Clinical trials: Phase 1
Soft Tissue Sarcomas
Phase I Study of Safety and Feasibility of Transarterial Embolization of Incurable Hypervascular Pediatric Soft Tissue Sarcomas
This is a single center, single arm phase I clinical trial exploring the feasibility and safety of performing transarterial embolization of incurable hypervascular pediatric soft tissue sarcomas with at least an index tumor with…
- Trial name
- NCT07136571
- Testing
- bland particles
- Sponsor
- University of Alabama at Birmingham
Depression
Designing and Testing a Family Therapy for Adolescent Depression
This study will design and test a cognitive behavioral therapy for depressed adolescents that uses family interactions to help with treatment.
- Trial name
- NCT00867919
- Testing
- Behavioral Family Treatment, Community-based treatment as usual
- Where
- 2 sites in United States
- Volunteers
- 56 people
- Sponsor
- Oregon Research Institute
Asthma
Pharmacokinetic and Pharmacodynamic Profiles of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients With Asthma
The primary objective of this study is to compare the pharmacokinetic (PK) profiles of Albuterol Spiromax® and ProAir HFA after administration of a single inhaled dose of 180 mcg albuterol base from each product.
- Trial name
- NCT01844401
- Testing
- Albuterol Spiromax®, ProAir® HFA
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Juvenile Idiopathic Arthritis
A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17.
- Trial name
- JUVE-X (NCT03773965)
- Testing
- Baricitinib
- Where
- 78 sites in Argentina, Australia and 18 more
- Volunteers
- 190 people
- Sponsor
- Eli Lilly and Company
Advanced Cancers, Solid Tumors
Erlotinib in Combination With Pralatrexate in Advanced Malignancies
The goal of this clinical research study is to find the highest tolerable dose of the combination of erlotinib and pralatrexate that can be given to patients with advanced cancer.
- Trial name
- NCT01532011
- Testing
- Erlotinib, Pralatrexate
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- M.D. Anderson Cancer Center
Spinal Muscular Atrophy Type I
Study of Safety, Tolerability and Efficacy of GB221 in Infants With Spinal Muscular Atrophy Type 1
GB221 is a gene therapy that delivers a working SMN1 gene to the motor neurons of people with spinal muscular atrophy (SMA) Type 1. This study will evaluate the safety, tolerability and efficacy of GB221 in two groups: 1.
- Trial name
- NCT07070999
- Testing
- GB221
- Where
- Brazil
- Volunteers
- 22 people
- Sponsor
- Gemma Biotherapeutics
Duchenne Muscular Dystrophy
AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD)
RGX-202 is a gene therapy designed to deliver a transgene for a novel microdystrophin that includes functional elements of naturally-occurring dystrophin including the C-Terminal (CT) domain.
- Trial name
- NCT05693142
- Testing
- RGX-202
- Where
- 23 sites in United States, Canada
- Volunteers
- 65 people
- Sponsor
- REGENXBIO Inc.
Retinitis Pigmentosa (RP)
Prospective, Randomized, Sham-controlled, Dose-finding I/II Trial of Safety and Efficacy of Modified Optogenetic Gene Therapy (ZM-02 Injection)
This is a Phase 1/2, multi-center, randomized, sham-controlled, dose-escalation study evaluating ZM-02 in patients with advanced retinitis pigmentosa (RP).
- Trial name
- PRISM (NCT07282457)
- Testing
- ZM-02 (low dose), ZM-02 (high dose), ZM-02 (selected dose)
- Volunteers
- 21 people
- Sponsor
- Zhongmou Therapeutics
Solid Tumor Cancer, Medulloblastoma
Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).
Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed)
- Conditions
- Solid Tumor Cancer, Medulloblastoma, High Risk Neuroblastoma, High Grade Gliomas
- Trial name
- LUPARPED (NCT06607692)
- Testing
- Olaparib; 177Lu-DOTATATE
- Where
- Spain
- Volunteers
- 25 people
- Sponsor
- Fundación de investigación HM
Typhoid
Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine
This is a Phase I, Randomized, observer-blinded, age de-escalating study. The study objectives are: 1. To evaluate the safety of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and 4 weeks. 2.
- Trial name
- NCT02645032
- Testing
- Vi-DT, Typhim Vi®, VAXIGRIP®
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- International Vaccine Institute
FSHD - Facioscapulohumeral Muscular Dystrophy
Safety and Preliminary Efficacy of ULSC in Facioscapulohumeral Muscular Dystrophy (FSHD)
The goal of this clinical trial is to learn about how an umbilical cord lining-derived stem cell product (ULSC) performs when treating Facioscapulohumeral Muscular Dystrophy (FSHD) 1 or 2.
- Trial name
- NCT07086521
- Testing
- ULSC
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Restem, LLC.
Leukemia
A Phase 1 Study of CD22-CAR TCell Immunotherapy for CD22+ Leukemia and Lymphoma
Patients with relapsed or refractory leukemia often develop resistance to chemotherapy and some patients who relapse following CD19 directed therapy relapse with CD19 negative leukemia.
- Trial name
- PLAT-04 (NCT03244306)
- Testing
- Patient-derived CD22-specific CAR T-cells also expressing an EGFRt
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Seattle Children's Hospital
Leukemia, Lymphoma
Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease
RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer or abnormal cells.
- Conditions
- Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
- Trial name
- NCT00423826
- Testing
- Busulfan, Cytarabine, Fludarabine phosphate
- Where
- United States
- Sponsor
- Barbara Ann Karmanos Cancer Institute
Respiratory Syncytial Virus Infections
Open-Label, Dose-Escalation Study of 2 to 5 IM Doses of MEDI-524 at 3 mg/kg or 15 mg/kg; Children to be Followed for 90 Days After Their Last Dose of MEDI-524
MEDI-524 given for up to 5 doses at 3 and 15 mg/kg to high-risk children appeared to be safe and well tolerated.
- Trial name
- NCT00192478
- Testing
- Medi-524
- Where
- 3 sites in Argentina, Chile
- Volunteers
- 217 people
- Sponsor
- MedImmune LLC
Metastatic Myxoid Liposarcoma, Metastatic Round Cell Liposarcoma
Testing the Combination of Two Experimental Drugs MK-3475 (Pembrolizumab) and Interferon-gamma for the Treatment of Mycosis Fungoides and Sézary Syndrome and Advanced Synovial Sarcoma
This phase II trial studies how well pembrolizumab and interferon gamma-1b work in treating patients with stage IB-IVB mycosis fungoides and Sezary syndrome that has come back (relapsed) or has not responded to previous treatment…
- Conditions
- Metastatic Myxoid Liposarcoma, Metastatic Round Cell Liposarcoma, Metastatic Synovial Sarcoma, Recurrent Mycosis Fungoides and Sezary Syndrome
- Trial name
- NCT03063632
- Testing
- Interferon Gamma-1b, Laboratory Biomarker Analysis, Pembrolizumab
- Where
- 7 sites in United States
- Volunteers
- 28 people
- Sponsor
- National Cancer Institute (NCI)
Myopia, Cornea
Euclid Phoenix Lens Design Trial
The "first fit" success rate of the current Euclid orthokeratology "MAX" lens design will be compared to that of the new Euclid orthokeratology MAX "Phoenix" lens design in 30 children.
- Trial name
- NCT06389916
- Testing
- Euclid orthokeratology MAX (current design), Euclid orthokeratology MAX Phoenix (new design)
- Where
- 5 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Euclid Systems Corporation
Infections, Meningococcal
Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT (GSK134612) in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Prevenar 13™Vaccine
The purpose of this study is to compare the immediate and long term (up to 5 years) immunogenicity and safety of GSK Biologicals' MenACWY-TT vaccine when given as a single dose or as 2 doses to toddlers aged 12 to 14 months.
- Trial name
- NCT01939158
- Testing
- Meningococcal vaccine GSK134612, Prevenar 13™
- Where
- 51 sites in Australia, Canada and 4 more
- Volunteers
- 803 people, healthy volunteers welcome
- Sponsor
- Pfizer
Herpes Simplex, HIV Infections
A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS
To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for refractory mucocutaneous herpes simplex virus disease in AIDS patients.
- Trial name
- NCT00002116
- Testing
- Cidofovir
- Where
- 9 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Gilead Sciences
Bacterial Infections
Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections
Adolescent subjects hospitalized for the treatment of bacterial infections will be given 1 gram of dalbavancin through their veins and levels of dalbavancin in blood and urine will be measured at different time points.
- Trial name
- NCT00678106
- Testing
- Dalbavancin
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Pfizer
Glial Tumor of Brain, Diffuse Intrinsic Pontine Glioma
Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma
The primary aim of this study is to determine the presence of gemcitabine in childhood diffuse midline gliomas (DMG) (previously classified as diffuse intrinsic pontine glioma [DIPG]) after systemic treatment with the drug.
- Conditions
- Glial Tumor of Brain, Diffuse Intrinsic Pontine Glioma, Glioma
- Trial name
- NCT04051047
- Testing
- Gemcitabine, Tumor biopsy and blood draw
- Where
- United States
- Sponsor
- University of Michigan Rogel Cancer Center
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