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A Phase II Study of Concurrent IGFBP-2 Vaccination and Neoadjuvant Chemotherapy to Increase the Rate of Pathologic Complete Response at the Time of Cytoreductive Surgery (NCT03029611)

National Cancer Institute (NCI)
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.
  • Drug: Carboplatin
    Given IV
    • Blastocarb
    • Carboplat
    • Carboplatin Hexal
    • Carboplatino
    • Carbosin
    • Carbosol
    • Carbotec
    • CBDCA
    • Displata
    • Ercar
    • JM-8
    • Nealorin
    • Novoplatinum
    • Paraplat
    • Paraplatin
    • Paraplatin AQ
    • Paraplatine
    • Platinwas
    • Ribocarbo
  • Procedure: Gynecological Surgical Procedure
    Undergo cytoreductive surgery
    • gynecologic surgery
    • Gynecologic Surgical Procedure
    • gynecologic surgical procedures
    • gynecological surgery
  • Other: Laboratory Biomarker Analysis
    Correlative studies
    • Drug: Paclitaxel
      Given IV
      • Anzatax
      • Asotax
      • Bristaxol
      • Praxel
      • Taxol
      • Taxol Konzentrat
    • Biological: pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine
      Given ID
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      Female
      Accepts Healthy Volunteers
      No
      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
      • Hemoglobin (Hgb) >= 10 g/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
      • 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
      • All subjects able to bear children
      PRIMARY OBJECTIVES:

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

      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.

      1 locations

      United States (1)
      • Fred Hutch/University of Washington Cancer Consortium
        recruiting
        Seattle, Washington, United States, 98109
      Status:
      recruiting
      Type:
      Interventional
      Phase:
      Start:
      02 April, 2017
      Updated:
      30 April, 2017
      Participants:
      56
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