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

Brief Title

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

Official Title

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

Brief 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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Rate of Pathologic Complete Response (CR)

Secondary Outcome

 Immunohistochemistry (IHC) Staining for CD3, CD4, CD8, and CD27

Condition

Stage III Fallopian Tube Cancer

Intervention

Carboplatin

Study Arms / Comparison Groups

 Treatment (chemotherapy, IGFBP-2 vaccine)

Description:  Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour followed by IGFBP-2 vaccine 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

April 3, 2017

Completion Date

December 10, 2019

Primary Completion Date

October 17, 2018

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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

John Liao, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03029611

Organization ID

Secondary IDs

NCI-2017-00034

Responsible Party

Principal Investigator

Study Sponsor

University of Washington

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

John Liao, Principal Investigator, Fred Hutch/University of Washington Cancer Consortium

Verification Date

December 2021