SGN-30 and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
Condition: Adult Lymphocyte Depletion Hodgkin Lymphoma; Adult Lymphocyte Predominant Hodgkin Lymphoma; Adult Mixed Cellularity Hodgkin Lymphoma; Adult Nodular Sclerosis Hodgkin Lymphoma; Recurrent Adult Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: monoclonal antibody SGN-30; placebo; vinorelbine tartrate; pegylated liposomal doxorubicin hydrochloride; gemcitabine hydrochloride; laboratory biomarker analysis; pharmacological study
Intervention description: Given IV; Given IV; Given IV; Given IV; Given IV; Correlative studies; Correlative studies
Intervention MeSH terms: Gemcitabine; Doxorubicin; Liposomal doxorubicin; Vinorelbine; Brentuximab Vedotin; Antibodies; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies the side effects and how well giving monoclonal
      antibody SGN-30 together with combination chemotherapy works in treating patients with
      Hodgkin lymphoma that has returned after a period of improvement or did not respond to
      previous treatment. Monoclonal antibodies, such as SGN-30, may interfere with the ability of
      cancer cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine
      hydrochloride, vinorelbine tartrate, and pegylated liposomal doxorubicin hydrochloride, work
      in different ways to stop the growth of cancer cells, either by killing the cells or by
      stopping them from dividing. Giving monoclonal antibody SGN-30 together with combination
      chemotherapy may kill more cancer cells and shrink tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented CD30-positive classical Hodgkin lymphoma according to the
             World Health Organization (WHO) classification of lymphoid malignancies that is
             recurrent or refractory after at least one prior therapy

               -  Note: Patients with nodular lymphocyte predominant HL are not eligible; all other
                  subtypes including nodular sclerosis, lymphocyte-depleted, lymphocyte rich, and
                  mixed cellularity HL may be enrolled

               -  Core needle biopsies are acceptable if they contain adequate tissue for primary
                  diagnosis and immunophenotyping; bone marrow biopsies as the sole means of
                  diagnosis are not acceptable, but they may be submitted in conjunction with nodal
                  biopsies; fine needle aspirates are not acceptable; if the original diagnostic
                  specimen is not available, specimens obtained at relapse may be submitted; if
                  multiple specimens are available, please submit the most recent; failure to
                  submit pathology specimens within 60 days of patient registration will be
                  considered a major protocol violation

          -  Patients must have relapsed or refractory disease after at least one prior therapy,
             with at least a 3 week interval from the completion of the most recent chemotherapy or
             radiotherapy regimen; recovery to =< grade 1 from all toxicities related to the prior
             treatments is required; patients who have previously received a stem cell transplant
             are permitted to enroll on this study

               -  Prior treatment with an anti-CD30 antibody, gemcitabine, vinorelbine, or
                  pegylated liposomal doxorubicin is not permitted

          -  No uncontrolled angina, no myocardial infarction (MI) within 6 months of study entry,
             and no New York Heart Association (NYHA) class II or greater congestive heart failure
             (CHF)

          -  Baseline left ventricular ejection fraction (LVEF) by multi gated acquisition scan
             (MUGA) or echocardiogram (ECHO) must be >= 45%

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Measurable disease must be present on either physical examination or imaging studies;
             evaluable or non-measurable disease alone is not acceptable

               -  Measurable disease is defined as any lesion that can be accurately measured in at
                  least one dimension (longest diameter to be recorded) as >= 10 mm

               -  Non-measurable disease includes all other lesions, including small lesions (< 10
                  mm) and truly non-measurable lesions

               -  Lesions that are considered non-measurable include the following:

                    -  Bone lesions (lesions, if present, should be noted)

                    -  Bone marrow involvement (if present, this should be noted)

                    -  Ascites

                    -  Pleural/pericardial effusion

                    -  Lymphangitis cutis/pulmonis

          -  Pregnant or nursing women may not be enrolled; women of childbearing potential must
             have a negative serum or urine pregnancy test prior to registration; women and men of
             reproductive potential should agree to use an effective means of birth control

          -  Corrected diffusion capacity of carbon monoxide (DLCO) >= 50%

          -  Absolute neutrophil count (ANC) >= 1,200/uL

          -  Platelet count >= 100,000/uL

          -  Creatinine =< 2.0 mg/dL

          -  Bilirubin =< 2.0 mg/dL

               -  Absent a history of Gilbert's disease

          -  Aspartate aminotransferase (AST) =< 2.0 x upper limits of normal