Madera

Researchers are evaluating a new vaccine called V118C designed to help prevent pneumococcal disease, an infection caused by Streptococcus pneumoniae bacteria. This clinical trial focuses on infants and toddlers to assess how safe and well-tolerated V118C is in young children. The study is a Phase 1, randomized, double-blind trial comparing V118C with an existing vaccine called PCV20. The study is divided into two stages. Stage 1 involves toddlers aged 12 to 15 months who have already received a primary series of three doses of PCV vaccine they will receive a single dose of either V118C or PCV20. Stage 2 includes infants starting at approximately 2 months old who will receive four doses three infant doses plus one toddler dose of either V118C or PCV20. All doses are given as 0.5 mL intramuscular injections. Participants will be monitored closely for adverse events immediately after vaccination, as well as for up to 12 months postvaccination. Researchers will collect blood samples to measure immune responses to the vaccines. They will track both injection site and systemic reactions, serious adverse events, and medically attended events. The study aims to understand both safety and immune response profiles of V118C compared to PCV20 over the course of the dosing schedules and follow-up periods.

Researchers are evaluating a culturally-tailored home-based physical activity program designed for Hispanic or LatinoLatina adolescent and young adult childhood cancer survivors. These survivors may face long-term effects like weight gain, fatigue, and reduced physical fitness after cancer treatment. The study aims to see if this culturally-relevant program can help increase physical activity and improve overall health compared to using a Fitbit tracker alone. The study has two stages. In Stage 1, 20 Latinx survivors participate in developing the intervention using Fitbit trackers, text messages, social media support, wearable activity devices, and interviews over 9 months. In Stage 2, 170 survivors who do not meet physical activity guidelines are randomized to either the intervention group, which includes Fitbit use, weekly goal-setting, peer support via social media and Zoom meetings, and optional activity partners, or a control group that only uses Fitbit trackers for 12 weeks. The intervention includes an intensive phase with weekly sessions followed by a 4-week maintenance phase. Participants will wear Fitbit trackers daily and engage in goal-setting, peer discussions, and physical activity reminders. Researchers will measure moderate to vigorous physical activity, sedentary time, and health-related quality of life over 12 weeks. Additional evaluations include physiological markers of heart and metabolic health and qualitative interviews to improve the program. The study lasts through the intervention phases with ongoing monitoring and support for participants.

Researchers are studying how blood cell growth patterns called therapy-related clonal hematopoiesis t-CH relate to heart health and cardiovascular disease CVD in patients who had Hodgkin lymphoma as children or young adults. The study aims to find out how common t-CH with mutations linked to CVD is in patients treated with certain chemotherapy drugs anthracyclines and to compare heart health between those with and without these blood cell changes using cardiac MRI. They also want to see if factors like radiation, age, sex, or other treatments affect the presence of t-CH and heart disease signs. This is an observational study where participants provide blood samples, complete surveys, and have cardiac MRI scans. Researchers also review medical records and may collect archived blood samples if available. The study focuses on patients who were treated for classical Hodgkin lymphoma with anthracyclines and finished treatment at least two years before joining the study. Participants will be involved in blood collection, surveys, MRI scans, and medical record reviews to assess heart health and blood cell growth patterns. Researchers will measure the presence and expansion of t-CH mutations related to cardiovascular disease over up to one year. The study helps identify who may be at risk for heart problems after cancer treatment so doctors can monitor them more closely. The study is set to complete by October 2028.

Researchers are comparing two chemotherapy treatment plans for patients with newly diagnosed intermediate-risk rhabdomyosarcoma, a type of soft tissue cancer. This phase III trial evaluates whether a higher dose chemotherapy over a shorter time Regimen A is better than a lower dose chemotherapy followed by maintenance treatment over a longer time Regimen B, both combined with standard surgery and radiation. The study also aims to assess survival rates, treatment side effects, and molecular features of the tumor. Participants are randomly assigned to one of two treatment groups. Regimen A involves multiple cycles of vincristine, dactinomycin, and cyclophosphamide given intravenously every 21 days, with possible surgery during week 12 and radiation treatments during specified cycles. Regimen B includes alternating cycles of vincristine, dactinomycin, cyclophosphamide, and irinotecan, followed by 24 weeks of maintenance chemotherapy with vinorelbine and oral cyclophosphamide. Both groups undergo imaging scans and biopsies as needed during treatment. Throughout the study, participants will have regular CT or MRI scans and blood tests, along with other procedures such as lymph node biopsies, bone marrow tests, and lumbar punctures to monitor disease status. After treatment, follow-up visits occur every 3 months for the first year, then less frequently up to 5 years to check for event-free survival and overall health. The trial also collects biospecimens for future research and evaluates treatment effects on fertility and quality of life.

This research aims to evaluate the effectiveness and safety of risdiplam in children under 2 years of age with spinal muscular atrophy SMA who have two SMN2 gene copies and have previously received gene therapy with onasemnogene abeparvovec but now show a plateau or decline in their function. The study focuses on pediatric participants diagnosed genetically with SMA and experiencing these specific issues after gene therapy. Participants will receive risdiplam orally once daily for a treatment period of 72 weeks, with the dose adjusted according to weight and age. Following this treatment period, there will be a 1-year extension phase, making the total study duration approximately 120 weeks about 2.5 years for each participant. During the study, participants will be regularly assessed, including measuring changes from baseline in motor development using the Bayley Scales of Infant and Toddler Development at 72 weeks. Researchers will monitor adverse events and treatment discontinuation throughout the entire 120 weeks. The study involves close safety monitoring and evaluation of motor function changes, with ongoing assessments during both the treatment and extension periods.

Researchers are investigating the best way to combine chemotherapy and radiation therapy for patients aged 3 to 29 years with localized non-germinomatous germ cell tumors NGGCT in the brain. This phase II trial aims to optimize treatment based on how well the tumor responds to initial chemotherapy, with the goal of reducing spinal cord relapses and adjusting therapy for better disease control. The study also compares different radiation types and examines cognitive and physical effects in children and young adults with NGGCT. Participants first receive induction chemotherapy consisting of carboplatin, etoposide, and ifosfamide over six cycles every 21 days. Based on tumor response, patients are assigned to one of two plans Plan A involves whole ventricular plus spinal canal irradiation WVSCI, delivered daily for 6 weeks, while Plan B includes high-dose chemotherapy with stem cell transplant followed by radiation therapy to the whole brain and spine. Some patients may undergo second-look surgery depending on tumor response before continuing treatment. Throughout the study, participants undergo MRI scans, collection of cerebrospinal fluid and blood samples, and questionnaires assessing cognitive, social, and behavioral functioning. Researchers monitor tumor response, progression-free survival, overall survival, and patterns of disease recurrence for up to 10 years. Safety and side effects are also evaluated to better understand long-term outcomes of these treatment approaches.

Researchers are evaluating how well combination chemotherapy works in treating patients with newly diagnosed stages 2 to 4 diffuse anaplastic Wilms tumor DAWT and patients with relapsed favorable histology Wilms tumor FHWT. This phase II trial compares the effects of two chemotherapy regimens, UH-3 and ICECycloTopo, on event-free survival and overall survival, aiming to improve outcomes based on different relapse risk groups and prior treatments. The study also explores kidney toxicity, genetic markers, surgery impacts, and radiation therapy techniques to reduce side effects and better understand tumor behavior. Participants are assigned to one of two treatment groups. In Arm I Regimen UH-3, patients receive cycles of vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan intravenously over various days in a 21-day cycle, with radiation therapy at week 7 of cycle 3 if needed. In Arm II Regimen ICECycloTopo, patients receive cycles of carboplatin, etoposide, ifosfamide, cyclophosphamide, and topotecan intravenously over 10 cycles every 21 days, with surgery andor radiation therapy during certain cycles as clinically indicated. Throughout the trial, patients undergo multiple imaging tests including CT scans, PET scans, chest x-rays, MRIs, abdominal ultrasounds, and bone scans, along with blood sample collections and biopsies. After completing treatment, follow-up visits occur every 3 months for the first 2 years, then every 6 months for years 3 and 4, and once at year 5. The main outcomes measured are event-free survival and overall survival up to 5 years from study entry, with ongoing monitoring for treatment effects and safety.

Researchers are evaluating treatments for children and young adults with low-risk and average-risk medulloblastoma, a type of brain cancer. This phase III trial aims to reduce hearing loss caused by cisplatin chemotherapy in average-risk patients by adding sodium thiosulfate STS to standard treatment. For low-risk patients, the study tests whether reduced radiation therapy can maintain benefits while causing fewer side effects. The study also monitors survival, tumor recurrence, and quality of life outcomes. Participants receive radiation therapy five days a week for six weeks, alongside weekly vincristine infusions during this period. Following chemoradiotherapy, maintenance therapy includes cycles of lomustine, cisplatin, sodium thiosulfate, cyclophosphamide, and vincristine given on specific days over up to nine cycles, depending on tolerance and disease progression. Patients undergo regular MRI scans and may provide cerebrospinal fluid and blood samples during the study. Throughout the trial, participants are closely monitored with hearing tests, neurocognitive assessments, and quality-of-life surveys. Follow-up visits occur every three months for the first two years, every six months for years three and four, and annually up to ten years to track hearing loss, event-free survival, overall survival, tumor recurrence, and psychosocial outcomes. The study also collects biological samples for future molecular research, with the total participation lasting up to ten years.

This trial studies children, adolescents, and young adults with Philadelphia chromosome positive Ph or ABL-class Philadelphia chromosome-like Ph-like B-cell acute lymphoblastic leukemia B-ALL. It evaluates the combination of blinatumomab with dasatinib or imatinib alongside standard chemotherapy. The study aims to estimate 3-year event-free survival and overall survival, describe safety and toxicity, and explore treatment responses and immune function in these patients. Participants receive a modified chemotherapy regimen including multiple cycles of blinatumomab without traditional consolidation chemotherapy combined with continuous tyrosine kinase inhibitors dasatinib or imatinib depending on fusion subtype. Treatment includes induction phases, blinatumomab blocks, interim maintenance, delayed intensification, and maintenance cycles over two years, with various drugs administered orally, intravenously, or intrathecally. Radiation therapy may be given in some cases. Throughout the study, participants undergo blood and cerebrospinal fluid sample collection, bone marrow biopsies, and heart function tests such as echocardiography or multigated acquisition scans. Researchers monitor minimal residual disease, treatment-related side effects, and long-term outcomes up to three years. The study involves regular assessments to evaluate treatment effectiveness and safety over the full duration of therapy.

Researchers are evaluating the combination of nivolumab and blinatumomab compared to blinatumomab alone in children and young adults aged 1 to under 31 years with first relapse of CD19 B-cell acute lymphoblastic leukemia B-ALL, including patients with Down syndrome. This phase II trial aims to compare event-free survival after reinduction and consolidation therapy, assess safety and tolerability, and explore various outcomes such as remission rates and toxicity, with follow-up up to 10 years after enrollment. Participants receive treatments based on their assigned groups and arms, involving cycles of immunotherapy including blinatumomab, nivolumab, dexamethasone, methotrexate, and other chemotherapy drugs given by various routes such as intravenous infusion, intrathecal injection, and oral administration. Treatment cycles repeat every 36 or 37 days for up to two cycles, with some groups receiving radiation therapy or maintenance chemotherapy afterward. Patients with high white blood cell counts or specific disease locations may receive pre-immunotherapy treatments. Throughout the study, participants undergo lumbar punctures, bone marrow biopsies and aspirations, and collection of blood, urine, and cerebrospinal fluid for monitoring. Researchers measure outcomes such as minimal residual disease negative remission rates and event-free survival. After completing treatment, participants are followed every three months for one year to monitor their health and any long-term treatment effects.