Response-Based Therapy Assessed By PET Scan in Treating Patients With Bulky Stage I and Stage II Classical Hodgkin Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: ABVD; BEACOPP; radiation therapy
Intervention description: doxorubicin 25 mg/m^2 IV bleomycin 10 units/m^2 IV vinblastine 6 mg/m^2 IV dacarbazine 375 mg/m^2 IV; bleomycin 10 units/m^2 IV on Day 8 etoposide 200 mg/m^2 IV on Days 1, 2 and 3 doxorubicin 35 mg/m^2 IV on Day 1 cyclophosphamide 1250 mg/m^2 IV on Day 1 vincristine 1.4 mg/m^2 IV on Day 8 procarbazine 100 mg/m^2 orally on Days 1-7 prednisone 40 mg/m^2 orally on Days 1-14
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma; adult favorable prognosis Hodgkin lymphoma; adult lymphocyte depletion Hodgkin lymphoma; adult lymphocyte predominant Hodgkin lymphoma; adult mixed cellularity Hodgkin lymphoma; adult nodular sclerosis Hodgkin lymphoma; adult unfavorable prognosis Hodgkin lymphoma

Summary:

      This research is being done in order to improve treatment outcomes in patients diagnosed with
      bulky, early stage Hodgkin lymphoma and to reduce the side effects that are associated with
      use of radiation used in current treatments. The chemotherapy treatment in this study
      consists of a combination of four drugs approved by the Food and Drug Administration (FDA):
      doxorubicin, bleomycin, vinblastine, and dacarbazine. This regimen (called ABVD) has been
      found to be effective in treating patients with Hodgkin lymphoma and is considered the
      standard of treatment used with radiation therapy in patients with bulky early stage Hodgkin
      lymphoma. As part of the evaluation of the effectiveness of the chemotherapy treatment, PET
      scans will be obtained during the course of therapy. The usefulness of this PET scan will be
      evaluated to determine whether radiation may be left out in the treatment of disease if the
      PET scan shows that the patient has responded to chemotherapy alone. The plan is to identify
      a group of patients using early PET scans in order to change to a chemotherapy treatment
      called BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine,
      procarbazine and prednisone). It is one of the most highly effective chemotherapy regimens
      for Hodgkin lymphoma, but is associated with more side effects than ABVD. Although it has
      become standard of care in Europe, its use has been more limited in the U.S. because of
      concerns about toxicity.
    

Eligibility criteria:

        1. Documentation of Disease:

               -  Histologically documented Hodgkin lymphoma subclassified according to the WHO
                  modification of the Rye Classification and staged according to the modified Ann
                  Arbor Staging Classification system.

                    -  Patients must have clinical stage IA, IB, IIA or IIB.

                    -  Patients with "E" extensions will be eligible if all other criteria have
                       been met.

                    -  Nodular lymphocyte predominant Hodgkin lymphoma is excluded.

                    -  Core needle biopsies are acceptable if they contain adequate tissue for
                       primary diagnosis and immunophenotyping. Fine needle aspirates are not
                       acceptable. If multiple specimens are available, please submit the most
                       recent. Failure to submit pathology materials within 60 days of patient
                       registration will be considered a major protocol violation.

               -  Patients must have a mediastinal mass > 0.33 maximum intrathoracic diameter on
                  standing postero-anterior chest x-ray or mass measuring > 10 cm in its largest
                  diameter.

          2. Second Malignancy: No "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.

          3. Prior Therapy - Patients may have had one cycle only of ABVD prior to enrolling on
             study. No other prior treatment (chemotherapy or radiation therapy) for Hodgkin
             lymphoma is allowed. If patient has had one cycle of ABVD, in order to be eligible to
             enroll on CALGB 50801, the patient must have had all of the following tests prior to
             starting the first cycle of ABVD:

               -  LVEF by ECHO or MUGA

               -  PFTs (including DLCO/FVC)CT scan (neck*, chest, abdomen, pelvis)

               -  FDG-PET/CT scan

               -  Chest X-ray, PA & Lateral

               -  CBC, differential, platelets

               -  ESR

               -  Serum creatinine

               -  Glucose

               -  AST

               -  Alkaline phosphatase

               -  Bilirubin

               -  LDH

             Patients with a negative FDG-PET/CT scan do not need to have had a dedicated neck CT
             scan prior to starting the previous cycle of ABVD.

          4. ECOG Performance status 0-2.

          5. LVEF and DLCO - LVEF by ECHO or MUGA within institutional normal limits unless thought
             to be disease related. DLCO ≥ 60% with no symptomatic pulmonary disease unless thought
             to be disease related.

          6. HIV Infection - Patients with known HIV must have a CD4 count > 350 and be on
             concurrent antiretrovirals. 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. An HIV test is not required for entry on this protocol, but
             is required if the patient is perceived to be at risk.

          7. Pregnancy Restrictions - Non-pregnant and non-nursing. Due to the teratogenic
             potential of the agents used in this study, pregnant or nursing women may not be
             enrolled. Women and men of reproductive potential should agree to use an effective
             means of birth control.

          8. Age Restricitions - Age 18 - 60 years

          9. Initial Required Laboratory Data:

               -  ANC ≥ 1000/μL

               -  Platelet count ≥ 100,000/μL

               -  Serum Creatinine ≤ 2 mg/dL

               -  Bilirubin* ≤ 2 x upper limit of normal

               -  AST ≤ 2 x upper limit of normal* - In the absence of Gilbert's disease