Phase 1 Study of NY-ESO-1 Overlapping Peptides in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Inclusion Criteria:

Histologically documented epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum, stage II to IV at diagnosis, and post-initial cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen.
In second or third stable complete clinical remission, defined as a) stable cancer antigen (CA)-125 < 35 U/ml (defined as CA-125 that had not doubled from the post chemotherapy nadir), b) unremarkable physical examination, and c) no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis. Lymph nodes and/or soft tissue abnormalities ≤ 1.0 cm that are often present in the pelvis were not considered definite evidence of disease.
Expected survival of at least 4 months.
Karnofsky performance scale ≥ 70%.

Laboratory values within the following limits:

Hemoglobin ≥ 10.0 g/dL
Neutrophil count ≥ 1.5 x 10^9/L
Platelet count ≥ 80 x 10^9/L
Serum creatinine ≤ 2.0 mg/dL
Serum bilirubin ≤ 2.5 x institutional upper limit of normal (ULN)
aspartate aminotransferase/alanine aminotransferase ≤ 2.5 x institutional ULN
Age ≥ 18 years.
≥ 4 weeks since completion of prior cytotoxic chemotherapy.
Able and willing to give valid written informed consent

Exclusion Criteria:

Clinically significant heart disease (New York Heart Association Class III or IV).
Serious intercurrent illness, eg, serious infections requiring prolonged parenteral antibiotics or bleeding disorders requiring hospitalization.
Positive stool guaiac excluding hemorrhoids.
Known autoimmune disease (ie, rheumatoid arthritis, ulcerative colitis, etc); or immune deficiency (human immunodeficiency virus, hypogammaglobulinemia); or known active infections with Hepatitis B or Hepatitis C; or receipt of immunosuppressive drugs such as systemic corticosteroids or cyclosporin, etc.
Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ.
History of previous severe allergic reactions to vaccines or unknown allergens.
Mental impairment that may have compromised the ability to give informed consent and comply with the requirements of the study.
Lack of availability for immunological and clinical follow-up assessments.
Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent.
Pregnancy or breast-feeding.
Women of childbearing potential: Refusal or inability to use effective means of contraception.