Clinical trial NCT00275080 (phase 1, status: completed)
Conditions: adult acute myeloid leukemia with 11q23 (mll) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), blastic phase chronic myelogenous leukemia, extranodal marginal zone b-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone b-cell lymphoma, recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, recurrent adult burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, secondary acute myeloid leukemia, splenic marginal zone lymphoma, stage iii adult burkitt lymphoma, stage iii adult diffuse large cell lymphoma, stage iii adult diffuse mixed cell lymphoma, stage iii adult diffuse small cleaved cell lymphoma, stage iii adult immunoblastic large cell lymphoma, stage iii adult lymphoblastic lymphoma, stage iii grade 1 follicular lymphoma, stage iii grade 2 follicular lymphoma, stage iii grade 3 follicular lymphoma, stage iii mantle cell lymphoma, stage iii marginal zone lymphoma, stage iii small lymphocytic lymphoma, stage iv adult burkitt lymphoma, stage iv adult diffuse large cell lymphoma, stage iv adult diffuse mixed cell lymphoma, stage iv adult diffuse small cleaved cell lymphoma, stage iv adult immunoblastic large cell lymphoma, stage iv adult lymphoblastic lymphoma, stage iv grade 1 follicular lymphoma, stage iv grade 2 follicular lymphoma, stage iv grade 3 follicular lymphoma, stage iv mantle cell lymphoma, stage iv marginal zone lymphoma, stage iv small lymphocytic lymphoma, unspecified adult solid tumor, protocol specific, untreated adult acute lymphoblastic leukemia, untreated adult acute myeloid leukemia
ICD codes: R19.5, H35.09, M26.50, M26.59, Q99.8, R06.89, R06.9, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, C83.57, C83.50, C91.01, C91.02, C83.52, C83.56, C83.53, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, D75.1, E26.1, N91.1, N91.4, N94.5, A51.41, A51.43, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509, C83.57, C83.50, C91.01, C91.02, C83.52, C83.56, C83.53, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: vorinostat, decitabine
SMILES: ONC(=O)CCCCCCC(=O)NC1=CC=CC=C1, CN(C)\N=N\C1=C(N=CN1)C(N)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of 1 of the following:

               -  Confirmed relapsed or refractory acute myeloid leukemia (AML) or acute
                  lymphoblastic leukemia (ALL) or chronic myelogenous leukemia in blast crisis
                  (CML-BC)

                    -  Patients with acute promyelocytic leukemia who have relapsed while on
                       tretinoin allowed

                    -  Patients with previously untreated AML who refuse induction chemotherapy
                       allowed

                    -  Patients who are not candidates for aggressive management (those that have
                       medical conditions that prevent the administration of standard curative
                       chemotherapy or those who require an allogeneic bone marrow transplantation
                       for curative therapy but lack an appropriate donor) are allowed

               -  Histologically or cytologically confirmed relapsed or refractory non-Hodgkin's
                  lymphoma (NHL)

               -  Histologically confirmed solid tumor that is metastatic or unresectable or for
                  which standard curative or palliative measures do not exist or are no longer
                  effective

                    -  Clinically or radiologically documented disease

                    -  Patients whose only evidence of disease is tumor marker elevation are not
                       eligible

          -  Patients with AML, ALL, or CML-BC who have cerebral spinal fluid involvement may be
             included

               -  May be treated with intrathecal cytarabine and/or methotrexate prior to and/or
                  during the study

          -  No known brain metastases in patients with solid tumors or NHL

          -  ECOG performance status 0-2

          -  Karnofsky 60-100%

          -  Life expectancy > 12 weeks for patients with solid tumors (including non-Hodgkin's
             lymphoma) and 6 weeks for patients with hematological malignancies

          -  Patients with solid tumors (including NHL) must also have normal marrow function as
             defined below:

               -  Leukocytes ≥ 3,000/mm^3

               -  Absolute neutrophil count ≥ 1,500/mm^3

               -  Platelets ≥ 100,000/mm^3

          -  Creatinine ≤ 150 μmol/L

          -  Creatinine clearance ≥ 60 mL/min

          -  Bilirubin normal

          -  AST/ALT ≤ 2.5 times upper limit of normal (ULN)

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (barrier method of birth control or abstinence) prior to study entry and for the
             duration of study participation

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to vorinostat or other agents used in study

          -  Able to take oral medications

          -  Patients who have a clinical or radiological diagnosis of bowel obstruction are
             ineligible

          -  No ongoing or active infection

          -  No symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No cardiac arrhythmia

          -  No psychiatric illness/social situations that would limit compliance with study
             requirements

          -  No other uncontrolled intercurrent illness

          -  No limitation on the number or types of prior therapy

          -  At least 3 weeks since prior radiotherapy, chemotherapy (6 weeks for nitrosoureas or
             mitomycin C), or molecularly targeted agents

               -  Exceptions may be made for low-dose, non-myelosuppressive radiotherapy

          -  At least 2 weeks since prior valproic acid or any other histone deacetylase inhibitor

          -  Must have recovered from prior therapy

          -  Patients with hematological malignancies may receive hydroxyurea until 24 hours prior
             to starting study medications

          -  Previous surgery is permitted provided that wound healing has occurred

          -  No prior decitabine

          -  No other concurrent investigational agents

          -  No other concurrent investigational or commercial agents or therapies administered
             with the intent to treat the patient's malignancy

          -  No HIV-positive patients receiving combination antiretroviral therapy

          -  No concurrent prophylactic hematopoietic growth factors (e.g. filgrastim [G-CSF],
             sargramostim [GM-CSF], thrombopoietin, or epoetin alfa)

               -  Hematopoietic growth factors colony stimulating factors for the treatment of
                  cytopenia may be permitted at the discretion of the principal investigator