IGFBP-2 Vaccine and Combination Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Undergoing Surgery

PRIMARY OBJECTIVES:

I. Determine whether the addition of an IGFBP-2 vaccine to neoadjuvant chemotherapy increases
the rate of complete pathologic response (CR).

SECONDARY OBJECTIVES:

I. Determine whether the addition of an IGFBP-2 vaccine to neoadjuvant chemotherapy increases
progression free survival at 12 months.

II. Determine whether the addition of an IGFBP-2 vaccine to neoadjuvant chemotherapy improves
overall survival.

III. To determine whether IGFBP-2 vaccination in combination with chemotherapy increases the
level of tumor infiltrating lymphocytes (TIL) in the tumor.

IV. To assess the level of IGFBP-2 type 1 helper cells (Th1) elicited with vaccination
concurrent with chemotherapy.

EXPLORATORY OBJECTIVES:

I. To explore whether there is a predictive genomic signature for CR induction when IGFBP-2
vaccination is used in combination with chemotherapy.

OUTLINE:

Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 1 hour
followed by IGFBP-2 vaccine intradermally (ID) 2 weeks later. Treatment repeats every 3 weeks
for up to 3 courses in the absence of disease progression or unacceptable toxicity. After
completion of 3 courses, patients then undergo cytoreductive surgery.

After completion of study treatment, patients are followed up at 6 months and then once a
year for 5 years.

Inclusion Criteria:

- Patients with newly diagnosed advanced stage (III/IV) ovarian cancer
(ovarian/fallopian tube/peritoneal cancer) who have been recommended to receive
neoadjuvant carboplatin/paclitaxel chemotherapy with subsequent cytoreductive surgery

- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score
of =< 2

- Patients must have recovered from major infections and/or surgical procedures, and in
the opinion of the investigator, not have any significant active concurrent medical
illnesses precluding protocol treatment

- Estimated life expectancy of more than 6 months

- White blood cells (WBC) >= 3000/mm^3 within 30 days of enrollment to study

- Hemoglobin (Hgb) >= 10 g/dl within 30 days of enrollment to study

- Hematocrit (Hct) >= 28% within 30 days of enrollment to study

- Serum creatinine =< 2.0 mg/dl or creatinine clearance > 60 ml/min within 30 days of
enrollment to study

- Total bilirubin =< 2.5 mg/dl within 30 days of enrollment to study

- Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =< 3
times upper limit of normal (ULN) within 30 days of enrollment to study

- Blood glucose <1.5 ULN within 30 days of enrollment to study

- All patients who are having sex that can lead to pregnancy must agree to contraception
for the duration of the study

- Patients must be at least 18 years of age

Exclusion Criteria:

- Patients with any of the following cardiac conditions:

- Symptomatic restrictive cardiomyopathy

- Unstable angina within 4 months prior to enrollment

- New York Heart Association functional class III-IV heart failure on active
treatment

- Symptomatic pericardial effusion

- Uncontrolled diabetes

- History of (non-infectious) pneumonitis that required steroids or current pneumonitis

- Patients with any contraindication to receiving rhuGM-CSF based products

- Patients with any clinically significant autoimmune disease uncontrolled with
treatment

- Patients who are currently receiving an anti-IGF-IR monoclonal antibody as part of
their treatment regimen

- Patients who are simultaneously enrolled in any other treatment study

- Patients who are pregnant or breastfeeding