Chemotherapy Based on PET Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Doxorubicin; Bleomycin; Vinblastine; PET; INRT; Dacarbazine; Etoposide; Cyclophosphamide; Vincristine; Procarbazine; Prednisone
Intervention description: IV; IV; IV; fludeoxyglucose F 18 Imaging exam; selective external radiation therapy; IV; IV; May be given orally, IV push, or by IV infusion; IV; PO; PO
Intervention MeSH terms: Prednisone; Cyclophosphamide; Dacarbazine; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine; Etoposide phosphate; Bleomycin; Vinblastine; Podophyllotoxin; Procarbazine; Imidazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma

Summary:

      RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin sulfate,
      vinblastine, dacarbazine, cyclophosphamide, etoposide, procarbazine hydrochloride,
      vincristine sulfate, and prednisone, 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. Comparing results of imaging procedures, such
      as PET scans and CT scans, done before, during, and after chemotherapy may help doctors
      predict a patient's response to treatment and help plan the best treatment.

      PURPOSE: This phase II clinical trial studies how well chemotherapy based on PET/CT scan
      works in treating patients with stage I or stage II Hodgkin lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven classical Hodgkin lymphoma subclassified according to the World
             Health Organization (WHO) Classification of Tumors, 4th edition (2008)

          -  Patients must have clinical stage IA, IB, IIA, or IIB disease

               -  Patients with "E" extensions will be eligible if all other criteria have been met

          -  Patients must have a mediastinal mass > 0.33-cm maximum intrathoracic diameter on
             standing postero-anterior chest x-ray or measuring > 10 cm in its largest diameter on
             axial CT images

          -  Bone marrow biopsy is required

          -  ECOG performance status 0-2

          -  ANC ≥ 1,000/μL

          -  Platelet count ≥ 100,000/μL

          -  Hemoglobin ≥ 10 g/dL

          -  Serum creatinine ≤ 2 mg/dL

          -  Direct bilirubin ≤ 2 mg/dL

          -  AST/ALT ≤ 2 times upper limit of normal

          -  Women of childbearing potential and sexually active males must be strongly advised to
             use an accepted and effective method of contraception

          -  LVEF by ECHO or MUGA normal unless thought to be disease related

          -  DLCO ≥ 60% with no symptomatic pulmonary disease unless thought to be disease related

          -  Patients with a history of intravenous drug abuse, or any behavior associated with an
             increased risk of HIV infection, should be tested for exposure to the HIV virus, and
             an HIV test is required for entry on this protocol

          -  HIV-positive patients are eligible if they have CD4 counts ≥ 400/mm³ and are on
             concurrent antiretrovirals

               -  Patient HIV status must be known prior to registration

               -  HIV-positive patients must not have multi-drug resistant HIV infections; CD4
                  counts < 400/mm³; or other concurrent AIDS-defining conditions

          -  Concurrent antiretroviral therapy for HIV-positive patients (CD4 counts ≥ 400/mm³)
             allowed

        Exclusion Criteria:

          -  Nodular lymphocyte-predominant Hodgkin lymphoma

          -  Pregnant or nursing

          -  "Currently active" second malignancy other than non-melanoma skin cancers

               -  Patients are not considered to have a "currently active" malignancy if they have
                  completed therapy and are considered by their physician to be at less than 30%
                  risk of relapse

          -  Prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma