Search Results Within Category "Children's Health"
Pennsylvania Adoptees Longitudinal Study (PALS)
This study will examine various factors within the home of children adopted from the child welfare system between the ages of 4 and 10 that may impact their development. The first visit will occur remotely via Penn State Health Microsoft Teams; the second visit is optional and will occur within 4 weeks of the first visit at the Transforming Lives of Children Center in Harrisburg, PA; and the third visit will occur one year after the first visit, when research staff will travel to participants' homes. This research will help understand the factors that impact the development of children adopted from the child welfare system and how we may better serve these children and their families.
The child and parent will be asked to complete interviews, questionnaires and various tasks. Parents may also be asked to complete questionnaires online. Participation will last for one year and include the following: -One visit occurring remotely via PSH Microsoft Teams -One visit at the Transforming the Lives of Children Center in Harrisburg, PA, four weeks after Zoom visit (optional) -Final visit at home will occur one year after the first Zoom visit
$225
Child legally adopted by the caregiver
The same caregiver will participate in each of the visits
A biological parent resides in the same home as the child
Emotion Regulation and Mother-Infant Synchrony
The aim of this study is to better understand emotion regulation in infants by measuring brain, behavior, and mother-infant relational mechanisms. We plan to collect simultaneous brain activation in mothers and infants while they engage in a face-to-face interaction. We will then test associations between individual brain activation, mother-infant brain synchrony, and infant emotion regulation behaviors.
Participants complete questionnaires online, then come in for 1 in-person visit. Mother and baby complete a play and a neutral task while fNIRS is collected from them simultaneously.
40
Infants born 3 weeks within their due date.
Infants of a birth weight > 2500 g.
Infants with NO serious medical complications.
English-speaking families.
Infants who experienced any serious medical complications.
Infants who were born > 3 weeks before the indicated gestational period.
Families who do not understand and do not speak English
Predicting Concussion Outcomes with Salivary miRNA
The purpose of this study is to identify changes in salivary micro ribosomal nucleic acid (miRNA) expression that are predictive of symptom duration and severity following mild traumatic brain injury (mTBI) in children. The primary endpoints of this study are as follows: 1) Characterization of brain-related miRNA in the saliva of 250 children with mTBI and 200 age- and gender-matched controls between the ages of five and twenty-three years. 2) Identification of a set of salivary miRNAs that is predictive of duration and severity of mTBI symptoms.
Saliva collection and surveys at baseline, 7 days, and 30 Days
$20
Seen in the Penn State Pediatric Concussion Clinic within 2 weeks of most recent concussion
Periodontal disease
Ongoing seizure disorder, or other neurologic disorder
Drug or alcohol dependency
clinical diagnosis of severe TBI
Observations of Family Mealtime Routines
The purpose of this study is to gather information about what family mealtimes look like for families with children between the ages of 3 and 8. Families will be asked to video record their family mealtime, in addition to answer some questions and to complete some questionnaires, some about body image and dieting.
On one occasion, your family's mealtime will be recorded via Zoom. You and your family will be asked some questions and to complete some questionnaires online.
$20
Adults age 18 and older
Children, ages 3-8
Individuals fluent in English
Caregivers who are under the age of 18
Individuals who are not fluent in English
Families without at least one child age 3 to 8
Making Second Language Learning More Inclusive in the Elementary Classroom: A Metalinguistic and Multimodal Approach
This study aims to find out whether learning German can help children with language difficulties improve their English skills. Children will learn German grammar using colors, shapes, and simple explanations to help them understand how language works.
Participants will complete 20 one-hour Zoom sessions over 10 weeks. During these sessions, they will learn German using a visual and interactive approach that highlights both similarities and differences between German and English. Some sessions will involve fun learning activities, while others will include assessments of language, cognitive, and metalinguistic skills.
$300
Aged 7-11
Have English as their first language
Have significant difficulties understanding and/or expressing themselves in English
Are suspected of having another neurodevelopmental disorder, based on parent report or observed behavior
Have a hearing impairment
Monitoring Eating Across Locations (MEAL) – Timing, Intake, and Mealtime Evaluation (TIME)
We know that both what (e.g., apples, pizza) and how (e.g., large vs small bites, fast vs slow) can contribute to overeating. The study will be focused on how children eat. We want to see if children eat the same way in the lab as they eat at home. We will assess laboratory and home eating styles (e.g., bite rate) in 100 prepubertal 6-9-year-old children. Children will be video-recorded while consuming identical study-provided meals at home and in the laboratory in addition to a ‘typical’ meal at home.
Healthy 6-9 year-olds and their parents are needed for the MEAL-TIME Study at Penn State University. We are looking for children to help us learn about how kids respond to different types of foods and computer games. The study consists of 3 visits to our facilities in Noll and Chandlee Labs, located on the University Park Campus. Your child will eat a meal and complete computer game tasks at each visit. Between visits, you will be asked to record your child eating at home using a study-provided smart phone. Your child will also complete an IQ test. Some children may experience anxiety when completing clinical procedures (e.g., height, weight). You and your child will be compensated $50 per visit for a total of $150. Each visit is expected to be 1.5 hours long and at-home meal recordings are expected to take 30-45 min, for a total of 8 hours participating in our lab.
$150
children are of good health with no learning disabilities (e.g., ADHD, determined by parent report)
children are not on any medications known to impact body weight, taste, food intake, behavior, or blood flow
parents report that children like and are willing to eat study foods
children are not color blind
If they don’t speak English
If they have a learning disability, ADD/ADHD, language delays, autism or other neurological or psychological conditions
If they have a pre-existing medical condition such as type I or type II diabetes, rheumatoid arthritis, Cushing’s syndrome, Down’s syndrome, severe lactose intolerance, Prader-Willi syndrome, HIV, cancer, renal failure, or cerebral palsy
AHOD2131: A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma
AHOD2131:A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab. This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma.
Consent to treatment, required labs and imaging, sample collections, and completion of research study tests and surveys and/or questionnaires.
Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified (NOS)) with Stage I or II disease
Patients must have bidimensionally measurable disease (at least one lesion with longest diameter ≥ 1.5 cm)
Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI allowed if intravenous contrast enhanced CT is also obtained.
Pediatric patients (age 5-17 years) with known or suspected mediastinal disease must have an upright PA CXR for assessment of bulky mediastinal disease.
Patients with a history of active interstitial pneumonitis or interstitial lung disease
Patients with a diagnosis of inherited or acquired immunodeficiency that is poorly controlled or requiring active medications, such as primary immunodeficiency syndromes or organ transplant recipients
Patients with peripheral neuropathy > Grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome.
Administration of prior chemotherapy, radiation, or antibody-based treatment for cHL
AAML1831: A study to compare standard chemotherapy to therapy with CPX-351 and/or gilteritinib for patients with newly diagnosed AML with or without FLT3 mutations
This phase III trial compares standard chemotherapy to therapy with CPX-351 and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.
Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.
Patient must be newly diagnosed with de novo AML according to the 2016 WHO classification152 with or without extramedullary disease.
All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831.
Patients with persistent cardiac dysfunction prior to enrollment
Pregnancy and Breastfeeding
ACNS1833-A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
This phase 3 trial compares the effect of selumetinib versus the standard of care treatment with carboplatin and vincristine (CV) in treating patients with newly diagnosed or previously untreated low-grade glioma (LGG) that does not have a genetic abnormality called BRAFV600E mutation and is not associated with systemic neurofibromatosis type 1. Selumetinib works by blocking some of the enzymes needed for cell growth and may kill tumor cells. Carboplatin and vincristine are chemotherapy drugs that work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. The overall goal of this study is to see if selumetinib works just as well as the standard treatment of CV for patients with LGG. Another goal of this study is to compare the effects of selumetinib versus CV in subjects with LGG to find out which is better. Additionally, this trial will also examine if treatment with selumetinib improves the quality of life for subjects who take it.
Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.
Patients must have a body surface area (BSA) of ≥ 0.5 m2 at enrollment.
Non-neurofibromatosis type 1 low-grade glioma without a BRAFV600E mutation confirmed by Central Pathology and Molecular Screening Reviews performed on APEC14B1, CCDI-MCI, or accepted CLIA-certified test.
Adequate renal, liver, cardiac, and bone marrow function
Patients with a known seizure disorder must be stable and must not have experienced a significant increase in seizure frequency within 2 weeks prior to enrollment
Patients with a concurrent malignancy or history of treatment (other than surgery) for another tumor within the last year are ineligible
Patients with diffuse intrinsic pontine tumors as seen on MRI (> 2/3 of pons involvement on imaging) are not eligible even if biopsy reveals Grade I/II histology
Patients may not be receiving any other investigational agents
Patients with any serious medical or psychiatric illness/condition, including substance use disorders or ophthalmological conditions, likely in the judgment of the investigator to interfere or limit compliance with study requirements/treatment
A Phase 2 Study Using Chemoimmunotherapy with Gemcitabine, Cisplatin and Nivolumab in Newly Diagnosed Nasopharyngeal Carcinoma (NPC)
To evaluate safety of combining chemotherapy (cisplatin and gemcitabine) with an anti-PD1 immune checkpoint inhibitor (nivolumab) in children, adolescents and young adults with nasopharyngeal carcinoma (NPC) by determining the rate of CTCAE Grade 3 or higher immune related adverse events (irAEs).
Consent to treatment, required labs, imaging, and sample collections.
Newly diagnosed AJCC Stage II-IV nasopharyngeal carcinoma (NPC)
Patients must have a Lansky (for patients ≤ 16 years of age) or Karnofsky (for patients > 16 years of age) performance status score of ≥ 60%.
Patients who received prior chemotherapy or radiation for the treatment of any cancer in the last 3 years. These patients must also be in remission
Patients with a diagnosis of immunodeficiency
Patients with a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
Patients who have undergone solid organ or allogeneic hematopoietic transplant at any time.
Pediatric Acute Leukemia (PedAL) Screening Trial – Developing New Therapies for Relapsed Leukemias
Primary Aims: 1. To utilize clinical and biological characteristics of acute leukemias to screen for patient eligibility for available Phase I/II PedAL sub-trials. 2. To maintain a longitudinal and comprehensive registry from relapse in children and young adults with recurrent and refractory leukemia.
Consent to enrollment, required labs and sample collections.
Patient has known or suspected relapsed/refractory (including primary refractory) AML-This includes isolated myeloid sarcoma.
Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome (ML-DS)
Patient has known or suspected relapsed ALL
Patient has known or suspected relapsed/refractory (including primary refractory) mixed phenotype acute leukemia (MPAL)
COG APEC14B1 - Project: Every Child for Younger Patients With Cancer
The next generation of therapy for childhood cancers will be based upon in-depth molecular phenotyping that may facilitate the development of rational risk-adapted and target-based therapies. In order to support current and future molecularly-guided therapeutic trials and the basic science discovery efforts that will lead to more effective therapies, prevention, early detection and a reduction in early and late-onset toxicities, it is critical to implement universal, high-quality collection of annotated biospecimens from children with cancer. This protocol provides for the collection of biospecimens and accompanying demographic, epidemiologic, therapeutic, and outcome data from all children diagnosed with cancer at participating COG institutions, independent of the patient’s enrollment on a therapeutic clinical trial. Through this approach, the correlation of phenotypic and genotypic or other –omic data with the relevant outcomes at the individual, disease, and protocol levels will be ensured. Biospecimen requirements and handling may be disease specific and thus a detailed manual of procedures will provide disease specific information regarding sample collection and processing based on the clinical diagnosis.
Consent to enrollment, eligibility screening and sample collections.
Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations
Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem.
All cancer cases with an ICD-O histologic behavior code of one “1” (borderline), two “2” (carcinoma in situ) or three “3” (malignant).
All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant
ACNS2021 - A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular &Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor
This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT.
Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.
Patients must be newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology
and/or serum or CSF elevation of AFP above institutional normal or > 10 ng/mL or hCGβ > 100 mIU/mL as confirmed by Rapid Central Marker Screening Review on APEC14B1-CNS.
Disease/Staging Imaging
CSF Cytology and tumor markers
Patients with only mature teratoma and non-elevated markers upon tumor sampling at diagnosis
Patients who have received any prior tumor-directed therapy for their diagnosis of NGGCT other than surgical intervention and corticosteroids
Patients with metastatic disease (i.e., MRI evaluation, lumbar CSF cytology or intraoperative evidence of dissemination)
Pregnancy and Breastfeeding
ACCL1931: A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy
The study involves taking the drug levocarnitine during standard of care chemotherapy. The overall goal of this study is to determine whether taking levocarnitine will reduce the rate of severe liver damage caused by asparaginase chemotherapy during the first month of treatment.
Consent to treatment, required labs, sample collections, and completion of surveys.
Diagnosis: Newly Diagnosed B-ALL, T-ALL, Lymphoblastic Lymphoma (LLy), or Mixed-Phenotype Acute Leukemia/Lymphoma (MPAL) Note: PH+ and PH-like acute leukemia are eligible (use of TKI or CRLF2-targeted concomitant medication must be documented, if used)
Adequate liver function
Adequate renal function
Known inherited or autoimmune liver disease impacting conjugated bilirubin (e.g., Alagille Syndrome, primary sclerosing cholangitis, other)
Known biopsy (or imaging) proven severe liver fibrosis (Batts-Ludwig ≥ Stage 3)
Unable to tolerate oral formulation of study drug at enrollment
Patients who received chemotherapy or treatment for a prior malignancy are not eligible
AREN1921:Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)
This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out what effects, good and/or bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE/Cyclo/Topo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).
Consent to treatment, required labs, sample collections, and imaging.
Enrollment on APEC14B1
Newly diagnosed Stages 2 - 4 diffuse anaplastic Wilms tumor as confirmed by central review
Favorable histology Wilms tumor at first relapse. Relapsed FHWT patients must have previously achieved remission for their initial FHWT diagnosis to be eligible for this study
Patients must have a performance status corresponding to ECOG scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age.
Patients with any uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, or symptomatic congestive heart failure
Relapsed FHWT patients who did not receive frontline chemotherapy (e.g., very low risk FHWT initially observed without chemotherapy) or received only one chemotherapy agent for frontline therapy
Patients with Renal Tubular Acidosis (RTA) as evidenced by serum bicarbonate < 16 mmol/L and serum phosphate ≤ 2 mg/dL (or < 0.8 mmol/L) without supplementation
Umbrella Long Term Follow Up Protocol (COG ALTE05N1)
Umbrella Long Term Follow Up Protocol (COG ALTE05N1)
Consent to enrollment and eligibility screening and completion of surveys and/or questionnaires.
or The patient must have been enrolled on a COG (or Legacy Group) therapeutic or non-therapeutic trial targeted for long-term follow-up by ALTE05N1
The patient must reside in the U.S. on the date of enrollment to ALTE05N1
COG AALL1621 - Inotuzumab Ozogamicin in Treating Younger Patients With Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia
This Phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with CD22 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotoxins, such as inotuzumab ozogamicin, are antibodies linked to a toxic substance and may help find cancer cells that express CD22 and kill them without harming normal cells.
Consent to treatment, required labs, sample collections, and completion of research study tests.
Patients must have B-ALL, or previously diagnosed B-LL, with ≥ 5% (M2 or M3) bone marrow blasts with or without extramedullary disease.
Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age
Patients with isolated CNS, testicular, or any other extramedullary site of relapse.
Patients who have been previously treated with inotuzumab ozogamicin.
History of allergic reaction attributed to compounds of similar or biologic composition to inotuzumab ozogamicin or other agents in the study.
Patients with active optic nerve and/or retinal involvement are not eligible. Patients who are presenting with visual disturbances should have an ophthalmologic exam and, if indicated, an MRI to assess optic nerve or retinal involvement.
ANBL1531 Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
This phase III trial studies iobenguane I-131 or lorlatinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or lorlatinib and standard therapy may work better compared to lorlatinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.
Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.
Patient must be ≥ 365 days and ≤ 30 years of age at diagnosis
Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites.
Patients who have an INRG Stage L2 tumor without amplification of MYCN regardless of tumor histology (may meet criteria for may meet criteria for high risk classification but are not eligible for this trial).
Patients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disorders.
AOST2031: A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma
The overall goal of this study is to compare the effects, good and/or bad, of two different surgery methods for people with OST that has spread to the lung to find out which is better. In this study, participants will receive 1 of 2 treatment plans. Treatment with open surgery is the older standard therapy for people with OST that has spread to the lung. Treatment with VATS is a newer method that has also been shown to work when used to treat the same type of cancer
Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.
Patients must have ≤ 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being ≥ 3 mm and all of which must be ≤ 3 cm size
Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon
Patients must have a histological diagnosis of osteosarcoma
Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.
Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.
Patients with evidence of extrapulmonary metastatic disease
Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment
Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. N
ANBL1821 - A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab with or without Eflornithine (DFMO) (IND# 141913) in Children with Relapsed, Refractory, or Progressive Neuroblastoma
This phase II trial studies how well irinotecan hydrochloride (irinotecan), temozolomide, and dinutuximab work with or without eflornithine in treating patients with neuroblastoma that has come back or that isn't responding to treatment. Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as dinutuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Eflornithine blocks the production of chemicals called polyamines that are important in the growth of cancer cells. Giving eflornithine with irinotecan hydrochloride, temozolomide, and dinutuximab, may work better in treating patients with relapsed or refractory neuroblastoma.
Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.
Patients must have had histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary catecholamines, at the time of initial diagnosis
Patients must have a performance status corresponding to ECOG scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients 16 years of age.
Patients must not have received prior treatment with irinotecan and temozolomide.
Patients must not have been diagnosed with myelodysplastic syndrome or with any malignancy other than neuroblastoma
Patients with symptoms of congestive heart failure are not eligible.
Patients must not have uncontrolled infection.
AALL1732 Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy
This phase III trial studies how well inotuzumab ozogamicin and post-induction chemotherapy work in treating patients with high-risk B-cell lymphoblastic lymphoma (B-ALL), mixed phenotype acute leukemia, and B-lymphoblastic lymphoma (B-LLy). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, cytarabine, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, thioguanine, vincristine, and pegaspargase, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The goal of the part 1 of the study is to collect information about leukemia and the effects of the first two phases of treatment, called Induction and Consolidation on this cancer. Additionally, this study aims to investigate whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for 3 years from the start of Interim Maintenance in patient with High Risk Favorable (HR-Fav) and HR B-ALL. Another aim is to understand the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) receiving HR B-ALL therapy. Finally, another goal of this study is to determine the outcomes of subjects with Mixed Phenotype Acute Leukemia (MPAL) with a favorable early response to treatment using High Risk B-cell Acute Lymphoblastic Leukemia therapy.
Consent to treatment, required labs, sample collections, and imaging.
B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to Eligibility studies (Part A) prior to treatment and enrollment on AALL1732.
White Blood Cell Count (WBC) Criteria
Patient has newly diagnosed B-ALL or MPAL (by WHO2016 criteria) with ≥25% blasts on a bone marrow (BM) aspirate
A complete blood count (CBC) documenting the presence of at least 1,000/µL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed
Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy.
Patients with Acute Undifferentiated Leukemia (AUL) are not eligible
Patients requiring radiation at diagnosis.
AHEP1531 - Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)
This partially randomized phase II/III trial studies how well cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or liver cancer after surgery. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy after surgery may kill more tumor cells.
Consent to treatment, required labs, sample collections, and completion of research study tests.
Patients in Group F must have a BSA ≥ 0.6 m2 .
Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age.
Patients newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma
Patients who are currently receiving another investigational drug
Patients who are currently receiving other anticancer agents
Patients with uncontrolled infection.
Patients who previously received a solid organ transplant, other than those who previously received an orthotopic liver transplantation (OLT) as primary treatment of their hepatocellular carcinoma.
AGCT1531 - A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplaitin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors
This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.
Standard Risk 1 Patients must be < 11 years of age at enrollmen
Standard Risk 2 Patients must be ≥ 11 and < 25 years of age at enrollment
Patients enrolling on one of the Low Risk arms must be newly diagnosed with a Stage I germ cell tumor. For the Standard Risk arms, patients must be newly diagnosed with metastatic germ cell tumor (Stage II or higher).
Patients must have a performance status corresponding to ECOG scores of 0, 1, 2 or 3. Use Karnofsky for patients > 16 years of age and Lansky for patients 16 years of age
Pure dysgerminoma
Pure mature teratoma
ARST2032: A Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-risk and Low-risk Fusion Negative Rhabdomyosarcoma
This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. To determine the feasibility of adding cabozantinib S-malate (cabozantinib) to standard MAP (high dose methotrexate, doxorubicin hydrochloride [doxorubicin], and cisplatin) chemotherapy in patients with newly diagnosed metastatic osteosarcoma with a resectable primary tumor.
Consent to treatment, required labs, sample collections, and imaging.
Patients must be ≤ 21 years at the time of enrollment
Patients must have newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma (ARMS) (institutional FOXO1 fusion results are acceptable).
Patients who have received chemotherapy or radiation for non-malignant conditions (e.g., autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy
Vincristine is sensitive substrate of the CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7 days prior to study enrollment
Patients unable to undergo radiation therapy, if necessary, as specified in the protocol
Evidence of uncontrolled infection
AGCT1532 - A Randomized Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-risk Metastatic Germ Cell Tumors
Germ Cell Tumors (GCTs) are sorted in “risk groups” that describe how much the tumor has grown in the body. The three “risk groups” are: good, intermediate, and poor. For this study, we are interested in learning more about intermediate and poor-risk GCTs, also known as “advanced” GCTs. A research study is when doctors work together to try out new ways to help people who are sick. In this study, we are trying to learn more about how to treat GCTs. Standard treatment for advanced GCTs is chemotherapy (anti-cancer drugs). Some of the drugs used may cause bad effects that show up during treatment. This study will compare the standard way to treat GCTs with the same type of treatment, but delivered over a shorter amount of time (called “accelerated” treatment). This will help us understand if the accelerated treatment is better but not more harmful than the standard treatment. We will do this by closely watching to see if the cancer grows or spreads. We do not know which treatment will be better, which is why we are doing this study.
Consent to treatment, required labs, sample collections.
Histologically or cytologically confirmed germ cell tumor OR exceptionally raised tumor markers without histologic or cytologic confirmation
Primary arising in testis, ovary, retro-peritoneum, or mediastinum
Metastatic disease or non-testicular primary.
Significant co-morbid respiratory disease that contraindicates the use of bleomycin.
Peripheral neuropathy ≥ Grade 2 or clinically significant sensorineural hearing loss or tinnitus
Known allergy or hypersensitivity to any of the study drugs.
AOST2032: A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma
This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. In Part 1 of the study, we will find out the highest dose of cabozantinib that can be given in combination with MAP without causing side effects that are too severe. In Part 2, subjects will either receive a combination treatment of MAP with cabozantinib or MAP alone
At the start of the study and during treatment, patients will have blood drawn to check the levels of hormones from their thyroid and proteins that are made by the pancreas. Patients will also have the protein levels checked in their urine. The protein levels in the urine will be checked. In addition, patients' blood pressure will be monitored more often than usual because they are taking cabozantinib on this study.
Patients must have a body surface area of > 0.8 m 2 at the time of enrollment
Patients must have histologic diagnosis (by institutional pathologist) of newly diagnosed high grade osteosarcoma
Patients who have central nervous system metastases.
Patients with central cavitating pulmonary lesions invading or encasing any major blood vessels in the lung.
Patients who are unable to swallow tablets. Tablets cannot be crushed or chewed.
AREN2231: Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT)
The purpose of this study is to improve the treatment of children and young adults with all stages of FHWT, so that more patients are cured without relapse, and that side effects from treatment are lessened without decreasing cure rates. This study will use information on higher or lower risk features of FHWT to adjust the treatment of each subject based on their risk of relapse.
All patients will receive chemotherapy (regardless of stratum assignment) starting with 1 cycle (3 weeks) of VA (vinCRIStine, DACTINomycin) chemotherapy. Some patients will have changes in treatment based on information learned after enrollment. For all patients, at least one callback is required to be completed prior to randomization and/or prior to any change in treatment or continuation of the same treatment.
Patients must have newly diagnosed Stage I-IV Favorable Histology Wilms Tumor
Patients who in the opinion of the investigator are not able to comply with the study procedures are not eligible
Patients with any uncontrolled, intercurrent illness including but not limited to symptomatic congestive heart failure
Patients with known Charcot-Marie-Tooth syndrome
Patients receiving concurrent chemotherapy for a different diagnosis.
Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents
The overarching goal of this research is to adapt, optimize, and pilot a transdiagnostic sleep and circadian intervention so that its contents and delivery are effective and sustainable for autistic adolescents
Participants will complete assessments at two time points and engage in a 6 week behavioral sleep intervention with a trained clinician.
$75.00
Sleep problems
Ages 13-17 yrs
English speaking
A history of psychotic, bipolar or seizure disorders
Untreated sleep apnea, a history of narcolepsy, or restless legs syndrome
Usability of a Virtual Reality Laboratory for Sensory Integration
This is a usability study that will evaluate how allied health, education and technology professionals perceive a new virtual therapy environment designed for children with autism spectrum disorder. Participants will experience a guided session using a virtual reality headset. Some participants will experience the VR session with an additional wearable vest that provides gentle vibration feedback, while others will use the VR system without the vest. Assignment to these conditions will be random. After the VR session, participants will complete questionnaires about usability, immersion, and any discomfort. The goal is to improve the tool before it is used in clinical settings.
There will be only one on-site meeting with one hour of duration. Participants will take part in an 25 minutes immersive experience in a virtual environment (with or without a wearable vibration vest, depending on random assignment); and complete one questionnaire before, and four questionnaires after the experience.
$30 Amazon gift card
college degree in one of the following fields: Health, Education, AND/OR Technology
basic knowledge about Autism Spectrum Disorder (ASD), including familiarity with the diagnosis and the ability to identify some common symptoms or characteristics
neurological or vestibular conditions that may be aggravated by immersive virtual reality
pregnancy
experience of nausea, dizziness, or vomiting on the day of the study session
A Pilot Randomized Trial of a Mother-Child Dyadic Positive Affect Prevention Program for Reducing Mental Health Symptoms in Youth Exposed to Deprivation
The purpose of this voluntary research study is to test the effectiveness of the Positive Affect Intervention Program in reducing mental health symptoms for families experiencing financial hardship.
In this study, you and your child will attend some virtual and in-person study visits over 8 months. You will complete some interviews and questionnaires virtually. You will be randomly assigned to either an 8-session prevention program or to receive weekly educational materials to read. You and your child will come to the lab for in-person visits both pre and post program. During these visits, your child will complete some EEG tasks, and you and your child will complete some interaction tasks where your respiratory and heart rate data will be collected. You and your child will also be asked to complete some short daily phone surveys at home.
480 dollars
Child and biological mother can read and speak in English.
Child and mother have access to a computer or tablet with a video camera and internet that can be used for study appointments by Zoom.
Family is experiencing financial hardship.
Children or mothers with intellectual disabilities.
Children or mothers with a diagnosis of mania or bipolar disorder
Children or mothers with a diagnosis of a psychotic disorder (e.g., schizophrenia); or with visual or hearing impairments that interfere with completing study measures and sessions.
Children currently taking psychotropic medications for at least two weeks prior to study participation (except use of stimulant medication which has to be discontinued for 36-hours prior to the EEG visit).