IGFBP-2 Vaccine and Combination Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Undergoing Surgery
Condition: Stage III Fallopian Tube Cancer; Stage III Ovarian Cancer; Stage III Primary Peritoneal Cancer; Stage IIIA Fallopian Tube Cancer; Stage IIIA Ovarian Cancer; Stage IIIA Primary Peritoneal Cancer; Stage IIIB Fallopian Tube Cancer; Stage IIIB Ovarian Cancer; Stage IIIB Primary Peritoneal Cancer; Stage IIIC Fallopian Tube Cancer; Stage IIIC Ovarian Cancer; Stage IIIC Primary Peritoneal Cancer; Stage IV Fallopian Tube Cancer; Stage IV Ovarian Cancer; Stage IV Primary Peritoneal Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Peritoneal Neoplasms
Intervention: Carboplatin; Gynecological Surgical Procedure; Laboratory Biomarker Analysis; Paclitaxel; pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine
Intervention description: Given IV; Undergo cytoreductive surgery; Correlative studies; Given IV; Given ID
Intervention MeSH terms: Paclitaxel; Carboplatin; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well pUMVC3-IGFBP2 plasmid deoxyribonucleic acid (DNA)
      vaccine (IGFBP-2 vaccine) and combination chemotherapy work in treating patients with stage
      III-IV ovarian, fallopian tube, or primary peritoneal cancer undergoing surgery. IGFBP-2 is a
      protein found in the blood and tumor cells of most who have been diagnosed with ovarian
      cancer. Too much IGFBP-2 has been associated with more invasive disease. Vaccines made from
      DNA may help the body build an effective immune response to kill tumor cells that express
      IGFBP-2. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different
      ways to stop the growth of tumor cells, either by killing the cells, by stopping them from
      dividing, or by stopping them from spreading. Giving IGFBP-2 vaccine and combination
      chemotherapy may work better in treating patients with stage III-IV ovarian, fallopian tube,
      or primary peritoneal cancer undergoing surgery.
    

Eligibility criteria:

        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