Vorinostat in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma
Condition: Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Nodal Marginal Zone Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Recurrence
Intervention: Laboratory Biomarker Analysis; Vorinostat
Intervention description: Correlative studies; Given PO
Intervention MeSH terms: Vorinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well vorinostat works in treating patients with relapsed
      or refractory indolent non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as
      vorinostat, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells
      by blocking some of the enzymes needed for cell growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed relapsed/refractory
             indolent Non-Hodgkin's lymphoma (Included in this category are relapsed/refractory
             follicular center lymphomas grade I, II, III, relapsed /refractory marginal zone
             B-cell lymphoma (nodal and extranodal), relapsed/refractory mantle cell lymphoma)

          -  Patients must have measurable disease by computed tomography (CT) scan. positron
             emission tomography (PET) scan evaluations are desirable but not mandatory, so that
             patients with negative PET scans but measurable disease by CT are eligible

          -  Patients may have had up to four prior chemotherapeutic regimens; steroids alone and
             local radiation do not count as regimens (radiotherapy must have been completed at
             least 14 days prior to starting SAHA); rituxan alone does not count as a regimen,
             however, Bexxar or Zevalin do; the most recent therapy must have failed to induce a
             complete response, or there must be disease progression or recurrence after the most
             recent therapy

          -  Patients may be enrolled who relapse after autologous stem cell transplant if they are
             at least three months after transplant, and after allogeneic transplant if they are at
             least six months post transplant; to be eligible after either type of transplant,
             patients must have achieved platelet counts greater than 100,000/mcL, and white blood
             cell (WBC) greater than 1,000/mcL at some point after their transplant, and should
             have no active related infections (i.e. fungal or viral); in the case of allogeneic
             transplant relapse, there should be no active acute graft versus host disease (GvHD)
             of any grade, and no chronic graft versus host disease other than mild skin, oral, or
             ocular GvHD not requiring systemic immunosuppression

          -  Life expectancy of greater than 3 months

          -  Eastern Cooperative Oncology Group (ECOG) performance status #2 (Karnofsky >= 60%)

          -  Absolute neutrophil count >= 1,000/mcL

          -  Platelets >= 100,000/mcL

          -  Total bilirubin within normal institutional limits; patients with elevation of
             unconjugated bilirubin alone, as in Gilbert's Disease, are eligible

          -  Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate [SGPT]) =< 2.5 x
             institutional upper limit of normal

          -  Creatinine up to and including 2 mg/dl

          -  Premenopausal women must have a negative serum pregnancy test prior to entry on this
             study; the effects of SAHA on the developing human fetus at the recommended
             therapeutic dose are unknown; women of child-bearing potential and men must agree to
             use adequate contraception (hormonal or barrier method of birth control; abstinence)
             prior to study entry and for the duration of study participation; should a woman
             become pregnant or suspect she is pregnant while participating in this study, she
             should inform her treating physician immediately

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients who have had chemotherapy within 4 weeks, rituximab within three months
             (unless there is evidence of progression) or radiotherapy within 2 weeks or those who
             have not recovered from adverse events due to agents administered more than 4 weeks
             earlier are excluded; this does not include use of steroids, which may continue until
             two days prior to enrollment; low dose chlorambucil should be stopped two weeks prior
             to beginning SAHA; valproic acid should be stopped at least two weeks prior to
             enrollment; nitrosoureas and mitomycin should be stopped 6 weeks prior to enrollment

          -  Patients may not be receiving any other investigational agents

          -  Patients with known brain metastases are excluded from this clinical trial unless the
             metastases are controlled after therapy and have not been treated with steroids within
             the past two months

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to SAHA

          -  There must be no plans for the patient to receive concurrent hormonal, biological or
             radiation therapy

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant women are excluded from this study; breastfeeding should be discontinued if
             the mother is treated with SAHA

          -  Human immunodeficiency virus (HIV)-positive patients receiving combination
             antiretroviral therapy are ineligible

          -  Patients with other active malignancies are ineligible for this study