Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease

Completed · Phase 3

Conditions studied: Childhood Lymphocyte-Depleted Classical Hodgkin Lymphoma, Childhood Mixed Cellularity Classical Hodgkin Lymphoma, Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma, Childhood Nodular Sclerosis Classical Hodgkin Lymphoma, Stage I Childhood Hodgkin Lymphoma, Stage II Childhood Hodgkin Lymphoma, Stage III Childhood Hodgkin Lymphoma, Stage IV Childhood Hodgkin Lymphoma

In brief

This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.

Key facts

Study ID

NCT00025259

Run by

Children's Oncology Group

People needed

1734

Starts

2002-09-01

Last updated by the study team

2017-04-12

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with newly diagnosed, pathologically confirmed Hodgkin disease (all histologies) are eligible for this protocol if they meet the following clinical stage guidelines:
• All Stage IB regardless of bulk disease
• All Stage IIB regardless of bulk disease
• Stage IA only with bulk disease
• Stage IIA only with bulk disease
• All Stage IAE, IIAE regardless of bulk disease
• All Stage IIIA, IIIAE, IIIAS, IIIAE+S regardless of bulk disease
• All Stage IVA, IVAE regardless of bulk disease
• May not be staged by laparotomy alone
• Surgically staged patients must also have presurgical staging
• Bilirubin no greater than 1.5 times normal
• SGOT or SGPT less than 2.5 times normal
• Creatinine no greater than 1.5 times normal
• Creatinine clearance greater than 40 mL/min
• Radioisotope glomerular filtration rate greater than 70 mL/min
• Shortening fraction at least 27% by echocardiogram
• Ejection fraction at least 50% by MUGA
• No pathologic prolongation of QTc interval on 12-lead electrocardiogram
• FEV_1/FVC greater than 60% by pulmonary function test
• Pulse oximetry greater than 94%
• No evidence of dyspnea at rest
• No exercise intolerance
• Adequate venous access
• Not pregnant or nursing
• Negative pregnancy test

Where it is running

• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Southern California Permanente Medical Group — Downey, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Children's Hospital Central California — Madera, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Broward Health Medical Center — Fort Lauderdale, Florida, United States
• Lee Memorial Health System — Fort Myers, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
• Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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