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This is the category page. Below are all of the research programs that are associated with it
- Abnormal Glucose Tolerance -
CAROTID ARTERY INTIMA MEDIA THICKENING AND INTRA-ABDOMINAL FAT IN ADOLESCENTS WITH OBESITY AND
ABNORMAL GLUCOSE TOLERANCE (Investigator Initiated Protocol)
(2_20080403_118)
This study will compare carotid artery wall thickening and intra-abdominal and liver fat in 3 groups of obese, 12 to 18 year old adolescents with the following features: 1) Normal glucose tolerance; 2) Impaired glucose tolerance; and 3) Type 2 diabetics. Comparisons will be made to healthy normal-weight, age and sex-matched control. Artery and fat assessments will be done with the use of ultrasound and MRI; and blood draws. Participants will not take investigational drugs or use investigational devices as part of this study.
- Acute Myeloid Leukemia -
COG #AAML0531: A PHASE III RANDOMIZED TRIAL OF GEMTUZUMAB OZOGAMICIN (MYLOTARG®) COMBINED WITH CONVENTIONAL CHEMOTHERAPY FOR DE NOVO ACUTE MYELOID LEUKEMIA (AML) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS
(1_20070404_118)
Participants will be randomized to one of two arms. Participants will receive standard chemotherapy, with or without gemtuzumab ozogamicin (GMTZ). Participants Bone Marrow counts to determine how long the participant may stay on the study.
- AML/MDS Pediatric Cancer:
COG: AAML0431 – THE TREATMENT OF DOWN SYNDROME CHILDREN WITH ACUTE MYELOID LEUKEMIA (AML) AND MYELODYSPLASTIC SYNDROME (MDS) UNDER THE AGE OF 4 YEARS
(1_20090601_118)
This study is for children diagnosed with AML/MDS before the age of 4 years old that have Down syndrome. Down syndrome children on other studies appeared to have comparable degrees of toxicity except for significantly higher rates of mucositis and skin toxicity. On this study, Down syndrome participants will be treated with a total of six cycles of therapy, two cycles of intensification etoposide and continuous infusion of Ara-C. For this study the overall total cumulative dose of daunorubicin will be 240mg/m2, which is comparable to other studies.
- Brain Tumor for Children -
COG #ANBL0532: PHASE III RANDOMIZED TRIAL OF SINGLE VS. TANDEM MYELOABLATIVE CONSOLIDATION THERAPY FOR HIGH-RISK NEUROBLASTOMA
(2_20080316_118)
This is a two part study. The first part of the study is called the Induction Phase, during which time this study will test the addition of the combination of chemotherapy, cyclophosphamide/topotecan, to the standard chemotherapy combinations used in this Induction Phase of treatment. Use of cyclophosphmaide and topotecen during the induction phase of treatment is experimental. During the Induction Phase information will be collected, and participants will undergo Stem Cell Collection and surgery to remove their tumor. Part two of the study is called the Consolidation and Maintenance Phase. If there is disease progression, the patient will not be able to participate. You do not have to participate in the second part of the study to participate in the first part of the study. During the second part of the study higher doses of chemotherapy will be used than what is standard of care. During this second part, there will be a Stem Cell Transplant and Radiation Therapy with additional chemotherapy. During both parts, participants will be required to have blood work and required scans/x-rays and MRI’s.
- Brain Tumor in Children -
COG #ACNS0332 EFFICACY OF CARBOPLATIN ADMINISTERED CONCOMITANTLY WITH RADIATION AND ISOTRETINOIN AS A PRO-APOPTOTIC AGENT IN OTHER THAN AVERAGE RISK MEDULLOBLASTOMA/PNET PATIENTS
(1_20090106_118)
This is a randomized, open-label, factorial-designed, multicenter study. Patients are randomized according to location of disease and status. Patients are placed on 1of 4 treatment arms. Arm I will receive standard chemoradiotherapy along with standard maintenance therapy. Arm II will receive standard chemoradiotherapy, plus carboplatin and standard maintenance therapy. Arm III will receive standard chemoradiotherapy, standard maintenance therapy, plus isotretinoin, and continuation therapy with isotretinoin. And, Arm IV will receive standard chemoradiotherapy plus carboplatin, standard maintenance therapy plus isotretinoin, and continuation therapy with isotretinoin. After completion of study treatment, patients are followed periodically for up to 10 years. A total of 300 patients will be accrued for this study.
- Brain Tumor in Children -
COG #ANBL0531: RESPONSE-AND BIOLOGY-BASED THERAPY FOR INTERMEDIATE-RISK NEUROBLASTOMA
(2_20081107_118)
Enrollment in this study requires enrollment in ANBL00B1. All participants with the exception of patients with INSS 4S disease will have an operation to remove as much of the primary tumor and involved lymph nodes as can be done safely. If the participant is found to be at intermediate risk, those participants are enrolled on ANBL0531 and split into Group 2, Group 3 and Group 4. These groups are determined by using clinical and biologic information such as age, INSS stage, MYCN status, INPC histopathology classification, and tumor DNA index. Each group will receive a pre-determined number of cycles and drug combinations. If after enrollment on ANBL00B1 the participant is found not to be eligible for ANBL0531, they may be offered other applicable study participation.
- Children receiving Cisplatin-
COG #ACCL0431 A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children
(1_20081207_118)
This is a multicenter study. Patients are stratified according to age (< 5 years vs ≥ 5 years) and duration of cisplatin infusion (< 2 hours vs ≥ 2 hours). Patients are randomized to 1 of 2 arms to compare the efficacy of sodium thiosulfate vs observation in preventing hearing loss in young patients receiving cisplatin for the treatment of newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, or osteosarcoma. After completion of study, patients are followed periodically for 10 years.
Arm I (drug therapy): Patients receive sodium thiosulfate IV over 15 minutes beginning 6 hours after the completion of each cisplatin infusion. Treatment with sodium thiosulfate continues until the completion of cisplatin therapy.
Arm II (observation): Patients do not receive sodium thiosulfate. Patients undergo audiological assessment at baseline, prior to each course of cisplatin, and then at 4 weeks and 1 year after the last course of cisplatin or other cancer treatment.
- Children receiving Cisplatin-
COG #ACCL0431, A RANDOMIZED PHASE III STUDY OF SODIUM THIOSULFATE FOR THE PREVENTION OF CISPLATIN-INDUCED OTOTOXICITY IN CHILDREN
(1_20081207_118)
This is a multicenter study for participants receiving cisplatin. Participants are randomized to 1 of 2 arms. After completion of study treatment, participants are followed periodically for 10 years. Arm 1 is drug therapy and participants will receive sodium thiosulfate IV over 15 minutes beginning 6 hours after the completion of each cisplatin infusion. Treatment with sodium thiosulfate continues until the completion of cisplatin therapy. Arm II is an observational arm and participants do not receive sodium thiosulfate. All participants will have hearing tests before treatments start, prior to each course of cisplatin, and then at 4 weeks and again at 1 year after the last course of cisplatin or other cancer treatment.
- Children receiving Cisplatin-
COG #ACCL05C1, A GROUP-WIDE, PROSPECTIVE STUDY OF OTOTOXICITY ASSESSMENT IN CHILDREN RECEIVING CISPLATIN CHEMOTHERAPY
(1_20081206_118)
This is a multicenter, prospective, cohort study. Patients undergo hearing tests (conventional, otoscopy, ultrahigh frequency, and otoacoustic emission testing) before the first course of planned cisplatin, before each subsequent course of cisplatin, and 4 weeks after the last dose of cisplatin. Patients who are scheduled to receive hematopoietic progenitor stem cell transplantation undergo hearing tests before the transplantation and 4 weeks after transplantation.
- Cystic Fibrosis -
MASTER PROTOCOL CYSTIC FIBROSIS PATIENT REGISTRY
(2_20070709_118)
The CF Patient Registry is a retrospective chart review of all individuals with a diagnosis of cystic fibrosis cared for at Lehigh Valley Hospital. The information gathered would assist researchers, physicians and other clinicians that care for people with CF to better understand the natural progression of CF, and may result in improvements in treatment and survival. The CF Patient Registry is an ongoing database. There is a January deadline for prior calendar year data entry. The database is continuous.
- Ewing Sarcoma in Children -
COG #AEWS07B1: A COG STUDY FOR COLLECTING AND BANKING EWING SARCOMA SPECIMENS
(1_20080710_118)
This study will collect blood, bone marrow and tumor specimens as well as demographic and clinical data, which will be stored for researchers to use for testing at a later date.
- Hodgkin's Disease in Children -
COG #AHOD04B1: HODGKIN DISEASE (HD) BANKING STUDY
(1_20081108_118)
This study is a registry and specimen collection study. This study is designed to better understand why some people get Hodgkin Disease, and why there is a difference in therapy response, recurrence and complications. Tumor samples will be obtained with the initial diagnostic biopsy and/or at the time of relapse. A total of approximately one to four tablespoons of blood will be taken at various time points during and after treatment.
- Kidney Tumor in Children -
COG #ANEN0532: TREATMENT FOR VERY LOW AND STANDARD RISK FAVORABLE HISTOLOGY WILMS TUMOR
(1_20080408_118)
All participants on this study must have been enrolled on AREN03B2. There are three arms to this study. Participants will receive nephrectomy and observation only; or chemotherapy alone; or chemotherapy with radiation therapy. Most participants will have had total resection of the kidney and tumor. Patients with unresectable or incompletely resected tumors will receive chemotherapy and be re-evaluated following 2 cycles (approximately 6 weeks). If the tumor is determined to be resectable, further surgery will be performed.
- Kidney Tumor in Children -
COG #AREN0533: TREATMENT OF NEWLY DIAGNOSED HIGHER RISK FAVORABLE HISTOLOGY WILMS TUMOR
(1_20080707_118)
This is associated with a previously approved study AREN0532. This study is for participants that have been on AREN0532 that have Stage III disease and are found to have loss of heterozygosity at chromosome 1p and 16q, which makes them no longer eligible for AREN0532. Participants can be transferred to this study and will be placed on regimen DD4A or regimen M depending on stage of disease. Participants will receive FDA approved drugs.
- Oral Health for Children -
SCHOOL-BASED ORAL HEALTH PHASE III DENTAL SEALANT APPLICATION
(1_20080906_118)
This study will take place in elementary schools in the Allentown and Easton School Districts. All second grade students in these school districts are eligible to participate. This study will place a dental sealant on the molars of all students enrolled in the study and will follow the students academic history along with absences and PSSA scores. The child’s teacher will present the parent with an information booklet along with a cover letter, permission slip, etc. in either English or Spanish. This phase of the study will last for 4 years.
- Osteosarcoma in Children -
COG #AOST0331: A RANDOMIZED TRIAL OF THE EUROPEAN AND AMERICAN OSTEOSARCOMA STUDY GROUP TO OPTIMIZE TRETMENT STRATEGIES FOR RESECTABLE OSTEOSARCOMA BASED ON HISTOLOGICAL RESPONSE TO PRE-OPERATIVE CHEMOTHERAPY
(1_20081010_118)
This study is for children and young adults with a surgically resectable osteosarcoma. Participants will be given standard treatment with MAP therapy. After 10 weeks of chemotherapy the tumor will be surgically resected. If 90% or more of the tumor is dead, this is considered a good response; less than the 90% is considered a bad response and the chance of cure is not as good. For participants whose response is considered bad, they will then be offered additional drugs, ifosfamide and etoposide with MAP; for participants who have a good response they will be given interferon with MAP.
- Pediatric Cancer - ALL Relapsed CD22 Positive Acute Lymphoblastic Leukemia:
RELAPSED CD22-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA(ALL)
(2_20090508_118)
This study is for patients who have early first relapse of ALL (within 36 months of initial diagnosis). This study will use an experimental drug called Epratuzumab which will be given in addition to current chemotherapy regimens being used to treat this disease.
- Pediatric Cancer: Wilm’s tumor; rhabdomyosarcoma; acute lymphoblastic leukemia (ALL); or Non-Hodgkins Lymphoma:
COG: ACCL0731: GLUTAMIC ACID TO DECREASE VINCRISTINE TOXICITY IN CHILDREN WITH CANCER
(2_20090512_118)
Patients will be randomized to receive either 1-glutamic acid hydrochloride vs placebo along with vincristine containing chemo regimen. Depending on the disease process, participants will receive either a 4 week regimen or a 9 week regimen. Neurologic exams will be give to measure neurotoxicity.
- Registry for Children with Cancer -
COG #ACCRN07: PROTOCOL FOR THE ENROLLMENT ON THE OFFICIAL COG REGISTRY, THE CHILDHOOD CANCER RESEARCH NETWORK (CCRN)
(1_20080202_118)
Any participant that is seen by a member of the COG will be asked for their interest to consent for the patient to be enrolled into the registry.
- Study Closed to Accrual -
Family of Ewing Sarcom Tumors in Children -
COG #AEWS07P1: A PILOT STUDY OF CHEMOTHERAPY INTENSIFICATION BY ADDING VINCRISTINE, TOPOTECAN AND CYCLOPHOSPHAMIDE TO STANDARD CHEMOTHERAPY AGENTS WITH AN INTERVAL COMPRESSION SCHEDULE IN NEWLY DIAGNOSED PATIENTS WITH LOCALIZED EWING SARCOMA FAMILY OF TUMORS
(1_20080909_118)
Participants will receive an experimental combination and dosage, the Induction for 6 cycles, which will be for weeks 1-12. Following the induction cycles, the participants will be evaluated. If the participant has progressive disease the patient will then be taken off protocol. If the participant is having local control with the therapy, the participant may go on for surgery and or radiation therapy and may extend into Continuation therapy. The Continuation therapy will be for 11 cycles of chemotherapy, weeks 15-36. Participants will be evaluated throughout the 11 Continuation cycles and if found to have disease progression will be taken off protocol.
- Study Closed to Accrual:
Oral Health for Children -
SCHOOL BASED ORAL HEALTH – PHASE 2, FULL NEEDS ASSESSMENT (Investigator Initiated Protocol)
(1_20071102_118)
This is a Phase 2 study and will consist of students attending all elementary schools in the Allentown and Easton school districts, from 2nd grade through 5th grade. This phase will consist of a dental assessment to collect baseline data on oral health.
- Study Closed to Accrual: Brain Tumor in Children - COG #ANBL0032: PHASE III RANDOMIZED STUDY OF CHIMERIC ANTIBODY 14.18 (CH14.18) IN HIGH RISK NEUROBLASTOMA FOLLOWING MYELOABLATIVE THERAPY AND AUTOLOGOUS STEM CELL RESCUE
(1_20080603_118)
There are two arms to this study. Participants will be randomized to one of the two arms. Arm A will be given orally isotretinoin; and Arm B will receive orally isotretinoin and immunotherapy. Prior to start of study drug, participants may undergo radiation therapy, tumor evaluation, bone marrow biopsy and additional radiographical studies. In rare cases where there is persistent tumor, a tumor biopsy may be required.
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