Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Nervous System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Rare Diseases

Lymphoma

Glioblastoma

Glioma

Sarcoma

Hodgkin Disease

Brain Neoplasms

Osteosarcoma

Wilms Tumor

Medulloblastoma

Diffuse Intrinsic Pontine Glioma

Neuroblastoma

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Ependymoma

Rhabdomyosarcoma

Sarcoma, Synovial

Desmoplastic Small Round Cell Tumor

Rhabdoid Tumor

Gliosarcoma

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Neoplasms, Connective and Soft Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Myosarcoma

Lymphosarcoma

Soft Tissue Sarcoma

Hodgkin Lymphoma

Germ Cells Tumors

Wilms' Tumor

Ewing Sarcoma

Brain Tumor, Childhood

Synovial Sarcoma

Neuroepithelioma

Malignant Germ Cell Tumor

Gliomatosis Cerebri

IV dose of CLR 131, increased/decreased by dose level; single or fractionated dose

CLR 131

Jarrod Longcor

The study evaluates CLR 131 in children, adolescents, and young adults with relapsed or refractory malignant solid tumors and lymphoma and recurrent or refractory malignant brain tumors for which there are no standard treatment options with curative potential.

Even with standard, highly toxic multimodality therapies and salvage regimen, most pediatric patients with primary metastatic or relapsed solid tumors are confronted with a poor prognosis. For these patients there is currently no accepted successful treatment regimen. There is a need for new drugs, including targeted radiopharmaceuticals, preferably with cancer-specific uptake and broad applicability for these rare pediatric malignancies.

CLR 131 is a radioiodinated therapeutic that exploits the selective uptake and retention of phospholipid ethers (PLEs) by malignant cells. Cellectar Biosciences' novel cancer-targeted small-molecule compound (CLR1404) is radiolabeled with the isotope iodine-131 (I-131). CLR 131 has demonstrated tumor selective uptake across numerous adult and pediatric cancer cell types. Therapeutic efficacy has been demonstrated in various pediatric and adult-type cancer xenograft models, confirming the ability of CLR 131 to target tumors.

Based on the critical unmet medical need for effective agents with novel mechanisms of action in relapsed pediatric cancers and initial preclinical and clinical experience with radioiodinated CLR1404, Cellectar Biosciences has chosen to assess CLR 131 in a phase 1 pediatric trial.

Dose Escalation Study of CLR 131 in Children, Adolescents, and Young Adults With Relapsed or Refractory Malignant Tumors Including But Not Limited to Neuroblastoma, Rhabdomyosarcoma, Ewings Sarcoma, and Osteosarcoma

An Open-Label, Dose Escalation, Efficacy, and Safety Study of CLR 131 in Children, Adolescents, and Young Adults With Select Solid Tumors, Lymphoma, and Malignant Brain Tumors

DLT will be assessed by physical examination, vital signs, and laboratory values

Dose and regimen to be used in Phase 2 trials of CLR 131 in children, adolescents, and young adults

Response assessment per applicable criteria (e.g., Neuroblastoma Response Criteria (modified); RECIST 1.1; positron emission tomography response criteria in solid tumors (PERCIST); RANO)

Assessment via 131-I/CLR 131 SPECT/CT scans

Time from first infusion of CLR 131 until progression or recurrence of disease

Time from first infusion of CLR 131 until death due to any reason

Assessment of dosimetry via whole body planar imaging

Cellectar Biosciences, Inc.

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Hematologic Diseases

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

Antineoplastic Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

All Drugs and Chemicals

Methotrexate

In the standard intravenous fluid (IVF) protocol, following completion of HDMTX infusion, post HDMTX IVF will be initiated at 125 mL/m2/hr (no maximum mL/hr total rate).

The reduced intravenous fluid (IVF) protocol, post HDMTX IVF will be initiated at 62.5 mL/m2/hr following completion of HDMTX infusion.

Administration of post HDMTX intravenous fluids (IVF)

Intravenous fluids

Cady P Noda, PharmD

To determine whether a reduced volume hydration regimen will lead to a shorter time to methotrexate clearance when compared to a standard intravenous (IV) hydration regimen.

This study uses a prospective randomized controlled crossover study design. Neither patients nor clinicians are blinded to the standard versus reduced intravenous fluids (IVF) regimen. Patients are randomized to begin with standard volume or reduced volume IVF. Over the course of 4 cycles of High Dose Methotrexate (HDMTX), patients alternate between standard and reduced volume post hydration fluids protocols.

The study uses a prospective randomized controlled crossover study design.

Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia

Pilot Study on the Reduced Intravenous Fluids to Improve Clearance of High-Dose Methotrexate (HDMTX) in Children With Lymphoma or Acute Lymphoblastic Leukemia

To determine whether a reduced volume hydration regimen will lead to a shorter time to methotrexate clearance when compared to a standard IV hydration regimen by measuring serum methotrexate levels twenty-four hours following the end of the high dose methotrexate ( HDMTX) infusion, and continuing every twelve hours until the methotrexate level is less than 0.1 micromol/L.

To determine the effect of a reduced volume hydration regimen on markers of kidney toxicity (nephrotoxicity) by evaluating serum creatinine levels from baseline levels as well as the maximum decrease in estimated glomerular filtration rate (GFR) utilizing the modified Schwartz equation, following each HDMTX cycle.

To determine the effect of a reduced volume hydration regimen on markers of fluid overload by evaluating maximum weight gain during each hospitalization, and by evaluating the incidence of NCI Common Terminology Criteria for Adverse Events (CTCAE) version v5.0 ≥ grade 1 clinical sequelae of hydration such as facial edema, pulmonary edema, abdominal distension, extremity edema, and weight gain.

To examine the effects of a reduced volume hydration regimen on treatment schedule by measuring the number of days subsequent therapy is delayed for reasons other than scheduling issues or preferences.

To examine the effects of a reduced volume hydration regimen on development of severe mucositis by measuring the incidence of grade ≥ 3 (CTCAE v5.0) mucositis.

Virginia Commonwealth University

* For assessment of LNS ( cervical , axillary and inguinal LNS ), The choice of transducer is an important consideration when evaluating lymph nodes as higher frequencies provide better resolution for superficial structures
* For color Doppler assessment of the lymph nodes, scanning will be done using the slow frame rate, low pulse repetition frequency
* Assessment features including lymph node location, size, shape, border, echogenicity, calcifications, necrosis or cystic change, and adjacent soft tissue edema

ultrasonography

Hager mohammed abdelhafiez, master

samy abdelaziz sayed, professor

haisam ahmed samy, professor

mohamed moamen elbaroudy, doctor

* To evaluate the accuracy of different sonographic modalities vs PET/CT in assessment of response to therapy in lymphoma patients: both early and late therapeutic response assessment.
* To evaluate whether imaging features of pathologic lymph nodes on PET/CT and ultrasonography have a predictive role before, during and after treatment in comparison to clinical outcome.

Lymphomas are common malignancies in children \[1\]. Lymphomas account for about 5% to 6% of all malignancies \[2\] and include a number of different pathologic subtypes, which arise from the constituent cells of the immune system or from their precursor, lymphoma is now highly treatable. Imaging plays a major role in diagnosis, staging and response making surgical staging unnecessary in most cases \[3\].

The treatment regimen and the prognosis depend on the morphological type of lymphoma and the disease stage \[4\].

PET/CT using (18F) FDG is considered one of the functional imaging techniques used to assess the glucose metabolism in vivo; its use has been widely increased in evaluation of oncology patients being highly sensitive in assessment of malignancy as PET/CT can detect malignancy prior to morphological change\[5\].

Imaging by PET is vastly improved by combining it with CT technology. FDG-PET and CT provide functional and anatomic information, respectively. Integration of both modalities can compensate for the disadvantages of each, and the combination method outperforms , thus PET CT has a proved role for Lymphoma in adult \[6\].

F-FDG PET/CT is now considered the most accurate imaging modality in the management of adult lymphomas. Its value has been well documented for initial staging, at mid chemotherapy, after the end of therapy, and for assessing tumor recurrence in the follow-up \[7,8\].

Diagnostic information obtained from 18F-FDG PET scans changed management in 24% of pediatric oncology patients, including those with lymphoma \[9\].

The sensitivities of FDG-PET for the detection of nodal and extra nodal lesions of lymphoma are 92-100 and 74-78% \[10\].

The formation of multiple lymph node lesions in distant sites is one of the characteristics differentiating this disease from lymph node metastasis of common cancer, and thus the fact that FDG-PET allows whole-body scanning is a strong point in its favor.\[11\].

Ultrasonography is an imaging modality that is favored worldwide because of its precision, portability, practicality, and cost. The use of this technology to distinguish metastatic from benign cervical lymph nodes, this determination has implications for diagnosis, staging, and determining optimal treatment regimens \[12\].

Lymph node enlargement is a common feature of various benign and malignant disorders. It is well recognised that ultrasound is superior to palpation in detecting and characterising subcutaneous lymph nodes, various sonographic modalities can be used for lymph node evaluation, including gray-scale, color Doppler \[13\].

Nodal sonographic features can offer a clue for whether a lymph node contains cancer. Ultrasound provides detailed information about the internal and external features of a lymph node and demonstrates superior sensitivity and specificity in detecting malignant nodes compared with physical examination \[14\].

With the use of color Doppler sonography, the vasculature of the lymph nodes can also be evaluated which provides additional information about the nodes. It has become an effective way to obtain more information about the examined lymph nodes with no appreciable increase in the duration or invasiveness of the examination \[15\].

Different Sonographic Modalities and PET-CT in Pediatric Lymphoma

Different Sonographic Modalities in Compared With PET-CT in Evaluation of Pediatric Lymphoma

To evaluate the accuracy of different sonographic modalities vs PET/CT in assessment of response to therapy in lymphoma patients

Assiut University

principle investigator

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Lung Neoplasms

Stomach Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Hematologic Neoplasms

Liver Neoplasms

Stomach Cancer

Pancreatic Cancer

Quality of Life

Biliary Tract Cancer

Being referred to palliative care team before totally terminating their chemotherapy among adult participants.

Being referred to palliative care team when their last chemotherapy is ended among adult participants.

haven't been under the palliative care among adult participants

receiving the palliative care among pediatric participants

haven't received the palliative care among pediatric participants

Palliative Care Team provide a self-learning booklet, medical treatment and consultation about Advance Care Planning with chemotherapy by oncologist.

Early palliative care

Palliative Care Team provide a routine hospice care the same as other patients who doesn't participate this study after the chemotherapy is totally terminated

Routine hospice care

Young Ho Yun, MD-PhD

This study evaluates the change of quality of life, treatment decision and utilization of health care depending on the use of palliative care in advanced cancer patients by a prospective cohort study. Participants will be separated into different groups by their intentions for using palliative care. Every participant will carry out the questionnaire per 3 months. This cohort study will be ended a year after each participant enrolls. However, if the participant didn't survive during this study, the caregivers will be asked to fill out additional questionnaire after 3 months of the death.

Patients with advanced cancer report physical, emotional, social and economic problems that may be due to the cancer itself or its treatment. Previous studies have shown the benefit of early palliative care in oncology. However, many Korean patients tend to start palliative care late even in general hospital. Because of the late start of palliative care, the burden of medical expenses increases, on the other hand, the quality of life of terminally ill patients decrease.

In this study, the use of palliative care in advanced cancer patients will be evaluated by a prospective cohort study. The goals of this study are as follow:

First, the clinical, psycho-social, and cognitive factors affecting quality of life, decision making, and hospital utilization (palliative medical team medical treatment, hospice and medical care) of patients with advanced stage cancer will be investigated.

Second, this study will explore the effects of age-specific characteristics on quality of life and care.

Third, an index, which reflects age-specific characteristics and predicts the time and content of terminal care will be developed. Improvements on the quality of life and care of patients with advanced stage of cancer or metastatic cancer are expected to establish effective terminal care strategies through this study.

The patients' symptom and quality of life, choice of medical care, advance care planning and caregiver's burden of care will be evaluated every 3 months after confirming the willingness to use palliative care for cancer patients. 3 months after the death, a caregiver evaluation will be conducted and hospice use, medical expenses will be analyzed.

Prospective Cohort Study Depending on the Use of Palliative Care for Advanced Stage of Cancer Patients

Change of Quality of Life, Treatment Decision and Utilization of Health Care Depending on the Use of Palliative Care in Adult and Pediatric Patients With Advanced Stage of Cancer: a Prospective Cohort Study

to measure quality of life of adult patients developed by European Organisation for Research and Treatment of Cancer for Palliative Care

Patients survival and POLST(Physician Order for Life-Sustaining Treatment) documentation whether patients survive during the study period and write POLST documentation (Since POLST has no legal form in Korea, it is based on the format of each institution.)

"Patient Health Questionnaire-9 items" is used as assessment tool to measure depression of both patients and their caregivers by completing the questionnaire.

"Decision Conflict Scale" is used as assessment tool to measure a level of decision conflict in treatment of both patients and their caregivers by completing the questionnaire.

to measure the awareness of patients' status of prognosis in both patients and caregivers through two questions in the questionnaire. The first question is about the idea of the possibility of curing the patient's disease and asks patients thought about whether treatment is available for cure and prolong survival. The second question concerns the life expectancy of the patient.

to measure the perceived holistic health status(physical, mental, social, spiritual and general) in both patients and caregivers. caregivers (The patient is asked to answer the perceived health status into five stages.)

To measure Daily functional skills in elderly only in 65-year or order patients.

Direct medical cost will be collected through National Health Insurance Corporation and Indirect cost will be collected by caregiver's questionnaire. In addition, "EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L)" tool will be included in the patient's questionnaire to measure the condition of patients at the same time.

In order to analyze the cost effectiveness, investigate the frequency of use of early palliative care programs, the use of life-sustaining treatment and hospicee, and the use of complementary and alternative medicine(CAM). CAM include Chinese medicine, aromatherapy, diet, and yoga, etc.

to assess the patient's awareness of advanced care planning and willingness to construct advanced care planning. The preference for palliative care is divided according to the life expectancy. Investigate the preference of palliative care in each case - if the life expectancy is within a year, within a few months, or within a few weeks.

To measure mental, social, spiritual quality of life of both patients and caregivers

"Pediatric Quality of Life Inventory(Peds QL)" will be used as assessment tool for QOL among pediatric patients.

Seoul National University Bundang Hospital

National Cancer Center, Korea

Kyunghee University Medical Center

Severance Hospital

Gyeongsang National University Hospital

Chungnam National University Hospital

Chonbuk National University Hospital

Ewha Womans University Mokdong Hospital

Daegu Fatima Hospital

Chonnam National University Hospital

Keimyung University Dongsan Medical Center

Hallym University Medical Center

Asan Medical Center

National Evidence-Based Healthcare Collaborating Agency

National Institute of Health, Korea

National Clinical Research Coordination Center, Seoul, Korea

Ulsan University Hospital

Seoul National University Hospital

Clinical Professor

Symptoms and General Pathology

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Syndrome

Osteoporosis

Metabolic Syndrome

Insulin Resistance

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Bone Diseases

Bone Diseases, Metabolic

Children and adolescents who have completed treatment of for acute lymphoblastic leukemia (ALL) and lymphoma.

Laura D Bilek, PhD

This project will examine habitual physical activity, bone health, and insulin resistance in pediatric acute lymphocytic leukemia (ALL) and lymphoma cancer survivors at two time points: baseline and 6 months. At the two study timepoints, all study participants will be asked to wear an accelerometer, receive a DXA scan of the lumbar spine and hip, and have blood drawn for analysis. Study participants will be given a gift card stipend for each study visit attended. Study visits will coincide with regular office visits to Children's Hospital Oncology Clinic and the Children's Hospital Survivorship Clinics whenever possible. The potential mechanism by which physical activity mediates bone changes will be explored by concurrently measuring changes in lean/fat mass and metabolic status. This pilot study will provide data to inform the design of a randomized controlled trial to test the effect of a physical activity intervention on bone health in PCS.

Childhood cancer treatments are increasingly effective, leading to dramatic improvements in survival rates. These treatments often have devastating effects on the overall health of pediatric cancer survivors (PCS) since they occur during a critical time of bone growth, including increased risks of poor bone health, fracture, and diabetes. In normal child development, physical activity habits influence bone density and structure, which affect bone strength in adulthood. Despite this well-understood principle of bone development, there are no exercise guidelines for improving bone health in PCS. The long-term goal of this research is to develop an effective exercise intervention to improve bone health after cancer therapy. As a first step, the investigators propose to test the hypothesis that the intensity and amount of ground impact of a child's daily physical activity will influence changes in bone density in PCS. The Specific Aims are to (1) examine the effect of physical activity on lumbar bone density of PCS and to (2) evaluate how physical activity influences bone density. In a prospective cohort study, the investigators will enroll 38 pediatric and adolescent survivors (ages 5-18) of acute lymphoblastic leukemia or lymphoma at any post-treatment time point. Aim 1: At two assessments, baseline and six months later, bone density and structure (by DXA scan, a type of x-ray that can measure bone density and the amount of muscle and fat in the body) and physical activity level (by accelerometry, a device like a fitness tracker) will be evaluated. Each child will be categorized as having low or high physical activity based on accelerometry measures averaged from baseline and six-month assessments. Bone changes (0-6 months) will be compared between low and high activity groups. Aim 2: Evaluate potential mechanisms by which physical activity mediates changes in bone, including the effects of lean mass (measured by DXA) and metabolic health (lipid panel, insulin sensitivity (HOMA-IR, hemoglobin A1c), vitamin D). Long-term impact: This research will provide information as to the types of exercise that impact bone health in PCS. This study will help develop effective, evidence-based exercise therapies. These therapies may help prevent fractures and associated disability, leading to an improvement in the quality of life for survivors of pediatric cancer.

Healthy Bones, Healthy Life: Habitual Physical Activity on Bone & Metabolic Health in Pediatric Cancer Survivors

Healthy Bones, Healthy Life: Effect of Habitual Physical Activity on Bone and Metabolic Health in Pediatric Cancer Survivors

z-score of lumbar Spine bone density- DXA scan

Physical Activity as measured by accelerometry

cholesterol (total, HDL, and LDL) and triglycerides will be measured, which are an indicator of overall cardiovascular health which can impact insulin sensitivity

Fasting Insulin and Fasting Glucose will be combined to calculate the HOMA-IR, which is an indicator of insulin sensitivity

measure of the glycated hemoglobin in blood, which is an indicator of insulin sensitivity

measures the levels of vitamin D in the blood which is an indicator of bone health

University of Nebraska

Delivered daily (Monday-Friday) for two to five weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dose Escalation Study of CLR 131 in Children, Adolescents, and Young Adults With Relapsed or Refractory Malignant Tumors Including But Not Limited to Neuroblastoma, Rhabdomyosarcoma, Ewings Sarcoma, and Osteosarcoma	NCT03478462	Pediatric Solid... Pediatric Lymph... Pediatric Brain... DIPG Neuroblastoma Ewing Sarcoma Rhabdomyosarcom... Osteosarcoma	CLR 131	2 Years - 25 Years	Cellectar Biosciences, Inc.
Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia	NCT03964259	Lymphoma Acute Lymphobla... Pediatric Cance... Pediatric ALL Pediatric Lymph...	Intravenous flu...	1 Year - 17 Years	Virginia Commonwealth University
Different Sonographic Modalities and PET-CT in Pediatric Lymphoma	NCT05343676	Pediatric Lymph...	ultrasonography	1 Year - 16 Years	Assiut University
Prospective Cohort Study Depending on the Use of Palliative Care for Advanced Stage of Cancer Patients	NCT03222258	Stage IV Breast... Stage IV Pancre... Stage IV Colon ... Stage IV Gastri... Stage IV Lung C... Stage IV Liver ... Malignant Hemat... Biliary Cancer ... Pediatric Leuke... Pediatric Lymph... Pediatric Brain... Pediatric Solid...	Early palliativ... Routine hospice...	-	Seoul National University Hospital
Healthy Bones, Healthy Life: Habitual Physical Activity on Bone & Metabolic Health in Pediatric Cancer Survivors	NCT04472286	Acute Lymphobla... Pediatric ALL Pediatric Lymph... Bone Loss Metabolic Syndr... Habitual Physic... Precursor Cell ... Lymphoma Leukemia Lymphoid Leukem... Pediatric Osteoporosis Osteoporosis Ri...		5 Years - 18 Years	University of Nebraska
Proton Radiation for Lymphoma Involving Mediastinum	NCT01751412	Lymphoma	Proton Radiatio...	6 Years -	Massachusetts General Hospital
Prospective Cohort Study Depending on the Use of Palliative Care for Advanced Stage of Cancer Patients	NCT03222258	Stage IV Breast... Stage IV Pancre... Stage IV Colon ... Stage IV Gastri... Stage IV Lung C... Stage IV Liver ... Malignant Hemat... Biliary Cancer ... Pediatric Leuke... Pediatric Lymph... Pediatric Brain... Pediatric Solid...	Early palliativ... Routine hospice...	-	Seoul National University Hospital
Healthy Bones, Healthy Life: Habitual Physical Activity on Bone & Metabolic Health in Pediatric Cancer Survivors	NCT04472286	Acute Lymphobla... Pediatric ALL Pediatric Lymph... Bone Loss Metabolic Syndr... Habitual Physic... Precursor Cell ... Lymphoma Leukemia Lymphoid Leukem... Pediatric Osteoporosis Osteoporosis Ri...		5 Years - 18 Years	University of Nebraska

Spots Global Cancer Trial Database for pediatric lymphoma