of dose levels when administered to subjects with metastatic solid tumors. Type: Interventional Start Date: May 2025 |
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A Phase 1/2, First-in-Human Study On ODM-212 In Subjects With Selected Advanced Solid Tumours
Orion Corporation, Orion Pharma
Solid Tumours
Multi-site, open-label, first-in-human study with 2 parts (dose escalation and dose
expansion) in subjects with selected advanced solid tumours expand
Multi-site, open-label, first-in-human study with 2 parts (dose escalation and dose expansion) in subjects with selected advanced solid tumours Type: Interventional Start Date: Oct 2023 |
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Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/1
National Cancer Institute (NCI)
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements
Recurrent Diffuse Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type
Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and
Revlimid® (ViPOR) works in treating patients with CD10 negative diffuse large B-cell
lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come
back after a period of improvement (re1 expand
This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid® (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and/or that has not responded to previous treatment (refractory). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Obinutuzumab, a monoclonal antibody, binds to a protein called CD20, which is found on B cells and some types of leukemia and lymphoma cells. Obinutuzumab may block CD20 and help the immune system kill cancer cells. Revlimid, a type of anti-angiogenesis agent and a type of immunomodulating agent, may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that cancers need to grow. ViPOR may be an effective treatment option for patients with relapsed and/or refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements. Type: Interventional Start Date: Oct 2025 |
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Ultra-Hypofractionated vs. Hypofractionated Radiation for Node-Positive Breast Cancer
Washington University School of Medicine
Node-positive Breast Cancer
In breast cancer patients with nodal involvement, numerous studies have demonstrated that
adjuvant radiation therapy reduces the risk of local recurrence, regional recurrence, and
distant metastases, in addition to improving survival. The dose and fractionation for
adjuvant breast radiation therapy1 expand
In breast cancer patients with nodal involvement, numerous studies have demonstrated that adjuvant radiation therapy reduces the risk of local recurrence, regional recurrence, and distant metastases, in addition to improving survival. The dose and fractionation for adjuvant breast radiation therapy has evolved over time, as novel schedules have been compared to the current standard of care. Hypofractionated radiation therapy (266 cGy per fraction x 15-16 fractions over 3 weeks) has been shown to result in equivalent oncologic outcomes, as well as equivalent acute and late toxicity, when compared to standard fractionation (200 cGy per fraction x 25 fractions over 5 weeks). Subsequently, hypofractionated breast radiation has become the current standard of care. More recently, ultra-hypofractionated breast radiation (520 cGy per fraction x 5 fractions over 1 week) was shown in a randomized trial to be non-inferior to hypofractionated radiation when treating the breast after lumpectomy. However, the efficacy and toxicity of using ultra-hypofractionated radiation therapy when also treating the regional nodes has not been reported. This is important, as there is greater radiation exposure to several normal tissues, such as the arm/shoulder, brachial plexus, normal lymphatics, heart, and lung, when treating the regional nodes. In this randomized study, the investigators aim to compare the tolerability and efficacy of ultra-hypofractionated breast/chest wall and regional nodal radiation (SWIFT RT) against hypofractionated radiation (RT). The investigators will evaluate acute and late toxicity, oncologic outcomes (including local recurrence, regional recurrence, distant metastasis, and overall survival), cosmesis, and patient-reported quality of life. The investigators will collect blood samples for correlative studies of biomarkers of fibrosis and cardiac toxicity. Type: Interventional Start Date: Aug 2024 |
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A Trial Evaluating the Effect of NIO752 on Tau Synthesis Measured by a Process Known as SILK
University College, London
Alzheimer Disease
Autosomal Dominant Alzheimer Disease Due to Mutation of Presenilin 1 (Disorder)
Autosomal Dominant Alzheimer Disease Due to Mutation of Presenilin 2 (Disorder)
Autosomal Dominant Alzheimer Disease Due to Mutation of Amyloid Precursor Protein (Disorder)
This study will assess if drug (NIO752) reduces production of a protein, tau, by the
brain. Normally tau maintains the internal skeleton of nerve cells. In Alzheimer's
disease (AD) it builds up in the brain, causing damage. Abnormal tau proteins cling to
each other forming 'tangles' inside nerve ce1 expand
This study will assess if drug (NIO752) reduces production of a protein, tau, by the brain. Normally tau maintains the internal skeleton of nerve cells. In Alzheimer's disease (AD) it builds up in the brain, causing damage. Abnormal tau proteins cling to each other forming 'tangles' inside nerve cells, which interfere with how the nerve cells work, and eventually die. This is what causes the symptoms of dementia. It is thought that NIO752 reduces production of tau. Type: Interventional Start Date: Nov 2024 |
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A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
MeiraGTx, LLC
Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands
This study will assess the efficacy and safety of bilateral intra-parotid administration
of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia. expand
This study will assess the efficacy and safety of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia. Type: Interventional Start Date: Jun 2023 |
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A Multi-Institution Study of TGFβ Imprinted, Ex Vivo Expanded Universal Donor NK Cell Infusions as1
Nationwide Children's Hospital
Pediatric Sarcoma, Refractory
Pediatric Sarcoma, Relapsed
The purpose of this study is to determine if the addition of infusions of a type of
immune cell called a "natural killer", or NK cell to the sarcoma chemotherapy regimen
GEM/DOX (gemcitabine and docetaxel) can improve outcomes in people with childhood
sarcomas that have relapsed or not responded to1 expand
The purpose of this study is to determine if the addition of infusions of a type of immune cell called a "natural killer", or NK cell to the sarcoma chemotherapy regimen GEM/DOX (gemcitabine and docetaxel) can improve outcomes in people with childhood sarcomas that have relapsed or not responded to prior therapies. The goals of this study are: - To determine the safety and efficacy of the addition of adoptive transfer of universal donor, TGFβ imprinted (TGFβi), expanded NK cells to the pediatric sarcoma salvage chemotherapeutic regimen gemcitabine/docetaxel (GEM/DOX) for treatment of relapsed and refractory pediatric sarcomas To determine the 6-month progression free survival achieved with this treatment in patients within cohorts of relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma. - To identify toxicities related to treatment with GEM/DOX + TGFβi expanded NK cells Participants will receive study drugs that include chemotherapy and NK cells in cycles; each cycle is 21 days long and you can receive up to 8 cycles. - Gemcitabine (GEM): via IV on Days 1 and 8 - Docetaxel (DOX): via IV on Day 8 - Prophylactic dexamethasone: Day 7-9 to prevent fluid retention and hypersensitivity reaction - Peg-filgrastim (PEG-GCSF) or biosimilar: Day 9 to help your white blood cell recover and allow more chemotherapy to be given - TGFβi NK cells: via IV on Day 12 Type: Interventional Start Date: Nov 2022 |
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Obeticholic Acid for Prevention in Barrett's Esophagus
National Cancer Institute (NCI)
Barrett Esophagus
Esophageal Adenocarcinoma
This phase II trial studies the effect of obeticholic acid in treating patients with
Barrett's esophagus. Bile acids present in duodenogastroesophageal reflux contribute to
neoplastic progression in Barrett's esophagus. Obeticholic acid has shown
anti-cholestatic, anti-inflammatory and anti-fibroti1 expand
This phase II trial studies the effect of obeticholic acid in treating patients with Barrett's esophagus. Bile acids present in duodenogastroesophageal reflux contribute to neoplastic progression in Barrett's esophagus. Obeticholic acid has shown anti-cholestatic, anti-inflammatory and anti-fibrotic effects mediated by FXR activation. It down regulates bile acid availability and decreases proinflammatory cytokine production including IL-1beta and TNFalpha in human enterocytes and immune cells. This chain of events reduces the bile acid exposure in esophagus tissue thereby limiting bile acid induced damage and dysplastic progression. Type: Interventional Start Date: Jan 2024 |