Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin Disease
Ann Arbor Stage I Childhood Hodgkin Lymphoma, Ann Arbor Stage II Childhood Hodgkin Lymphoma, Childhood Nodular Lymphocyte Predominant B-Cell Lymphoma
About this trial
This is an interventional treatment trial for Ann Arbor Stage I Childhood Hodgkin Lymphoma
Eligibility Criteria
Inclusion Criteria: Patients with newly diagnosed, previously untreated, biopsy-proven lymphocyte predominant Hodgkin disease (LPHD) are eligible for this protocol as follows: Diagnosis of LPHD must be made using the Revised European American Lymphoma (REAL)/World Health Organization (WHO) classification criteria and will be confirmed by rapid pathology central review Clinical stages as follows: Stage IA without bulk disease Stage IIA without bulk disease Patients with "B" symptoms or bulk disease are NOT eligible for this study Slides for rapid central pathology review must be sent to the Biopathology Center (BPC) Serum glutamic oxalo-acetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 times upper limit of normal (ULN) Total bilirubin =< 1.5 times ULN Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min Creatinine based on age/gender as follows: No greater than 0.4 mg/dL (for patients 1 to 5 months of age) No greater than 0.5 mg/dL (for patients 6 to 11 months of age) No greater than 0.6 mg/dL (for patients 1 year of age) No greater than 0.8 mg/dL (for patients 2 to 5 years of age) No greater than 1.0 mg/dL (for patients 6 to 9 years of age) No greater than 1.2 mg/dL (for patients 10 to 12 years of age) No greater than 1.4 mg/dL (for female patients >= 13 years of age) No greater than 1.5 mg/dL (for male patients 13 to 15 years of age) No greater than 1.7 mg/dL (for male patients >= 16 years of age) Shortening fraction of >= 27% by echocardiogram or ejection fraction of >= 50% by multigated radionuclide angiogram (MUGA) Lactating females must agree that they will not breastfeed a child if they are to receive chemotherapy or radiation treatment* Female patients of childbearing potential must have a negative pregnancy test if they are to receive chemotherapy or radiation treatment* Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method if they are to receive chemotherapy or radiation treatment* Note: *Pregnant or breastfeeding women with stage I, single involved lymph node and confirmed (by Quality Assurance Review Center [QARC ]) total resection, are eligible for the observation arm only; no chemotherapy or radiation treatment will be administered to pregnant or breastfeeding women No prior chemotherapy More than 30 days since prior systemic corticosteroids No prior radiotherapy All patients and/or their parents or legal guardians must sign a written informed consent
Sites / Locations
- Children's Hospital of Alabama
- University of Alabama at Birmingham Cancer Center
- Phoenix Childrens Hospital
- Banner University Medical Center - Tucson
- Arkansas Children's Hospital
- University of Arkansas for Medical Sciences
- Kaiser Permanente Downey Medical Center
- City of Hope Comprehensive Cancer Center
- Miller Children's and Women's Hospital Long Beach
- Children's Hospital Los Angeles
- UCSF Benioff Children's Hospital Oakland
- Kaiser Permanente-Oakland
- Children's Hospital of Orange County
- Sutter Medical Center Sacramento
- Rady Children's Hospital - San Diego
- UCSF Medical Center-Mount Zion
- UCSF Medical Center-Parnassus
- Harbor-University of California at Los Angeles Medical Center
- Children's Hospital Colorado
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
- University of Connecticut
- Connecticut Children's Medical Center
- Yale University
- Alfred I duPont Hospital for Children
- MedStar Georgetown University Hospital
- Children's National Medical Center
- Lee Memorial Health System
- University of Florida Health Science Center - Gainesville
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
- Nemours Children's Clinic-Jacksonville
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Miami Cancer Institute
- AdventHealth Orlando
- Arnold Palmer Hospital for Children
- Nemours Children's Clinic - Orlando
- Orlando Health Cancer Institute
- Nemours Children's Hospital
- Sacred Heart Hospital
- Johns Hopkins All Children's Hospital
- Saint Joseph's Hospital/Children's Hospital-Tampa
- Saint Mary's Hospital
- Children's Healthcare of Atlanta - Egleston
- Emory University Hospital/Winship Cancer Institute
- Memorial Health University Medical Center
- University of Hawaii Cancer Center
- Kapiolani Medical Center for Women and Children
- Lurie Children's Hospital-Chicago
- University of Illinois
- University of Chicago Comprehensive Cancer Center
- Advocate Children's Hospital-Oak Lawn
- Advocate Children's Hospital-Park Ridge
- Advocate Lutheran General Hospital
- Saint Jude Midwest Affiliate
- Southern Illinois University School of Medicine
- Indiana University/Melvin and Bren Simon Cancer Center
- Riley Hospital for Children
- University of Iowa/Holden Comprehensive Cancer Center
- University of Kansas Cancer Center
- University of Kentucky/Markey Cancer Center
- Norton Children's Hospital
- Tulane University Health Sciences Center
- Eastern Maine Medical Center
- Sinai Hospital of Baltimore
- Johns Hopkins University/Sidney Kimmel Cancer Center
- C S Mott Children's Hospital
- Wayne State University/Karmanos Cancer Institute
- Michigan State University Clinical Center
- Hurley Medical Center
- Helen DeVos Children's Hospital at Spectrum Health
- Spectrum Health at Butterworth Campus
- Bronson Methodist Hospital
- Kalamazoo Center for Medical Studies
- Children's Hospitals and Clinics of Minnesota - Minneapolis
- University of Minnesota/Masonic Cancer Center
- Mayo Clinic in Rochester
- University of Mississippi Medical Center
- Children's Mercy Hospitals and Clinics
- Washington University School of Medicine
- Children's Hospital and Medical Center of Omaha
- University of Nebraska Medical Center
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- Hackensack University Medical Center
- Morristown Medical Center
- Saint Peter's University Hospital
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
- Saint Joseph's Regional Medical Center
- Overlook Hospital
- University of New Mexico Cancer Center
- Albany Medical Center
- Montefiore Medical Center - Moses Campus
- Brooklyn Hospital Center
- Roswell Park Cancer Institute
- The Steven and Alexandra Cohen Children's Medical Center of New York
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- University of Rochester
- State University of New York Upstate Medical University
- New York Medical College
- UNC Lineberger Comprehensive Cancer Center
- Carolinas Medical Center/Levine Cancer Institute
- Novant Health Presbyterian Medical Center
- Duke University Medical Center
- East Carolina University
- Wake Forest University Health Sciences
- Children's Hospital Medical Center of Akron
- Cincinnati Children's Hospital Medical Center
- Rainbow Babies and Childrens Hospital
- Cleveland Clinic Foundation
- Nationwide Children's Hospital
- Dayton Children's Hospital
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
- University of Oklahoma Health Sciences Center
- Legacy Emanuel Children's Hospital
- Legacy Emanuel Hospital and Health Center
- Oregon Health and Science University
- Penn State Milton S Hershey Medical Center
- Penn State Children's Hospital
- Children's Hospital of Philadelphia
- Children's Hospital of Pittsburgh of UPMC
- Rhode Island Hospital
- Prisma Health Richland Hospital
- BI-LO Charities Children's Cancer Center
- Greenville Cancer Treatment Center
- Sanford USD Medical Center - Sioux Falls
- T C Thompson Children's Hospital
- East Tennessee Childrens Hospital
- Vanderbilt University/Ingram Cancer Center
- Texas Tech University Health Sciences Center-Amarillo
- Dell Children's Medical Center of Central Texas
- Driscoll Children's Hospital
- Medical City Dallas Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- Cook Children's Medical Center
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- M D Anderson Cancer Center
- Covenant Children's Hospital
- Methodist Children's Hospital of South Texas
- University of Texas Health Science Center at San Antonio
- Scott and White Memorial Hospital
- Primary Children's Hospital
- University of Vermont and State Agricultural College
- Inova Fairfax Hospital
- Children's Hospital of The King's Daughters
- Seattle Children's Hospital
- Providence Sacred Heart Medical Center and Children's Hospital
- West Virginia University Charleston Division
- Cabell-Huntington Hospital
- Children's Hospital of Wisconsin
- The Children's Hospital at Westmead
- Westmead Hospital
- Royal Brisbane and Women's Hospital
- Women's and Children's Hospital-Adelaide
- Princess Margaret Hospital for Children
- Alberta Children's Hospital
- University of Alberta Hospital
- British Columbia Children's Hospital
- CancerCare Manitoba
- Janeway Child Health Centre
- IWK Health Centre
- McMaster Children's Hospital at Hamilton Health Sciences
- Kingston Health Sciences Centre
- Children's Hospital of Eastern Ontario
- Hospital for Sick Children
- Centre Hospitalier Universitaire Sainte-Justine
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
- Centre Hospitalier Universitaire de Quebec
- Schneider Children's Medical Center of Israel
- Starship Children's Hospital
- Christchurch Hospital
- San Jorge Children's Hospital
Arms of the Study
Arm 1
Experimental
Treatment (surgery, combination chemotherapy, radiotherapy)
COMBINATION CHEMOTHERAPY: Patients receive doxorubicin hydrochloride IV over 10-30 minutes and cyclophosphamide IV over 1 hour on day 1, vincristine IV over 1 minute on days 1 and 8, and prednisone PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiotherapy. IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).