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

DISEASE CHARACTERISTICS:

- Diagnosis of recurrent ovarian epithelial cancer, fallopian tube cancer, or primary
peritoneal cancer

- Relapse may be defined by an increase in CA-125 (measurable or symptomatic
disease not required)

- Tumor expression of NY-ESO-1 is not required

- Any HLA type allowed

- Planning to receive pegylated liposomal doxorubicin hydrochloride as salvage therapy
for recurrent disease

- No CNS metastasis for which other therapeutic options (e.g., radiotherapy) may be
available

PATIENT CHARACTERISTICS:

- Karnofsky performance status of 80-100%

- Life expectancy ≥ 6 months

- Neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Serum creatinine ≤ 2.1 mg/dL

- Serum bilirubin ≤ 2 mg/dL

- AST or ALT ≤ 2.6 times upper limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No immunodeficiency

- No known HIV positivity

- No known allergy or history of life-threatening reaction to sargramostim (GM-CSF)

- No other serious illness (e.g., serious infection requiring antibiotics or bleeding
disorder)

- No history of autoimmune disease (e.g., thyroiditis or lupus) except vitiligo

- No evidence of major organ failure

- No myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or
transient ischemic attack, chest pain or shortness of breath with activity, or other
heart condition currently being treated by a physician

- No mental impairment that may compromise the ability to give informed consent or
comply with study requirements

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas), radiotherapy,
or immunotherapy

- More than 4 weeks since prior participation in any other clinical trial involving
another investigational agent

- No more than 4 prior lines of chemotherapy

- No prior doxorubicin hydrochloride

- No concurrent systemic corticosteroids, antihistamines, nonsteroidal
anti-inflammatory drugs, or other immunosuppressive agents

- Concurrent specific COX-2 inhibitors allowed

- No other concurrent chemotherapy

- Concurrent non-cytotoxic anti-cancer therapy (e.g., hormonal therapy for breast
cancer or tamoxifen therapy for ovarian cancer) allowed