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

NCT ID: NCT03029611

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-03
• Study Completion Date: 2019-12-10

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (chemotherapy, IGFBP-2 vaccine)

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.

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

Given IV

Gynecological Surgical Procedure

Intervention Type: PROCEDURE

Undergo cytoreductive surgery

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Paclitaxel

Intervention Type: DRUG

Given IV

pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine

Intervention Type: BIOLOGICAL

Given ID

Interventions

Carboplatin

Given IV

Intervention Type: DRUG

Gynecological Surgical Procedure

Undergo cytoreductive surgery

Intervention Type: PROCEDURE

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Paclitaxel

Given IV

Intervention Type: DRUG

pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine

Given ID

Intervention Type: BIOLOGICAL

Other Intervention Names

Blastocarb; Carboplat; Carboplatin Hexal; Carboplatino; Carbosin; Carbosol; Carbotec; CBDCA; Displata; Ercar; JM-8; Nealorin; Novoplatinum; Paraplatin; Paraplatin AQ; Paraplatine; Platinwas; Ribocarbo; gynecologic surgery; Gynecologic Surgical Procedure; gynecologic surgical procedures; gynecological surgery; Anzatax; Asotax; Bristaxol; Praxel; Taxol; Taxol Konzentrat

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Mary (Nora) Disis

Professor, Department of Medicine, Division of Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Liao

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2017-00034

Identifier Type: REGISTRY

Identifier Source: secondary_id

RG1717017

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

9760

Identifier Type: -

Identifier Source: org_study_id