Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma
Condition: Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma; Stage III Childhood Hodgkin Lymphoma; Stage IV Childhood Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: bleomycin sulfate; doxorubicin hydrochloride; liposomal vincristine sulfate; vinorelbine tartrate; cyclophosphamide; etoposide phosphate; prednisone; filgrastim; ifosfamide
Intervention description: Given IV or SC; Given IV; Given IV; Given IV; Given IV; Given IV; Given IV; Given IV or SC; Given IV
Intervention MeSH terms: Prednisone; Cyclophosphamide; Ifosfamide; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine; Vinorelbine; Bleomycin; Etoposide phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 166.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      This phase III trial is studying how well giving combination chemotherapy together with
      radiation therapy works in treating young patients with newly diagnosed Hodgkin 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 combination chemotherapy together with radiation therapy
      may kill more cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed newly diagnosed Hodgkin lymphoma (HL) meeting one of the
             following criteria:

               -  Classical disease

               -  Nodular lymphocyte-predominant disease

          -  Stage III or IV disease with B symptoms, as defined by ≥ 1 of the following:

               -  Unexplained weight loss > 10% within the past 6 months

               -  Unexplained recurrent fever > 38°C within the past month

               -  Recurrent drenching night sweats within the past month

          -  Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR maximum serum creatinine based
             on age/gender as follows:

               -  0.4 mg/dL (1 to 5 months)

               -  0.5 mg/dL (6 to 11 months)

               -  0.6 mg/dL (12 to 23 months)

               -  0.8 mg/dL (2 to 5 years)

               -  1 mg/dL (6 to 9 years)

               -  1.2 mg/dL (10 to 12 years)

               -  1.5 mg/dL (males) or 1.4 mg/dL (females) (13 to 15 years)

               -  1.7 mg/dL (males) or 1.4 mg/dL (females) (≥ 16 years)

          -  Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age

          -  AST or ALT < 2.5 times ULN for age

          -  Shortening fraction ≥ 27% by ECHO OR ejection fraction ≥ 50% by MUGA (unless due to
             large mediastinal mass from HL)

          -  FEV_1/FVC > 60% by pulmonary function tests (PFT) (unless due to large mediastinal
             mass fromHL)

               -  For children who are unable to cooperate for PFTs, the criteria are:

                    -  No evidence of dyspnea at rest

                    -  No exercise intolerance

                    -  Pulse oximetry > 92% on room air

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No pathologic prolongation of QTc interval (> 450 milliseconds) on 12-lead ECG

          -  No prior chemotherapy, biological response modifiers (e.g., monoclonal antibody
             therapy), or radiotherapy

          -  At least 28 days since prior corticosteroids except for emergent treatment for
             respiratory distress or spinal cord compression, or for treatment of allergy to
             contrast agent required for CT scan

          -  No other concurrent cancer chemotherapy or immunomodulating agents (including
             steroids)

               -  Concurrent corticosteroid therapy as treatment or prophylaxis for anaphylactic
                  reactions allowed

          -  No concurrent pegfilgrastim