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

NCT03029611 | Terminated Phase 2 Results FDA Drug

• 4 other identifiers: 9760NCI-2017-00034RG1717017P30CA015704
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Rate of Pathologic Complete Response (CR)

  The tissue collected at time of cytoreductive surgery, post study treatment, was evaluated by the attending pathologist assigned to look at the tissue for viable tumor cells. The corresponding surgical pathology report was reviewed to evaluate individual pCR (absence of viable tumor cells).

  At the time of cytoreductive surgery after receiving study treatment (vaccinations given intradermally approximately two weeks after each combination chemotherapy for 3 doses.)

Secondary Outcomes (6)

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

  At the time of cytoreductive surgery

• Level of IGFBP-2 Th1 Cells Elicited With Vaccine Assessed by Enzyme-linked Immunosorbent Spot Assay

  Up to 6 months after last vaccine

• Level of Tumor Infiltrating Lymphocytes (TIL) in Tumor

  At the time of cytoreductive surgery after receiving study treatment (vaccinations given intradermally approximately two weeks after each combination chemotherapy for 3 doses.)

• Overall Survival (OS)

  Up to 5 years

• Progression Free Survival (PFS)

  Up to 12 months

Other Outcomes (1)

• Predictive Signature of CR Induction When Vaccinated With an IGFBP-2 Vaccine in Combination With Neoadjuvant Chemotherapy Assessed by Whole Exome Sequencing on Vaccinated Patients' Tumors

  At the time of cytoreductive surgery

Study Arms (1)

Treatment (chemotherapy, IGFBP-2 vaccine)

EXPERIMENTAL

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.

Drug: Carboplatin; Procedure: Gynecological Surgical Procedure; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Biological: pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine

Interventions

Carboplatin DRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Treatment (chemotherapy, IGFBP-2 vaccine)

Gynecological Surgical Procedure PROCEDURE

Undergo cytoreductive surgery

Also known as: gynecologic surgery, Gynecologic Surgical Procedure, gynecologic surgical procedures, gynecological surgery

Treatment (chemotherapy, IGFBP-2 vaccine)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (chemotherapy, IGFBP-2 vaccine)

Paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Treatment (chemotherapy, IGFBP-2 vaccine)

pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine BIOLOGICAL

Given ID

Treatment (chemotherapy, IGFBP-2 vaccine)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Carboplatin; Gynecologic Surgical Procedures; Paclitaxel; Taxes

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Urogenital Surgical Procedures; Surgical Procedures, Operative; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: UWashington (University of Washington)

childj@u.washington.edu

206-616-2305

Study Officials

• John Liao

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Medicine, Division of Oncology

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 24, 2017
• Study Start: April 3, 2017
• Primary Completion: October 17, 2018
• Study Completion: December 10, 2019
• Last Updated: January 14, 2022
• Results First Posted: January 14, 2022

Record last verified: 2021-12

Locations

US (1)