IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Washington
About this trial
This phase II trial studies how well giving the insulin-like growth factor binding protein 2 \[pUMVC3-hIGFBP-2 multi-epitope plasmid deoxyribonucleic acid (DNA) (IGFBP-2)\] vaccine after one dose of carboplatin works to stop ovarian cancer from growing, spreading, or getting worse (progressing) in patients whose cancer recurrence is detected only in the blood (serologic detection) following treatment with platinum chemotherapy. IGFBP-2 is a protein found in ovarian cancer cells. The IGFBP-2 vaccine may help the body build an effective immune response to kill tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It has been shown to activate parts of the immune system that may act against tumors. Giving the IGFBP-2 vaccine after a single dose of carboplatin may be an effective way to stop ovarian cancer from progressing in patients with serologic detection following treatment with platinum chemotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have a diagnosis of ovarian, fallopian tube, or primary peritoneal cancer who have received systemic chemotherapy including platinum-based chemotherapy
Have a cancer antigen 125 (CA-125) that normalized after first-line therapy
CA-125 increased to more than twice the upper limit of normal or two times the nadir value after most recent second or later line of treatment
Have no measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Ascites and pleural effusions are not measurable disease, if asymptomatic
Disqualifiers
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment (i.e., day 1)
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (if dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
Short-term administration of systemic steroids (i.e., for allergic reactions or the management of immune-related adverse events [irAEs]) is allowed
Has symptomatic ascites or pleural effusions
Trial design
Design model
Single group
Treatments tested in this trial
pUMVC3-hIGFBP-2 Multi-epitope Plasmid DNA Vaccine
Biological/VaccineGiven intradermally
Carboplatin
DrugGiven IV
Computed Tomography
Procedure/SurgeryUndergo CT
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Treatment groups
26 Participants
are divided into 1 treatment groupGroup A: Treatment (carboplatin, IGFBP-2 vaccine)Experimental treatment 5 interventions
Trial outcomes
Primary outcomes
1
Progression free survival
Will compare the progression free survival based on radiographic imaging at 6 months to historical control rates for this population of patients treated by letrozole or tamoxifen. The comparison of the observed rate of progression free survival at 6 months to the benchmark rate will be conducted by Fisher's exact test. The Kaplan-Meier survival curve will be plotted and the median progression free survival will be compared to the historical progression free survival with Greenwood confidence interval.
Time frame
At 6 monthsSecondary outcomes
1
Radiographic recurrence rate
The comparison of the observed radiographic recurrence rate to the benchmark rate will be conducted by Fisher's exact test.
Time frame
At 6 months2
Predictive value of insulin-like growth factor-binding protein 2 (IGFBP-2) positivity toward the rate of progression free survival
IGFBP-2 expression will be evaluated by approved laboratory assays. Positivity will be defined by elevation above normal reference range per laboratory. The predictive value of IGFBP-2 positivity toward the rate of progression free survival at 6 months will be evaluated by odds ratios computed by logistic regression, first individually and then combined as four strata. Will test the association of individual marker, the combined two marker panel, and the interaction between the two markers.
Time frame
At baseline, 4 weeks post-last vaccine, and 6 months post-first vaccine3
T-cell response and IGFBP-2 accuracy of predicting clinical response
Will evaluate whether adding T-cell response to IGFBP-2 will increase the accuracy of predicting clinical response by comparing the fitness between the two models (one with T-cell response and the other one without T-cell response). Receiver operating characteristic curve and area under the curve (AUC) will be evaluated for different panels of markers and the incremental value of adding a particular marker to AUC performance will be assessed.
Time frame
At baseline, 4 weeks post-last vaccine, and 6 months post-first vaccineSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
The Wayne D. Kuni and Joan E. Kuni Foundation
Collaborator
Source ClinicalTrials.gov