Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma
Condition: Stage II Childhood Hodgkin Lymphoma; Stage III Childhood Hodgkin Lymphoma; Stage IV Childhood Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: brentuximab vedotin; etoposide; prednisone; doxorubicin; cyclophosphamide; Dacarbazine(R); filgrastim; quality of life assessment; radiation therapy
Intervention description: Given intravenously (IV).; Given IV.; Given orally (PO).; Given IV.; Given IV.; Given IV.; Given subcutaneously (SQ) as clinically indicated.; Quality of life assessment will be done at initial clinical visit, and during chemotherapy, completion of therapy, then at 1 year, 2 years and 5 years. It should take no more than 15-20 minutes to complete. Participation is voluntary by participating institution and by participant.; At the end of chemotherapy and recovery of blood counts, radiotherapy will be given to any involved nodes (if any) that are not in complete remission.
Intervention MeSH terms: Prednisone; Prednisolone; Cyclophosphamide; Dacarbazine; Doxorubicin; Etoposide; Brentuximab Vedotin; Imidazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Pediatric cancer; Hodgkin lymphoma; Targeted therapy; Frontline therapy; Brentuximab vedotin; Quality of Life; OEPA/COPDac

Summary:

      This pilot phase II trial studies how well giving brentuximab vedotin, combination
      chemotherapy, and radiation therapy works in treating younger patients with stage IIB, IIIB
      or IV Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin, can block cancer
      growth in different ways. Some block the ability of cancer to grow and spread. Others find
      cancer cells and help kill them or carry cancer killing substances to them. Drugs used in
      chemotherapy, such as etoposide, prednisone, doxorubicin hydrochloride, cyclophosphamide, and
      dacarbazine, 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 brentuximab vedotin with combination chemotherapy may kill more cancer
      cells and reduce the need for radiation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed, previously untreated CD30+ classical Hodgkin Lymphoma (HL).
             (Participants receiving limited emergent radiation therapy (RT) or steroid therapy -
             maximum of 7 days - because of cardiopulmonary decompensation or spinal cord
             compression will be eligible for protocol enrollment).

          -  Age ≤ 18 years at the time of enrollment (i.e., participants are eligible until their
             19th birthday).

          -  Ann Arbor stage IIB, IIIB, IVA, or IVB.

          -  Adequate renal function based on GFR ≥ 70 ml/min/1.73m^2 or serum creatinine adjusted
             for age and gender.

          -  Adequate hepatic function (total bilirubin < 1.5 x ULN for age, and SGOT/SGPT < 2.5 x
             ULN for age).

          -  Female participant who is post-menarchal must have a negative urine or serum pregnancy
             test.

          -  Female or male participant of reproductive potential must agree to use an effective
             contraceptive method throughout duration of study treatment.

        Exclusion Criteria:

          -  CD30 negative HL.

          -  Has received prior therapy for Hodgkin lymphoma, except as noted above.

          -  Inadequate organ function as described above.

          -  Inability or unwillingness of research participant or legal guardian / representative
             to give written informed consent.