Clinical trial NCT01673217 (phase 1, status: completed)
Conditions: recurrent fallopian tube cancer, recurrent ovarian epithelial cancer, recurrent primary peritoneal cavity cancer
ICD codes: C57.00, C57.01, C57.02, D28.2, H18.523, H18.521, H18.522, H18.529, C30.0, Z12.81, D14.0, C14.8, D37.09, Z86.003, Z85.818
Drugs: decitabine, pegylated liposomal doxorubicin hydrochloride
SMILES: CN(C)\N=N\C1=C(N=CN1)C(N)=O, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O
Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with relapsed epithelial ovarian cancer (including fallopian tube and primary
             peritoneal cancer) who will receive liposomal doxorubicin as salvage therapy for
             recurrent disease

          -  Patients may have received up to four previous lines of chemotherapy

          -  The relapse may be defined by an increase in CA125; there may or may not be either
             measurable or symptomatic disease

          -  Any human leukocyte antigen (HLA) type

          -  No requirement for tumor expression of NY-ESO-1

          -  Karnofsky performance status of > 70%

          -  Not previously treated with doxorubicin

          -  Life expectancy >= 6 months

          -  Hematology and biochemistry laboratory results within the limits normally expected for
             the patient population, without evidence of major organ failure

          -  No immunodeficiency

          -  Have been informed of other treatment options

          -  Able and willing to give valid written informed consent

          -  Neutrophil count >= 1.5 x 10^9

          -  Platelet count >= 100 x 10^9

          -  Serum creatinine =< 2.1 mg/dL

          -  Serum bilirubin =< 2 mg/dL

          -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.6 x upper limit
             of normal (ULN) (normal ranges: AST 15-46 U/L; ALT 11-66 U/L)

        Exclusion Criteria:

          -  Metastatic disease to the central nervous system for which other therapeutic options,
             including radiotherapy, may be available

          -  Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding
             disorders)

          -  History of autoimmune disease (e.g., thyroiditis, lupus) except vitiligo

          -  Concomitant systemic treatment with corticosteroids, anti-histamine or non-steroidal
             anti-inflammatory drugs; specific CQX-2 inhibitors are permitted

          -  Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing
             of study agent (6 weeks for nitrosoureas)

          -  Known human immunodeficiency virus (HIV) positivity

          -  Known allergy or history of life threatening reaction to GM-CSF

          -  Myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or
             transient ischemic attack, chest pain or shortness of breath with activity, or other
             heart conditions being treated by a doctor

          -  Participation in any other clinical trial involving another investigational agent
             within 4 weeks prior to first dosing of study agent

          -  Mental impairment that may compromise the ability to give informed consent and comply
             with the requirements of the study

          -  Lack of availability of a patient for immunological and clinical follow-up assessment