Clinical Research Directory

Central Venous Catheter Care Training for Pediatric Oncology Nurses

The knowledge level of nurses regarding care techniques plays a crucial role in the prevention of central venous catheter-related infections. This study was designed to evaluate the effect of training on central venous catheter care (CVCC), provided to nurses caring for pediatric oncology patients, on their knowledge level and infection prevention behaviors. The study aims to determine the effectiveness of an educational program intended to enhance nurses' knowledge and practical skills in preventing CVC-related infections, thereby contributing to evidence-based practices that improve patient safety.

Vomiting Prevention in Children With Cancer

The goal of this single arm trial is to learn if a machine learning (ML) model predicting the risk of vomiting within the next 96 hours will impact vomiting outcomes in inpatient cancer pediatric patients. The main questions it aims to answer are whether an ML model predicting the risk of vomiting within the next 96 hours will: Primary 1\. Reduce the proportion with any vomiting within the 96-hour window Secondary 1. Reduce the number of vomiting episodes 2. Increase the proportion receiving care pathway-consistent care 3. Impact on number of administrations and costs of antiemetic medications Newly admitted participants will have a ML model predict the risk of vomiting within the next 96 hours according to their medical admission information. The prediction will be made at 8:30 AM following admission. Pharmacists will be charged with bringing information about patients' vomiting risk to the attention of the medical team and implementing interventions.

Generating Novel Translational and Therapeutic Strategies Based on a Multicenter, Pediatric and AYA Evolutionary Tumor Board (pedsETB)

To evaluate the ability of a multidisciplinary and multisite group, the Pediatric Evolutionary Tumor Board (pedsETB), to develop additional therapeutic strategies in patients without curative options or with suboptimal outcomes.

Ovarian Tissue Cryopreservation in Post Pubertal (OTC-Post Pubertal)

The purpose of this study is to safely remove ovarian tissue in pediatric patients, who are at risk for infertility from their medical treatment, for freezing for future restoration of fertility and hormone function.

Lurbinectedin in FET-Fused Tumors

The purpose of this study is to find out if a drug called lurbinectedin (the "study drug") is safe and effective at treating people with recurrent or relapsed solid tumors, including Ewing sarcoma.

Psychological Benefits of a Normalized Camping Experience for Children With Cancer

Background: * Cancer has an enormous impact on the psychological and social well-being of the family unit. The life-threatening connotations of cancer single out the ill child from his peer/family group as one who is different, and often unable to maintain a normal lifestyle. Physical sequelae of cancer and its treatment accentuate the differences between these children and their normal peers/siblings. * It is important that children with cancer be prepared to function outside of protected situations and begin to develop skills of separation and independence. For healthy children, some of these latter skills are acquired by a camping experience. Such an experience for the patient with cancer is frequently precluded by their dependence on medical facilities and the physical limitations of their activities. * The goal of this study will be to assess the short and long term benefits of the "normalized" camping experience, provided in conjunction with Special Love, Inc., on the patients and staff. In particular, we will seek to determine whether such a comprehensive experience is capable of influencing the attitudes and life experiences of patients and staff in a positive manner. Objectives: -To evaluate the impact of an enriched normalized camping experience on the quality of life of the pediatric cancer patient. In particular, attempts will be made to measure the manner in which this experience influences the child's sense of well-being and self-esteem as well as his or her relationship with parents, family, and peers. Eligibility: * Children 7-17 years of age who are currently being treated for cancer or are up to 3 years post therapy OR Young adults with cancer (YACers) 18-25 years of age who are acting as counselors at Camp Fantastic * All children/young adults will be selected for camp after careful screening by a multidisciplinary committee consisting of medical and program directors. * At the discretion of the multidisciplinary committee consisting of medical and program directors, special exceptions may be made for children with extenuating circumstances. Design: * Assessment of benefit may include interviews with children and families before, during and following camp. Observational data on the child's performance at camp will be noted. * Medical and nursing personnel will consist of staff from the Pediatric Branch at the NCI, other units within the NIH, and participating institutions. * Special Love members, the Program Director at the 4-H Center camp (site of the camp) and Pediatric Branch staff at the NCI will coordinate the camp program, taking into account the medical needs of each camper. * Every attempt will be made to provide a full agenda of age appropriate activities for the patients. * The length of the camping experience for children with cancer will be for 7 days beginning on a Sunday and extending through the following Saturday morning. Patients will be transported to the camp from the NIH Clinical Center and the Virginia hospitals by bus.

Medically Tailored Meals for Kids

The purpose of this project is to learn whether an intervention that provides households with home-delivered healthy, frozen meals tailored to illness related conditions for 12 weeks during a child's treatment for serious illness is feasible and acceptable to the child and parent mainly responsible for the child's care.

Cardiac Impairments Following Pediatric Cardiotoxic Anti-cancer Treatment

This study aims at investigating the feasibility of recruitment and application of a method regarding early detection of subclinical changes in cardiac health after completion of acute cancer treatment during childhood and adolescence.

Study of Zanzalintinib in Children and Adolescents With Relapsed or Refractory Solid Tumors

The primary purpose of this study is to determine the pediatric maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), and to evaluate the safety and tolerability of zanzalintinib.

A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia

The goal of this clinical trial is to learn if sonrotoclax (BGB-11417) is safe and may help treat children and adolescents with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that has come back after treatment or has not responded to treatment. The study will also learn how the body processes sonrotoclax when it is given with other medicines. The main questions it aims to answer are: * Is sonrotoclax safe and well tolerated when given with other anti-cancer medicines? * How does the body absorb, process, and remove sonrotoclax? * Does treatment with sonrotoclax, in combination with other medicines, help reduce or eliminate leukemia? Researchers will give sonrotoclax together with other anti-cancer medicines to participants with relapsed or refractory AML or ALL. Participants will: * Take sonrotoclax in combination with other anti-cancer medicines * Have regular clinic visits for physical exams, blood tests, heart monitoring, and other safety assessments. * Provide blood samples to measure how the body processes sonrotoclax. * Have tests to evaluate how their leukemia responds to treatment. * Continue treatment as long as it is helping and side effects remain manageable, according to the study plan.

Music Therapy for Oral Mucositis Pain in Pediatric Patients

This mixed-methods pilot study will examine the effect of music therapy on oral mucositis pain in pediatric oncology patients. Oral mucositis, characterized by painful ulcerative lesions in the mouth, is a common side effect of high-dose chemotherapy and hematopoietic stem cell or bone marrow transplantation. Despite its high prevalence and impact on quality of life, effective pain management strategies for pediatric oral mucositis remain limited and often rely heavily on medications that may cause significant side effects or provide insufficient relief. Music therapy may offer a promising non-pharmacologic adjunct for reducing pain, yet no studies to date have specifically evaluated its use for oral mucositis pain in pediatric patients.

Feasibility Usability & Acceptability Study: Symptom Reporting by Children Adolescents & Young Adults w/Cancer

The purpose of this project is to pilot test an electronically delivered symptom assessment tool Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE), completed by children/adolescents and young adults (AYAs) and caregivers and shared with their clinicians during an outpatient clinic visit, in preparation for a future test of intervention efficacy.

Clinical Benefit of Using Molecular Profiling to Determine an Individualized Treatment Plan for Patients With High Grade Glioma

This is a 2 strata pilot trial within the Pacific Pediatric Neuro-Oncology Consortium (PNOC). The study will use a new treatment approach based on each patient's tumor gene expression, whole-exome sequencing (WES), targeted panel profile (UCSF 500 gene panel), and RNA-Seq. The current study will test the efficacy of such an approach in children with High-grade gliomas HGG.

A Study of N9 Chemotherapy in Children With Neuroblastoma

The purpose of the study is to find out whether N9 is a safe and effective treatment for children with neuroblastoma. N9 includes 3 different combinations of chemotherapy drugs that are given at different times - Cyclophosphamide, topotecan, and vincristine (CTV), Ifosfamide, carboplatin, and etoposide (ICE), Cyclophosphamide, doxorubicin, and vincristine (CDV).

Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG).

This study will evaluate BCB-276, an investigational B7-H3-targeted Chimeric Antigen Receptor (CAR) T cell therapy, in children and young adults with diffuse intrinsic pontine glioma (DIPG). DIPG is a rare and aggressive brain tumor with limited treatment options. CAR T cell therapy uses a patient's own immune cells that are changed in a laboratory to recognize and attack cancer cells. The purpose of this study is to determine whether BCB-276, when given after completion of standard radiation therapy, is safe and can improve survival for patients with DIPG. To participate, individuals must be between 1 and 26 years of age when they join the study, have a diagnosis of DIPG, and enroll for treatment within 6 weeks of completing initial radiation therapy. Participants must not have received prior anti-cancer therapy beyond radiation with or without temozolomide prior to joining this study. BCB-276 is administered intraventricularly (into the fluid around the brain), which requires placement of a catheter for treatment. BCB-276 is given every 2 weeks at a research center over a period of several months (approximately 7-8 months). Participation includes travel to a study site, procedures to support treatment administration, sample collection, and ongoing monitoring for safety and effectiveness, with follow-up visits lasting up to about 2 years.

My Hospital Buddy Ida: AR-CBT for Children With Cancer

The goal of this clinical trial is to learn if an augmented reality (AR) mobile app-based cognitive behavioral therapy (CBT) program can help children aged 6 to 12 years who are being treated for cancer cope with treatment-related distress and improve their quality of life. The main questions it aims to answer are: * Does an AR-supported CBT app improve health-related quality of life compared with the same CBT content delivered on paper, and compared with usual care? * Does the AR-CBT app improve resilience, emotional and behavioral functioning, anxiety, and treatment-related symptoms such as nausea and fatigue, compared with the other two groups? Researchers will compare three groups: an AR-CBT group using a smartphone/tablet app called "My Hospital Buddy Ida," a Standard CBT group receiving the same content through a printed workbook, and a usual care control group, to see if the AR app leads to greater improvement in quality of life and related outcomes. Participants will: * Be randomly assigned to one of the three groups * Complete a 12-module, 9-session CBT and Child Life program (AR-CBT and Standard CBT groups) or continue usual hospital care (control group) * Complete questionnaires about quality of life, resilience, emotional and behavioral symptoms, anxiety, and treatment-related symptoms before and after the program (approximately 9 to 12 weeks later)

The Comparative Effectiveness Evaluation of the Impact of Digital Education

This study is being conducted to determine how best to educate caregivers about cancer and its treatment. When caregivers are well-informed, they are more confident in supporting their child through treatment, which can improve treatment adherence.

Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults

It involves collecting safety and efficacy data, under the actual conditions of use of off label and compassionate use medicines in children and adolescents approved in humans before 2007, using a validated tool (Ennov EDC) and relying on the network recognised pediatric hemato-oncology centers in Belgium and responsible for the organization of Pediatric National tumor boards which discuss each case of relapse in order to define the best therapeutic options.

Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer (RAISE)

Papillary thyroid cancer (PTC) is the most common form of differentiated thyroid cancer (DTC). The traditional first line treatment for patients with advanced DTC after surgical resection is radioactive iodine (RAI) therapy. However, less than a quarter of patients with lung metastases will achieve a complete response to RAI therapy, and this therapy carries the risk of pulmonary fibrosis and an increasingly recognized risk of secondary malignancies.

Immune Function and Response to Vaccination After Cancer Therapy in Pediatric Patients

Pediatric cancer survivors have increased infection-related morbidity and mortality. This study will evaluate immune dysfunction following cancer directed systemic therapy completion, with attention to clinical relevance and infection rate in this population compared to healthy siblings, when applicable. The investigators will also restart vaccinations at earlier time points than previously studied, at 3 months post therapy, and will assess whether boosters or revaccination schedules are superior for regaining immunity against potentially serious infections in survivors.

Pharmacogenomic Testing in Pediatric Hematology/Oncology Patients

Pharmacogenomic (PGx) testing involves analyzing variants of genes associated with drug metabolism, transport and medication targets. PGx testing uses an individual's genetic factors, such as single nucleotide polymorphisms (SNPs), to personalize therapy or dose a selection of medications. PGx testing has traditionally been used to test single genes, but there are now platforms allowing a panel of genes to be tested at once. To date there has not been a comprehensive screening of pediatric oncology patients to determine the prevalence of genetic variants that may affect anticancer therapy and supportive care medications. This study would allow us to summarize the frequency of clinically relevant gene-drug interactions and actionable genetic polymorphisms in pediatric oncology patients.

LCI-PED-NOS-EXER-001: Exercise in Pediatric Oncology Patients

The purpose of this study is to see if there are physical and emotional benefits to participating in a structured exercise regimen for those who are ages 2-25, are newly diagnosed with a blood or solid tumor cancer, and are currently undergoing or will begin cancer treatment.

Food is Medicine in Survivorship: Examining the Feasibility and Impact of a Scalable Food Delivery and Culinary Medicine Program (FoodiiS) Among Pediatric Cancer Survivors and Their Families

The goal of this research study is to learn if the FoodiiS-Kids intervention is useful to parents and guardians of pediatric cancer survivors.

Testing eSCCIP: An eHealth Psychosocial Intervention for English and Spanish Speaking Parents of Children With Cancer

It is critical to provide accessible evidence-based psychosocial support to parents and caregivers of children with cancer (PCCC) in order to mitigate individual and family-level psychosocial risks. This effectiveness trial evaluates an eHealth intervention for English- and Spanish-speaking (PCCC) with study endpoints focused on decreasing negative psychosocial sequelae (acute distress, posttraumatic stress, and anxiety) and improving coping abilities (coping self-efficacy, cognitive coping strategies). The long-term goal of this research program is to sustain and disseminate an effective, scalable, high-reach, and cost-effective intervention to provide crucial support to PCCC across the pediatric cancer trajectory.