Clinical trials: sponsored by University of Florida
Neuroblastoma, Diffuse Intrinsic Pontine Glioma
PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy
A Phase I open-label, multicenter study, to evaluate the safety, feasibility, and maximum tolerated dose (MTD) of treating children with newly diagnosed DIPG or recurrent neuroblastoma with molecular targeted therapy in…
- Trial name
- PEACH (NCT04837547)
- Testing
- Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT)
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- University of Florida
Recurrent Group 3 Medulloblastoma, Recurrent Group 4 (Non-SHH/Non-WNT) Medulloblastoma
Adoptive T Cell Therapy, DC Vaccines, and Hematopoietic Stem Cells Combined With Immune checkPOINT Blockade in Patients With Medulloblastoma
This is a pilot study in a small number of children and young adults with suspected recurrent/progressive medulloblastoma (MB) looking at the feasibility and safety of adoptive cell therapy plus PD-1 blockade.
- Trial name
- MATCHPOINT (NCT06514898)
- Testing
- TTRNA-DC vaccines with GM-CSF, TTRNA-xALT, Td vaccine
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- University of Florida
Recurrent Pulmonary Osteosarcoma, Recurrent High-grade Glioma
RNA Lipid Particles Targeting Pediatric Recurrent Intracranial Malignancies and Other systEmic Solid Tumors
The Investigators have demonstrated in preclinical studies that RNA liposomes activate APCs, induce antigen-specific T cell immunity, and can supplant DCs in a cell therapy model for HGG and have shown feasibility and activity of…
- Trial name
- RNA PRIME (NCT05660408)
- Testing
- pp65 RNA LP (DP1), pp65/tumor mRNA RNA-LP (DP2), Surgical Biopsy/Resection
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- University of Florida
High-grade Glioma, Diffuse Intrinsic Pontine Glioma
IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Newly Diagnosed and Recurrent Pediatric High-grade Glioma (pHGG) and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (ndDIPG)
This is a phase I study to assess the safety and feasibility of IL-8 receptor modified patient-derived activated CD70 CAR T cell therapy in newly diagnosed and recurrent CD70+ Pediatric High-Grade Gliomas (pHGG) and Diffuse…
- Trial name
- Peds IMPACT (NCT06946680)
- Testing
- Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Florida
Acute Myeloid Leukemia, Acute Lymphoid Leukemia
Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)
This is a first in children prospective study of allogeneic hematopoietic cell transplant using a centrally manufactured engineered donor graft (Orca-Q).
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Mixed Phenotype Acute Leukemia, Acute Undifferentiated Leukemia
- Trial name
- NCT05322850
- Testing
- Orca-Q
- Where
- 4 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Florida
Adult Glioblastoma, High Grade Glioma
A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)
The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in (Stratum 1) adult patients with newly diagnosed GBM (MGMT low level or…
- Conditions
- Adult Glioblastoma, High Grade Glioma, WHO Grade III or IV Malignant Glioma
- Trial name
- PNOC020 (NCT04573140)
- Testing
- Autologous total tumor mRNA and pp65 full length (fl) lysosomal associated membrane protein (LAMP) mRNA loaded DOTAP liposome vaccine administered intravenously (RNA loaded lipid particles, RNA-LPs)
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- University of Florida
Duchenne Muscular Dystrophy
Tadalafil as Adjuvant Therapy for DMD
This project will assess the vascular responsiveness in leg muscles of boys with Duchenne muscular dystrophy (DMD) to one single dose of tadalafil, a common vasodilator drug, using non-invasive techniques (MRI or Doppler…
- Trial name
- NCT05195775
- Testing
- Tadalafil
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Florida
Duchenne Muscular Dystrophy, Duchenne Disease
Evaluating VM100 Nutritional Supplement for Improving Quality of Life in Duchenne Muscular Dystrophy Patients
This pilot study will investigate the potential efficacy of VM100, a nutritional supplement specifically formulated for patients with DMD, on quality of life and physical symptoms.
- Conditions
- Duchenne Muscular Dystrophy, Duchenne Disease, Muscular Dystrophy in Children, DMD
- Trial name
- NCT07766980
- Testing
- VM100 Nutritional Supplement
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Florida
Papillomavirus Vaccines
ReMARK: Addressing Disparities in Rural HPV-related Cancer Prevention
There are three main objectives of the protocol. First, we will evaluate the added clinical- and cost- effectiveness of parent-targeted motivational aids (reminder/recall and phone-based MI) alone and when combined with…
- Trial name
- NCT06535139
- Testing
- Brief training, Parent-targeted motivational aids, Healthcare access
- Where
- United States
- Volunteers
- 4,630 people
- Sponsor
- University of Florida
Friedreich's Ataxia
Biomarkers in Friedreich's Ataxia
The purpose of this project is to characterize measures of cardiac performance and neuromuscular physiology in FA patients using novel techniques, including echocardiography and magnetic resonance imaging (MRI), metabolic…
- Trial name
- NCT02497534
- Where
- United States
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- University of Florida
Recurrent Medulloblastoma
RNA-lipid Particle (RNA-LP) Vaccines for Recurrent/Progressive Medulloblastoma (MB)
The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in pediatric patients with recurrent/progressive Medulloblastoma (MB)
- Trial name
- PNOC020 rMB (NCT07492316)
- Testing
- Autologous total tumor mRNA and pp65 full length (fl) lysosomal associated membrane protein (LAMP) mRNA loaded DOTAP liposome vaccine administered intravenously (RNA loaded lipid particles, RNA-LPs)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Florida
Pregnancy, Post Partum
Deconstructing Maternal Burdens: Doulas and the Community Unite for Health
This study is a randomized controlled trial comparing two models of doula support for pregnant individuals enrolled in Medicaid: an enhanced doula support model, in which support starts earlier in pregnancy, occurs more…
- Conditions
- Pregnancy, Post Partum, Doula Care, Postpartum Depression (PPD)
- Trial name
- UNITE (NCT07799805)
- Testing
- Doula, Standard (non-enhanced) Medicaid doula support
- Where
- United States
- Volunteers
- 516 people
- Sponsor
- University of Florida
Recurrent Osteosarcoma
Single-Patient Expanded Access Protocol - RNA-LP in a Patient With Recurrent Osteosarcoma
Treatment of a patient with recurrent osteosarcoma with personalized pp65/tumor mRNA RNA-LP under an individual patient expanded access protocol.
- Trial name
- NCT07560709
- Testing
- pp65/tumor mRNA RNA-LP
- Where
- United States
- Sponsor
- University of Florida
Recurrent High-grade Glioma, Grade III Astrocytoma
Peds CHAMP1ON - Hematopoietic Stem Cell And Monoclonal Antibody PD-1 Blockade for RecurreNt Pediatric High-Grade Glioma
This is a Phase I study of ex vivo expanded CD34+ hematopoietic stem cells (exHSCs) plus nivolumab in pediatric patients with histologically confirmed diagnosis of a non-brainstem high-grade glioma (NB-HGG, WHO Grade III or IV…
- Conditions
- Recurrent High-grade Glioma, Grade III Astrocytoma, Oligodendroglioma, Oligoastrocytoma
- Trial name
- Peds CHAMP1ON (NCT07031765)
- Testing
- exHSC, Nivolumab, Resection or biopsy
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Florida
Seizures
Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
Approximately a fourth of children with seizures do not respond adequately to available therapy. Ketogenic therapy has a long history as treatment for intractable epilepsy, but there is no agreement concerning how it works and…
- Trial name
- NCT02216500
- Testing
- Ketogenic Therapy
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- University of Florida
Osteoarthritis, Osteosarcoma
Clinical Orthopaedic Data Bank (Acute and Chronic)
Data involving orthopaedic conditions and rehabilitation aspects of musculoskeletal and neuromuscular disorders will be collected and stored as part of the normal clinical care of patients seen in the University of Florida (UF)…
- Conditions
- Osteoarthritis, Osteosarcoma, Scoliosis, Cerebral Palsy
- Trial name
- NCT00411060
- Where
- United States
- Volunteers
- 10,000 people
- Sponsor
- University of Florida
Mental Health
Reducing Unmet Mental Health Need of African-American Children
The purpose of this study is to compare two versions of school-based mental health screening to improve the receipt of mental health services among elementary school students.
- Trial name
- NCT05450094
- Testing
- Screening Only, Enhanced Screening
- Where
- United States
- Volunteers
- 19,106 people, healthy volunteers welcome
- Sponsor
- University of Florida
Medulloblastoma, Neuroectodermal Tumor
Vaccine Immunotherapy for Recurrent Medulloblastoma and Primitive Neuroectodermal Tumor
Immunotherapy is a specific approach to treating cancer that has shown promise in adult patients for the treatment of melanoma, malignant brain tumors, and other cancers.
- Trial name
- Re-MATCH (NCT01326104)
- Testing
- TTRNA-xALT, TTRNA-DCs
- Where
- 3 sites in United States
- Volunteers
- 26 people
- Sponsor
- University of Florida
HPV
Text and Talk: A Multi-level Intervention to Increase Provider HPV Vaccine Recommendation Effectiveness
This study will test the effectiveness of two interventions (parent-targeted text messages and a brief clinician-targeted training) at increasing HPV vaccination among 11- to 12-year-olds living in Florida.
- Trial name
- Text&Talk (NCT05006833)
- Testing
- Brief Provider Training - Bundled Approach, Brief Provider Training - Benefits Approach, Parent Interactive Text Message - Bundled Approach
- Where
- United States
- Volunteers
- 8,043 people, healthy volunteers welcome
- Sponsor
- University of Florida
Mouth Abnormalities, Cleft Palate
Evaluation of Trigeminal Nerve Blockade
Cleft palate repair requires high doses of opioids for pain control postop. An alternative approach is placement of nerve blocks in the pterygopalatine fossa bilaterally, blocking the maxillary nerve \& covering the entire…
- Conditions
- Mouth Abnormalities, Cleft Palate, Birth Defect
- Trial name
- NCT03632044
- Testing
- Ropivacaine
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Florida