Neoplasms

All Conditions

Rare Diseases

Neuroblastoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Hematinics

Antineoplastic Agents

Amino Acids

Morphine

Liver Extracts

3-Iodobenzylguanidine

Ceritinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

All participants with relapsed or refractory neuroblastoma will have a tumor biopsy to identify genetic mutations. There is no drug given in this arm of the trial.

Qualified participants whose tumors show certain mutations in the anaplastic lymphoma kinase (ALK) pathway (based on genetic sequencing results) will receive a combination therapy of ceritinib and ribociclib, to be administered orally in 28-day cycles.

Two different doses of ceritinib and three different doses of ribociclib will be evaluated. Once the investigators have identified the highest safe dose of both drugs that can be given at the same time, additional participants will be enrolled in the study at this dose level.

It is possible that if starting at a lower dose, participants may take a higher dose once that dose has been deemed safe.

Biopsy

Tumor tissue will be sent to Foundation Medicine laboratory for molecular profiling.

Next Generation Sequencing

Participants will undergo different types of scans to look at your tumor. These scans include CT (computerized tomography), MIBG (meta-iodobenzylguanidine) PET (positron emission tomography), and MRI (magnetic resonance imaging). Participants may have more than one type of scan.

Tumor Scans

Participants will have needles inserted through their hip bone to remove fluid from inside the bone marrow. This test determines if participants have tumor in the bone marrow.

Bone marrow Tests

The exam includes taking participant weight, height, blood pressure, heart rate and respiratory rate and performing a examination of the participants body. The investigators may also check the participants vision with an eye chart.

Physical Exam

Participants will have their eyes will be evaluated using different instruments. Participants will also be asked to read an eye chart. The exams will take about 15 minutes.

Eye Exam

Standard blood tests will be done to measure different types of blood cells, to measure the amount of certain substances, and tests to check how well liver and kidneys are working. When possible, the investigators will take blood from the participants central line. If this is not possible, the investigators will take blood from a vein in the participants arm. First, the investigators will put some cream on the skin so that drawing blood will not be painful. Then the investigators will put a thin needle into the vein to draw the blood.

Labs

If the participant is 11 years old or older or has already started having periods, the participant will be asked to take a pregnancy test before starting this study. The results will be shared with the participant but not with the participants' parent(s). We strongly encourage the participant to share the results with the parents. If the participant is found to be pregnant, the participant will not be able to continue participation in the study. About 1 teaspoon of blood (or urine if a urine test) will be needed.

Pregnancy Test

A team member will take the participant's medical history, along with a listing of any medications that are being taken. Throughout the study, participants will be asked to report if they think that anything bad has happened as a result of the study.

Interviews

This is a test of electrical activity of the heart. The investigators will put electrodes (sticky pads attached to wires) on the participant's chest, arms and legs. The electrocardiogram (ECG) will not be uncomfortable, but the participant will have to lie still. It does not hurt and takes about 15 minutes.

The participant will have an ultrasound of the heart taken to assess heart function. The investigators will put some gel on the skin and use a machine to take pictures of the heart.

Echocardiogram

Participants will take ribociclib once per day orally for Days 1-21 of a 28-day cycle.

Ribociclib

Participants will take ceritinib once per day orally for 28 days of a 28-day cycle.

Yael P Mossé, MD

John M Maris, MD

The purpose of this research study is to match genomic aberrations in tumor cells at time of relapse to rationally designed combinations of molecularly targeted agents. This study will be done in two parts:

Part I: Tumor will be accessed at study entry via a biopsy and subjected to deep sequencing to identify protocol-specified biomarkers for therapy assignment.

Part II: If the tumor contains a genetic change defined by the study as being actionable, and other criteria are met, participants will be assigned to therapy based upon the genetic changes identified in the tumor biopsy.

Next Generation Personalized Neuroblastoma Therapy

Next Generation Personalized Neuroblastoma Therapy (The NEPENTHE Trial)

The primary variable is the incidence of dose limiting toxicities (DLTs) during the first 28 days of therapy

Area under the plasma concentration time-curve from zero to the last measured concentration

To describe whether the assigned targeted therapy can mediate anti-tumor effects in subjects with relapsed or refractory high-risk neuroblastoma within the context of a phase 1/phase1b biomarker-driven trial. Percentage of patients with objective response will be according to the International Neuroblastoma Response Criteria.

Neuroblastomas undergo substantial mutational evolution during therapy, and relapsed disease is more likely to be driven by a targetable oncogenic pathway. Genomic alterations measured by next-generation sequencing at time of disease progression will be characterized and reported in a descriptive manner.

Novartis Pharmaceuticals

Foundation Medicine

Yael P Mosse

Principal Investigator

Behaviors and Mental Disorders

Quality of Life

Any CHCO patient referred for integrative interventions by the Pain Service or the Palliative Care Service.

Patients at CHCO include premature infants through young adults. Any of these patients could benefit from integrative treatments. The treatments will only be offered after medical team approval and parental consent. All treatments will be provided by credentialed and licensed providers and will follow CHCO approved policies and procedures.

Electronic self-report questionnaires before and after integrative interventions, and monthly.

Questionnaire

Physical measures before and after integrative interventions, and monthly. Thoracic kyphosis will be measured with a non-invasive gravity dependent inclinometer (Isomed Inc.).

Jennifer Raybin, PhD

Catherine Jankowski, PhD

Jennifer Raybin

As healthcare demands high-quality cost-effective care and patients seek self-management strategies, integrative medicine has become more of an interest to patients, physicians, and administrators. The NIH has a dedicated center (National Center for Complementary and Integrative Health) for integrative therapies. Additionally, these treatments must meet evidence-based criteria for efficacy to be considered for reimbursement and in order for clinical settings to integrate them into the standard of care.

The care of children at the quaternary children's hospital is focused in traditional Western medicine modalities of diagnosis, surgery, and medical treatment with pharmacologic medications. However, integrative health modalities, such as acupuncture, massage, Reiki, nutritional supplements, or oral complementary therapies (such as cannabinoids) have been increasingly discussed by our patients, especially during Palliative Care Consults. As healthcare demands high-quality cost-effective care and patients seek self-management strategies, integrative medicine has become more of an interest to patients, physicians, and administrators. The NIH has a dedicated center (National Center for Complementary and Integrative Health) for integrative therapies. Additionally, these treatments must meet evidence-based criteria for efficacy to be considered for reimbursement and in order for clinical settings to integrate them into the standard of care. The objective of this project is to examine feasibility, timing, appropriate measures, and provide the basis for future in-depth study of the outcomes of individual integrative symptom management strategies.

Hypotheses:

Children, adolescents, and young adults will be able to complete electronic self-report questionnaires and physical measures before and after integrative interventions, and monthly.

Caregivers will be able to complete electronic proxy questionnaires before and after integrative interventions, and monthly.

Integrative interventions will be associated with changes on the questionnaires and physical measures such as a decrease in frequency, severity, or level of interference with symptoms.

Participants will rate their satisfaction with integrative interventions positively.

Integrative Health Interventions in Symptom Management of Pediatric Patients

QuICK: A Quality of Life Study of Integrative and Complementary Therapies for Kids (An Exploratory Feasibility Study of Data Collection)

The team will determine which therapy will be used when administering the questionnaire

The team will identify which therapy will be used when administering the questionnaire. The type of therapy will determine the length of time.

The accrual rate based on percentage of eligible patients who are approached vs how many sign consent.

Identify patient satisfaction of integrative intervention by having the patient rate the integrative intervention

The Pediatric Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system is content valid for children ages 7 years and older The 15 core CTCAE terms are abdominal pain, constipation, diarrhea, mucositis, nausea, vomiting, fatigue, pain, anorexia, headache, peripheral sensory neuropathy, anxiety, depression, insomnia, and cough. The measure uses a 4-point Likert-type scale to assess frequency, severity, and level of interference.

Determine patient Quality of Life (QOL) using Pediatric Patient Reported Outcomes Measurement Information System (PROMIS).

Acceptable item and scale reliability have been documented. Items are scored from 0 (never) to 4 (almost always) for symptom interference and psychological measures, and from 0 (with no trouble) to 4 (not able to do) for performance measures. All domains use a 5-point Likert scale and are reported as individual domain scores.

The Faces Scale has been used for evaluating emotional responses to pain on children 3-17 years old. It is a one page form with nine faces in order of happy to upset. Numerical values are given to each face as determined by childrens' perspectives for an affective value by asking 200 children to directly scale the feelings depicted by the faces.

A satisfaction questionnaire will be included as the final question in the post-intervention tool and in the three-month follow up tool. Satisfaction with each type of intervention received will be measured by a five-point Likert scale.

Collect data on the percentage of patients who have active heart rate monitoring during the intervention to give a general of the possibility of gathering vital sign data in the future.

Thoracic kyphosis will be measured with a non-invasive gravity dependent inclinometer (Isomed Inc.). The patient will assume a relaxed standing position with feet together. The evaluator palpates the spinous processes of thoracic vertebrae (T) 1, T2, T12, and lumbar vertebrae (L)1 for inclinometer placement. First, the caudal inclinometer is placed on T12 and L1, and then the cranial inclinometer is placed at T1 and T2. The angle on each of the inclinometers is then read and recorded. The thoracic kyphosis angle is calculated by the sum of the two inclinometer readings.

OHSU Knight Cancer Institute

University of Colorado, Denver

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Adenocarcinoma

Endometrial Neoplasms

Carcinoma

Carcinoma, Endometrioid

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Ovarian Neoplasms

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Endocrine System Diseases

Ovarian Cancer

Participants will have endometrioid adenocarcinoma histological diagnosis with planned surgical treatment including hysterectomy in combination with SLN biopsy.

Participants will have undergone surgery and bilateral sentinel lymph node mapping (negative for malignancy)

Part 2 participants will be prospectively followed clinically for relapse for 30 months from the date of surgery for physical examination at post-ops visits.

Physical exam

Nadeem Abu-Rustum, MD

Mario Leitao, MD

Jonathan Cosin, MD

Brian Clomovitz, MD

John Paul Diaz, MD

Robert Holloway, MD

Andrea Mariani, MD

Martin Martino, MD

Alessandro Buda, MD

Tommaso Grassi, MD

Giovanni Scambia, MD

Giuseppe Vizzielli, MD

Ane Gerda, MD, PhD

This study is being done to find out how often endometrial cancer recurs after the standard treatment as well as how often the standard treatment results in a lymphedema.

Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease

SEntinel Lymph Node Endometrial Cancer Trial: A Prospective Multicenter International Single-Arm Observational Trial (SELECT)

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Participants will be assessed every 6 (+/- 2) months for 36 months through routine physical examination

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Next Generation Personalized Neuroblastoma Therapy	NCT02780128	Neuroblastoma Cancer	Biopsy Next Generation... Tumor Scans Bone marrow Tes... Physical Exam Eye Exam Labs Pregnancy Test Interviews ECG Echocardiogram Ribociclib Ceritinib	1 Year - 21 Years	Children's Hospital of Philadelphia
Integrative Health Interventions in Symptom Management of Pediatric Patients	NCT05594693	Cancer Pediatric Cance...	Questionnaire Physical Exam	30 Days - 30 Years	University of Colorado, Denver
Next Generation Personalized Neuroblastoma Therapy	NCT02780128	Neuroblastoma Cancer	Biopsy Next Generation... Tumor Scans Bone marrow Tes... Physical Exam Eye Exam Labs Pregnancy Test Interviews ECG Echocardiogram Ribociclib Ceritinib	1 Year - 21 Years	Children's Hospital of Philadelphia
Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease	NCT04291612	Endometrial Can... Endometrioid Ad... Endometrial Can...	Physical exam	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for physical exam