A Phase II Study of (IGFBP-2) Vaccine to Prevent Progression After Serologic Detection of Recurrent Ovarian Cancer
This phase II trial studies how well giving the insulin-like growth factor binding protein 2 \[pUMVC3-hIGFBP-2 multi-epitope plasmid deoxyribonucleic acid (DNA) (IGFBP-2)\] vaccine after one dose of carboplatin works to stop ovarian cancer from growing, spreading, or getting worse (progressing) in patients whose cancer recurrence is detected only in the blood (serologic detection) following treatment with platinum chemotherapy. IGFBP-2 is a protein found in ovarian cancer cells. The IGFBP-2 vaccine may help the body build an effective immune response to kill tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It has been shown to activate parts of the immune system that may act against tumors. Giving the IGFBP-2 vaccine after a single dose of carboplatin may be an effective way to stop ovarian cancer from progressing in patients with serologic detection following treatment with platinum chemotherapy.
• Have a diagnosis of ovarian, fallopian tube, or primary peritoneal cancer who have received systemic chemotherapy including platinum-based chemotherapy
• Have a cancer antigen 125 (CA-125) that normalized after first-line therapy
• CA-125 increased to more than twice the upper limit of normal or two times the nadir value after most recent second or later line of treatment
• Have no measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Ascites and pleural effusions are not measurable disease, if asymptomatic
• All patients who are having sex that can lead to pregnancy must agree to contraception for the duration of the study (end of one year follow up). Note: Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or postmenopausal
• Have estimated life expectancy of at least 3 months
• Be willing and able to provide written informed consent/assent for the trial
• Be ≥ 18 years of age on day of signing informed consent
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
• White blood cell (WBC) ≥ 3000/mm\^3 (performed within 14 days of treatment initiation)
• Hemoglobin (Hgb) ≥ 10 g/dl (performed within 14 days of treatment initiation)
• Hematocrit (Hct) ≥ 28% (performed within 14 days of treatment initiation)
• Serum creatinine ≤ 2.0 mg/dl or creatinine clearance \> 60 mL/min (performed within 14 days of treatment initiation)
• Total bilirubin ≤ 2.5 mg/dl (performed within 14 days of treatment initiation)
• Aspartate aminotransferase (AST) ≤ 3 times upper limit of normal (ULN) (performed within 14 days of treatment initiation)
• Blood glucose \< 1.5 ULN (performed within 14 days of treatment initiation)