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
Intervention: bleomycin sulfate; filgrastim; ABVD regimen; BEACOPP regimen; cyclophosphamide; dacarbazine; doxorubicin hydrochloride; etoposide; prednisone; procarbazine hydrochloride; vinblastine sulfate; vincristine sulfate
Intervention MeSH terms: Prednisone; Cyclophosphamide; Dacarbazine; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine; Bleomycin; Vinblastine; Procarbazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 371.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed classical Hodgkin lymphoma (HL) (i.e., nodular sclerosis,
             mixed cellularity, lymphocyte-rich, or lymphocyte-depleted)

               -  Previously untreated stage III or IV disease

               -  No nodular lymphocyte predominant disease

          -  Bidimensionally measurable disease

          -  Adequate biopsy samples from original diagnostic specimen must be available for
             pathologic review

               -  Tissue obtained from core biopsies allowed

               -  No tissue obtained from needle aspirations or cytologies

          -  Must have known HIV status

               -  No multi-drug resistant HIV infection, CD4 counts < 150/μL, or other concurrent
                  AIDS-defining conditions in HIV-positive patients

               -  HIV-positive patients with CD4 counts ≥ 150/μL at the time of enrollment OR
                  documented CD4 count > 250/μL at any time within 8 months prior to HL diagnosis
                  allowed

          -  Must have undergone unilateral or bilateral bone marrow biopsy within the past 42 days

          -  Must have a diagnostic quality CT scan of the chest/abdomen and pelvis AND baseline
             FDG-PET scan within the past 28 days

               -  Combined PET/CT scans required

               -  No older "stand-alone" FDG-PET scans

               -  No low-resolution "localization" CT scans as part of a combined PET/CT scans

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-2

          -  Serum erythrocyte sedimentation rate, lactate dehydrogenase (LDH), hemoglobin,
             albumin, white blood cell count (WBC), and lymphocytes measured within the past 28
             days

          -  Serum estradiol (women only), testosterone (men only), follicle stimulating hormone
             (FSH) and luteinizing hormone (LH) (both men and women) levels must be drawn within 60
             days prior to registration

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception during and for ≥ 6 months after
             completion of study therapy

          -  No significant cardiac abnormalities as assessed by multiple gated acquisition scan
             (MUGA) or ECHO AND cardiac ejection fraction ≥ 45% in patients with a history of
             hypertension or cardiac symptoms

          -  Hepatitis B-negative (i.e., hepatitis B surface antigen-negative or anti-hepatitis B
             core antigen-negative)

               -  Patients immune to or immunized against hepatitis B (i.e., anti-hepatitis B
                  surface antibody-positive) are eligible

          -  Hepatitis C-negative (i.e., anti-hepatitis C antibody-negative)

          -  No significant lung disease with abnormal lung function tests (i.e., diffusing
             capacity of lung for carbon monoxide (DLCO) > 25% below predicted after correction for
             hemoglobin) unless attributable to lymphoma

          -  No requirement for continuous supplemental oxygen therapy

          -  No other prior malignancy except adequately treated basal cell or squamous cell skin
             cancer, in situ cervical cancer, adequately treated stage I or II cancer from which
             the patient is currently in complete remission, or any other cancer from which the
             patient has been disease-free for 5 years

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma

          -  No prior solid organ transplantation