Vaccine Therapy in Patients With Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 plaque forming
units [PFU]) on Day 1, followed by monthly subcutaneous injections of rF-NY-ESO-1 (7.41 ×
10^7 PFU) for 6 months (Days 29, 57, 85, 113, 141, and 169) or until observation of
treatment-related ≥ grade 3 toxicity or disease progression. Study injections were
administered during a 28-week evaluation period. Patients returned to the clinic for
follow-up on Day 197 (i.e., 28 days after the last study injection) and every 2 months
thereafter for at least 12 months. In patients with measurable disease, tumor response was
assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.
Patients were monitored continuously for safety for the duration of study participation.

Inclusion Criteria:

1. Histologically documented epithelial carcinoma arising in the ovary, fallopian tube,
or peritoneum, from stage II to IV at diagnosis.

2. Received initial surgery and chemotherapy with at least one platinum-based
chemotherapy regimen.

3. Demonstrated complete response to first line therapy as evidenced by negative clinical
examination, cancer antigen (CA)-125 tumor marker, and computed tomography (CT) scan.
In addition, if second-look surgery was performed, patients must have had no evidence
of microscopic or macroscopic disease. Patients must have been within 6 months of
completing their first line platinum-based chemotherapy. These patients would normally
enter a period of observation as standard management.

4. Tumor expression of 1) NY-ESO-1 by reverse transcription-polymerase chain reaction
(RT-PCR) analysis, preferably, or immunohistochemistry; or 2) LAGE-1 by RT-PCR.

5. Expected survival of at least 6 months.

6. Full recovery from surgery.

7. Karnofsky performance status of 70% or more.

8. Patients must have had the following clinical laboratory results:

- neutrophil count: ≥ 1.5 x 10^9/L

- lymphocyte count: ≥ 0.5 x 10^9/L

- platelet count: ≥ 100 x 10^9/L

- serum creatinine: ≤ 2 mg/dL

- serum bilirubin: ≤ 2 mg/dL

9. Ability to avoid close contact with children < 3 years of age; pregnant or breast
feeding women; individuals with active, or a history of, eczema or atopic dermatitis
or other skin disorders such as burns, chickenpox, shingles, impetigo, herpes, severe
acne, or psoriasis; and immunocompromised individuals (human immunodeficiency virus
[HIV], leukemia, lymphoma, solid organ transplantation, generalized malignancy,
cellular or humoral immunodeficiency syndromes, patients currently receiving cytotoxic
chemotherapies, radiation, or high dose corticosteroids).

10. Have been informed of other treatment options.

11. Age ≥ 18 years.

12. Able and willing to give valid written informed consent.

Exclusion Criteria:

1. Metastatic disease to the central nervous system for which other therapeutic options,
including radiotherapy, may have been available.

2. Other serious illnesses (eg, serious infections requiring antibiotics, bleeding
disorders).

3. History of current eczema or atopic dermatitis.

4. History of autoimmune disease (eg., thyroiditis, lupus).

5. Other acute, chronic, or exfoliative skin conditions such as burns, chickenpox,
shingles, impetigo, herpes, severe acne, or psoriasis.

6. Concomitant systemic treatment with corticosteroids, anti-histamine or non-steroidal
anti-inflammatory drugs. Specific cyclooxygenase-2 inhibitors were permitted.

7. Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry (6
weeks for nitrosoureas).

8. Known HIV positivity.

9. Known allergy or severe reaction to a smallpox (vaccinia) vaccination.

10. Known allergy to eggs, determined by history.

11. 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.

12. Presence of 3 or more of the following risk factors:

- Hypertension

- Hypercholesterolemia

- Diabetes

- A first degree relative (for example, mother, father, brother, sister) who had a
heart condition before the age of 50

- Current cigarette smoker

13. Participation in any other clinical trial involving another investigational agent
within 4 weeks prior to enrollment.

14. Mental impairment that may have compromised the ability to give informed consent and
comply with the requirements of the study.

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