Overview

This trial is active, not recruiting.

Conditions stage iii ovarian epithelial cancer, stage iii ovarian germ cell tumor, stage iv ovarian epithelial cancer, stage iv ovarian germ cell tumor
Treatments pumvc3-higfbp-2 multi-epitope plasmid dna vaccine, laboratory biomarker analysis
Phase phase 1
Sponsor University of Washington
Collaborator National Cancer Institute (NCI)
Start date March 2012
End date January 2015
Trial size 22 participants
Trial identifier NCT01322802, 134, 7396, NCI-2011-00099, P30CA015704

Summary

This phase I trial is studying the side effects of vaccine therapy in treating patients with stage III-IV or recurrent ovarian cancer. Vaccines made from deoxyribonucleic acid (DNA) may help the body build an effective immune response to kill tumor cells.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients receive pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine ID monthly for 3 months.
pumvc3-higfbp-2 multi-epitope plasmid dna vaccine
Given ID
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Measure
Safety as assessed per Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
time frame: Up to 16 months

Secondary Outcomes

Measure
Immunogenicity, via cellular immune response and humoral immune response, as assessed by the generation of IGFBP-2 specific T cells and IgG antibodies
time frame: Up to 16 months
Epitope spreading with the generation of an IGFBP-2 Th1 immune response
time frame: Up to 16 months
Levels of regulatory T- cells (Tregs) over the course of immunization to detect modulation of Tregs with vaccination
time frame: Up to 16 months
Disease-free survival
time frame: Up to 5 years
Overall survival
time frame: Up to 5 years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Patients with advanced stage (III/IV) or recurrent ovarian cancer who have been treated to complete remission with standard therapies including primary debulking surgery - Cancer antigen 125 (CA-125) level within normal limits for the testing laboratory must be documented 90 days prior to enrollment when the assessment of CA-125 is applicable - Patients must be at least 28 days post cytotoxic chemotherapy, and/or monoclonal antibody therapy, prior to enrollment - Patients must be at least 28 days post systemic steroids prior to enrollment - 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 Cell (WBC) >= 3000/mm^3 - Hemoglobin (Hgb) >= 10 mg/dl - Hematocrit (Hct) >= 28% - Serum creatinine =< 2.0 mg/dl or creatinine clearance > 60 ml/min - Total bilirubin =< 2.5 mg/dl - Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =< 3 times upper limit of normal (ULN) - Blood glucose < 1.5 ULN 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 - Patients with any contraindication to receiving sargramostim (rhuGM-CSF) based products - Ovarian cancer of a low malignant potential phenotype or clear cell histology - 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 - All subjects able to bear children

Additional Information

Official title A Phase I Trial of the Safety and Immunogenicity of a DNA Plasmid Based Vaccine Encoding the Amino Acids 1-163 of Insulin-Like Growth Factor Binding Protein-2 (IGFBP-2) in Patients With Advanced Ovarian Cancer
Principal investigator Mary Disis
Description PRIMARY OBJECTIVES: I. To determine the safety of an insulin like growth factor binding protein 2 (IGFBP-2) Th polyepitope plasmid based vaccine in patients with advanced stage or recurrent ovarian cancer. SECONDARY OBJECTIVES: I. To determine the immunogenicity of IGFBP-2 Th polyepitope plasmid based vaccine in patients with advanced stage or recurrent ovarian cancer. II. To determine whether intermolecular epitope spreading occurs with the generation of an IGFBP-2 specific Th1 immune response. III. To determine whether IGFBP-2 vaccination modulates T regulatory cells. OUTLINE: Patients receive pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine intradermally (ID) monthly for 3 months. After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months, and then every 6 months for 5 years.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University of Washington.