Bortezomib and Gemcitabine Hydrochloride in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: bortezomib; gemcitabine hydrochloride
Intervention MeSH terms: Gemcitabine; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent adult Hodgkin lymphoma

Summary:

      RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes
      needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work
      in different ways to stop the growth of cancer cells, either by killing the cells or by
      stopping them from dividing. Giving bortezomib together with gemcitabine hydrochloride may
      kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine
      hydrochloride works in treating patients with relapsed or refractory Hodgkin's lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed Hodgkin's lymphoma

               -  Recurrent or refractory disease after prior standard combination chemotherapy

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 1 cm by
             physical exam or imaging studies

          -  No history of non-Hodgkin's lymphoma

          -  No history of other hematological malignancy

        PATIENT CHARACTERISTICS:

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Platelet count ≥ 100,000/mm^3

          -  Absolute neutrophil count ≥ 1,000/mm^3

        Hepatic

          -  Bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert's disease or
             involvement by Hodgkin's lymphoma)

          -  AST ≤ 3 times ULN (unless due to involvement by Hodgkin's lymphoma)

        Renal

          -  Creatinine clearance ≥ 30 mL/min

        Cardiovascular

          -  Ejection fraction ≥ 40% by MUGA or echocardiogram (in patients with a history of
             cardiac disease)

        Pulmonary

          -  Must not require supplemental oxygen therapy

        Immunologic

          -  No known HIV infection

          -  No uncontrolled bacterial, viral, or fungal infection

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No other malignancy requiring therapy

          -  No peripheral neuropathy ≥ grade 2 within the past 14 days

          -  No hypersensitivity to boron

          -  No hypersensitivity to mannitol

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  More than 30 days since prior monoclonal antibody therapy for Hodgkin's lymphoma

          -  More than 6 months since prior autologous stem cell transplantation

          -  No prior allogeneic stem cell transplantation

          -  No concurrent sargramostim (GM-CSF)

          -  No concurrent pegfilgrastim or filgrastim (G-CSF)

          -  No concurrent interleukin-11(oprelvekin)

        Chemotherapy

          -  See Disease Characteristics

          -  More than 30 days since prior chemotherapy for Hodgkin's lymphoma

          -  No prior treatment with gemcitabine hydrochloride

        Endocrine therapy

          -  More than 30 days since prior corticosteroid therapy for Hodgkin's lymphoma

          -  No concurrent corticosteroid therapy

        Radiotherapy

          -  More than 30 days since prior radiotherapy for Hodgkin's lymphoma

        Other

          -  No prior treatment with bortezomib

          -  More than 14 days since prior investigational drugs

          -  No other concurrent investigational agents