Combination Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Lymphoma
Condition: Childhood Favorable Prognosis Hodgkin Lymphoma; Childhood Lymphocyte Depletion Hodgkin Lymphoma; Childhood Mixed Cellularity Hodgkin Lymphoma; Childhood Nodular Sclerosis Hodgkin Lymphoma; Stage I Childhood Hodgkin Lymphoma; Stage II Childhood Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: radiation therapy; doxorubicin hydrochloride; vincristine sulfate; prednisone; cyclophosphamide; ifosfamide; vinorelbine tartrate; dexamethasone; etoposide phosphate; cisplatin; cytarabine; filgrastim
Intervention description: Undergo radiation therapy; Given IV; Given IV; Given orally; Given IV; Given IV; Given IV; Given IV; Given IV; Given IV; Given IV; Given IV or subcutaneously
Intervention MeSH terms: Cytarabine; Dexamethasone; Prednisone; Cyclophosphamide; Ifosfamide; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine; Vinorelbine; Etoposide phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 287.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      This phase III trial is studying how well combination chemotherapy works when given before
      radiation therapy and/or additional chemotherapy in treating young patients with newly
      diagnosed Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop the
      growth of cancer cells, either by killing the cells or by stopping them from dividing.
      Radiation therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug
      (combination chemotherapy) and giving them together with radiation therapy may kill more
      cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed Hodgkin's lymphoma meeting the following criteria:

               -  Newly diagnosed disease

               -  Stage IA OR stage IIA without bulky disease

               -  No lymphocyte-predominant histology

          -  Staging on this study will be determined by the clinical stage; surgical staging is
             strongly discouraged, except for the rare situation of equivocal imaging studies below
             the diaphragm

          -  Patients may not have received any previous chemotherapy or radiation therapy;
             patients may not have received systemic corticosteroids within 30 days of enrollment
             on this protocol; steroids used for treatment of contrast agent allergy required for
             computed tomography (CT) scans are acceptable

          -  Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
             mL/min/1.73 m^3

          -  Total bilirubin =< 1.5 x normal

          -  Alanine (ALT) =< 2.5 x normal

          -  Shortening fraction >= 27% by echocardiogram OR ejection fraction >= 50% by
             multi-gated acquisition (MUGA)

          -  No pathologic prolongation of QTc interval on 12-lead electrocardiography (ECG)

          -  Female patients of childbearing potential must have a negative pregnancy test

          -  Lactating females must agree that they will not breastfeed a child while on this study

          -  Fertile patients must use effective contraception

          -  Males and females of reproductive potential may not participate unless they have
             agreed to use an effective contraceptive method

          -  All patients and/or their parents or legal guardians must sign a written informed
             consent

          -  All institutional, Food and Drug Administration (FDA), and National Cancer Institute
             (NCI) requirements for human studies must be met