Ovarian Cancer Clinical Trial
IGFBP-2 Vaccine and Combination Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Undergoing Surgery
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.
Full Description
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 cycles in the absence of disease progression or unacceptable toxicity. After completion of 3 cycles, 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.
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
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There is 1 Location for this study
Seattle Washington, 98109, United States
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