Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Seattle, Washington 98109


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT01322802


Primary Contact:

Principal Investigator
Mary Disis
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98109
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.