NCT03029611

IGFBP-2 Vaccine and Combination Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Undergoing Surgery

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	Carboplatin	Given IV
PROCEDURE	Gynecological Surgical Procedure	Undergo cytoreductive surgery
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Paclitaxel	Given IV
BIOLOGICAL	pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine	Given ID

Timeline

• Start date: 2017-04-03
• Primary completion: 2018-10-17
• Completion: 2019-12-10
• First posted: 2017-01-24
• Last updated: 2022-01-14
• Results posted: 2022-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study