Vaccine Therapy in Treating Patients With Stage III-IV or Recurrent Ovarian Cancer

PRIMARY OBJECTIVES:

I. To determine the safety of an insulin like growth factor binding protein 2 (IGFBP-2) Th
polyepitope plasmid based vaccine in patients with advanced stage or recurrent ovarian
cancer.

SECONDARY OBJECTIVES:

I. To determine the immunogenicity of IGFBP-2 Th polyepitope plasmid based vaccine in
patients with advanced stage or recurrent ovarian cancer.

II. To determine whether intermolecular epitope spreading occurs with the generation of an
IGFBP-2 specific Th1 immune response.

III. To determine whether IGFBP-2 vaccination modulates T regulatory cells.

OUTLINE:

Patients receive pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine intradermally (ID) monthly
for 3 months.

After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months, and
then every 6 months for 5 years.

Inclusion Criteria:

- Patients with advanced stage (III/IV) or recurrent ovarian cancer who have been
treated to complete remission with standard therapies including primary debulking
surgery

- Cancer antigen 125 (CA-125) level within normal limits for the testing laboratory must
be documented 90 days prior to enrollment when the assessment of CA-125 is applicable

- Patients must be at least 28 days post cytotoxic chemotherapy, and/or monoclonal
antibody therapy, prior to enrollment

- Patients must be at least 28 days post systemic steroids prior to enrollment

- 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 Cell (WBC) >= 3000/mm^3

- Hemoglobin (Hgb) >= 10 mg/dl

- Hematocrit (Hct) >= 28%

- Serum creatinine =< 2.0 mg/dl or creatinine clearance > 60 ml/min

- Total bilirubin =< 2.5 mg/dl

- Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =< 3
times upper limit of normal (ULN)

- Blood glucose < 1.5 ULN

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

- Patients with any contraindication to receiving sargramostim (rhuGM-CSF) based
products

- Ovarian cancer of a low malignant potential phenotype or clear cell histology

- 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

- All subjects able to bear children