S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma
Condition: Lymphoma; Nonneoplastic Condition
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: 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. Giving more than one
      drug (combination chemotherapy) may kill more cancer cells. G-CSF may help lessen the side
      effects in patients receiving chemotherapy. Imaging procedures, such as fludeoxyglucose F
      18-PET/CT imaging, may help doctors predict how patients will respond to treatment.

      PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well
      it works in assessing response to combination chemotherapy and allow doctors to plan better
      additional further treatment in treating patients with stage III or stage IV Hodgkin
      lymphoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To estimate the 2-year progression-free survival (PFS) of HIV-negative patients with
           stage III-IV Hodgkin lymphoma treated with response-adapted therapy based on
           fludeoxyglucose F 18 (FDG)-PET imaging after 2 courses of doxorubicin hydrochloride,
           bleomycin, vinblastine, and dacarbazine (ABVD).

        -  To estimate the 2-year PFS of patients who are PET-positive after treatment with 2
           courses of ABVD and an escalated dose regimen comprising cyclophosphamide, doxorubicin
           hydrochloride, etoposide, vincristine sulfate, bleomycin, procarbazine hydrochloride,
           and prednisone (BEACOPP).

      Secondary

        -  To estimate the 2-year overall survival (OS) of patients treated with these regimens.

        -  To estimate the response rate (i.e., complete and partial responses) in patients treated
           with these regimens.

        -  To evaluate the toxicity of these response-adapted regimens.

        -  To document the feasibility of centralized, real-time review of FDG-PET imaging for U.S.
           cooperative group studies.

        -  To prospectively evaluate the overall response rate, complete response rate, PFS, and OS
           of HIV-positive patients treated with these response-adapted regimens.

      OUTLINE: This is a multicenter study.

      All patients undergo baseline whole-body fludeoxyglucose F 18 (FDG)-PET/CT imaging before
      beginning chemotherapy. Patients then receive doxorubicin hydrochloride IV, bleomycin IV,
      vinblastine IV, and dacarbazine IV (ABVD) on days 1 and 15. Treatment repeats every 28 days
      for up to 2 courses in the absence of disease progression or unacceptable toxicity. Between
      days 22 and 25 of course 2, patients undergo a second FDG-PET/CT scan to assess response.
      Subsequent therapy is based on FDG-PET/CT scan results. Patients are stratified according to
      FDG-PET positivity (yes vs no). Patients who are FDG-PET-negative continue treatment with
      ABVD for up to 4 additional courses in the absence of disease progression or unacceptable
      toxicity. Patients who are FDG-PET-positive are then further stratified according to HIV
      positivity (yes or no) and receive 1 of the following treatment regimens:

        -  Escalated-dose BEACOPP chemotherapy: HIV-negative patients receive escalated-dose
           BEACOPP chemotherapy comprising doxorubicin hydrochloride IV and cyclophosphamide IV on
           day 1, etoposide IV on days 1-3, oral procarbazine hydrochloride on days 1-7, oral
           prednisone on days 1-14, and bleomycin IV and vincristine IV on day 8. Patients receive
           filgrastim (G-CSF) subcutaneously on days 8-14. Treatment repeats every 21 days for up
           to 6 courses in the absence of disease progression or unacceptable toxicity.

        -  Standard-dose BEACOPP chemotherapy: HIV-positive patients receive standard dose BEACOPP
           chemotherapy comprising doxorubicin hydrochloride IV and cyclophosphamide IV on day 1,
           etoposide IV on days 1-3, oral procarbazine hydrochloride on days 1-7, oral prednisone
           on days 1-14, and bleomycin IV and vincristine IV on day 8. Treatment repeats every 21
           days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

      Six to eight weeks after completion of chemotherapy, patients undergo a post-treatment
      FDG-PET/CT scan.

      Some patients may undergo bone marrow biopsy at 1 month after the last course of
      chemotherapy.

      After completion of study treatment, patients are followed up periodically for 7 years.
    

Intervention name(s): bleomycin sulfate; filgrastim; ABVD regimen; BEACOPP regimen; cyclophosphamide; dacarbazine; doxorubicin hydrochloride; etoposide; prednisone; procarbazine hydrochloride; vinblastine sulfate; vincristine sulfate
Intervention type(s): Biological; Biological; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Prednisone; Cyclophosphamide; Dacarbazine; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine; Bleomycin; Vinblastine; Procarbazine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; adult lymphocyte depletion Hodgkin lymphoma; adult lymphocyte predominant Hodgkin lymphoma; adult mixed cellularity Hodgkin lymphoma; adult nodular sclerosis Hodgkin lymphoma; HIV infection