A Phase I Clinical Trial of NY-ESO-1 Protein Immunization in Combination With 5-AZA-2'-Deoxycytidine (Decitabine) in Patients Receiving Liposomal Doxorubicin for Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

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