Clinical trial NCT00561418 (phase 1, status: completed)
Conditions: lymphoma, small intestine cancer
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, C17.9, C78.4, D37.2, C17.8, D13.30, D13.39, Z12.13
Drugs: vorinostat
SMILES: ONC(=O)CCCCCCC(=O)NC1=CC=CC=C1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Must have received a BEAM (cytarabine, etoposide, melphalan, carmustine)-conditioned
             autologous stem cell transplantation for any of the following high-risk lymphomas:

               -  Diffuse large B-cell lymphoma as defined by:

                    -  Induction failure but with response to salvage therapy

                    -  Relapse less than one year after completion of induction therapy

                    -  Elevated lactate dehydrogenase (LDH) at relapse

                    -  Stage III/IV disease at relapse

                    -  Positive PET scan after induction or salvage therapy

                    -  Age ≤ 75 and ≥ 60 years

               -  Follicular lymphoma as defined by:

                    -  Progressive disease after two or more prior regimens

                    -  Transformed to aggressive lymphoma but still chemotherapy sensitive

                    -  Not felt to be a good candidate for an allogeneic transplantation

               -  Hodgkin lymphoma as defined by:

                    -  Primary refractory disease

                    -  Relapse less than one year after completion of induction therapy

                    -  Relapse with PET-positive disease after salvage therapy

                    -  Relapsed refractory and not felt to be a good candidate for an allogeneic
                       transplantation

               -  Mantle cell lymphoma

                    -  Chemotherapy-sensitive disease after induction therapy

                    -  Chemotherapy-sensitive relapsed disease and not felt to be a good candidate
                       for an allogeneic transplantation

               -  T-cell non-Hodgkin lymphoma (NHL)

                    -  Peripheral T-cell lymphoma not otherwise specified and one or more of the
                       following at diagnosis:

                         -  High LDH

                         -  Marrow involvement

                         -  Age > 60 years

                         -  Low platelet count

                         -  Relapsed chemotherapy-sensitive disease

                    -  Angioimmunoblastic lymphadenopathy with dysproteinemia

                    -  Anaplastic lymphoma kinase-negative anaplastic NHL

                    -  Enteropathy-associated T-cell NHL

                    -  Natural killer (NK)/T-cell NHL and stage III/IV disease at diagnosis

                    -  NK blastic NHL

        PATIENT CHARACTERISTICS:

          -  ECOG (Eastern Cooperative Oncology Group) /WHO performance status 0-2

          -  ANC (absolute neutrophil count) ≥ 1,000/μL

          -  Platelet count ≥ 75,000/μL

          -  Total bilirubin ≤ 1.5 mg/dL

          -  AST (aspartate aminotransferase)/ALT (Alanine transaminase) ≤ 2 x upper limit of
             normal (ULN)

          -  Serum creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 50 mL/min

          -  No severe or uncontrolled systemic illness

          -  Patients must be able to swallow capsules

          -  Negative pregnancy test

          -  Not pregnant or nursing

          -  Fertile patients must use at least two adequate barrier methods of contraception
             during study and for 90 days after completion of study therapy

          -  No other malignancy within the past 5 years other than nonmelanoma skin cancer,
             carcinoma in situ of the cervix, or a malignancy considered by their physician to be
             at less than 30% risk of relapse

          -  No congenital long QT syndrome

          -  No significant history of uncontrolled cardiac disease (i.e., uncontrolled
             hypertension, unstable angina, myocardial infarction within the past 6 months, or
             uncontrolled congestive heart failure)

          -  No active bacterial, fungal, or viral infection

          -  No known HIV infection

          -  No active hepatitis B and/or hepatitis C infection

          -  No other medical condition, including mental illness or substance abuse, deemed by the
             Investigator(s) to interfere with a patient's ability to sign informed consent,
             cooperate and participate in the study, or interfere with the interpretation of the
             results

        PRIOR CONCURRENT THERAPY:

          -  Recovered from the majority of the toxicities from the autologous transplantation
             (must have returned to their pretransplant baseline or have no greater than grade I
             extramedullary toxicity Common Toxicity Criteria for Adverse Effects[CTCAE 3.0])

          -  No prior treatment with a histone deacetylase (HDAC) inhibitor (e.g., depsipeptide,
             MS-275, LAQ-824, belinostat, valproic acid)

          -  More than 4 weeks since prior and no concurrent class Ia, Ib, or Ic antiarrhythmic
             drugs

          -  No other concurrent antineoplastic chemotherapy or biologic therapy

          -  No concurrent radiotherapy, unless for local control of bone pain

               -  Irradiated area for pain management should be as small as possible and lesions
                  within the irradiated field cannot be used for response

          -  No concurrent use of complementary or alternative medicines that would confound the
             interpretation of toxicities and antitumor activity of vorinostat (SAHA)