Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease
Condition: 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
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Bleomycin Sulfate; Cisplatin; Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin Hydrochloride; Etoposide; Filgrastim; Involved-Field Radiation Therapy; Prednisone; Vincristine Sulfate Liposome
Intervention description: Given IV or SC; Given IV; Given IV; Given IV; Given IV; Given IV; Given IV; Given SC; Undergo IFRT; Given orally; Given IV
Intervention MeSH terms: Cytarabine; Dexamethasone; Prednisone; Dexamethasone acetate; Cortisone; Cyclophosphamide; Cisplatin; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine; Etoposide phosphate; Bleomycin; Podophyllotoxin; Lenograstim; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1734.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

          -  Fertile patients must use effective contraception

          -  No prior chemotherapy

          -  At least 1 month since prior corticosteroids except prednisone for respiratory
             distress

          -  No prior radiotherapy