Protocol 144

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

Patient Population

Main Criteria Only

  • Patients with newly diagnosed ovarian, fallopian tube or peritoneal cancer that are recommended to receive neoadjuvant chemotherapy with carboplatin and paclitaxel with subsequent cytoreductive surgery.
  • Demonstrate adequate organ function.
  • Have a performance status of 0 to 2 on the ECOG Performance Scale.

Number of Patients

  • A total of 56 patients will be enrolled in two stages.

Study Objectives

Primary Objective

  • To determine whether the addition of an IGFBP-2 vaccine to neoadjuvant chemotherapy increases the rate of complete response induction.

Secondary Objective

  • To determine whether the addition of an IGFBP-2 vaccine to neoadjuvant chemotherapy increases progression free survival at 12 months.

Treatment Information

  • After all screening procedures have been completed (consent, blood draws, history and physical) the paclitaxel will be administered as a 3-hour infusion immediately followed by a 1-hour infusion of carboplatin per standard of care. The IGFBP-2 study vaccine will be administered 2 weeks after each cycle of chemotherapy.
  • A total of 3 chemotherapy cycles and vaccines will be completed prior to surgery.

On-Site Study Visits

  • The IGFBP-2 trial drug will be administered intradermally (under the skin) at the University of Washington Medical Center. The carboplatin and paclitaxel will be administered per standard of care at the patient’s own oncology clinic.
  • Post vaccine follow-up visits will be conducted at approximately 1-2 weeks and 6 months following the final vaccination.

Long-Term Follow-up

  • Information on how the patient is doing will be obtained from the patient’s primary oncologist once a year for 5 years.

Other Procedures During Study Visits

  • History and physical exam
  • Tetanus vaccine at the first visit only
  • Clinical blood tests plus research blood collection for immune monitoring

Study Location:

University of Washington Medical Center | 1959 NE Pacific Street | Seattle, WA 98195

ClinicalTrials.gov Identifier: NCT03029611

Contact Information:
866-932-8588


Email


trialtvg@uw.edu

Clinical Trials Contact

For more information regarding our trials, please call our Patient Coordinator

866-932-8588
Email