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.
OUTLINE: Patients receive a single dose of carboplatin intravenously (IV) per standard of care on day -3 or -2 prior to cycle 1. Patients then receive IGFBP-2 vaccine intradermally on day 1 of each cycle. Cycles repeat every 4 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients who complete the original vaccine series may be eligible for up to an additional 3 IGFBP-2 vaccines, after another dose of carboplatin, 18 months after first vaccination. Additionally, patients undergo blood sample collection, computed tomography (CT), and/or magnetic resonance imaging (MRI) throughout the study. After completion of study treatment, patients are followed up at 4 weeks, every 4 weeks for 1 year, and then every 6 months for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Given intradermally
Given IV
Undergo CT
Undergo MRI
Undergo blood sample collection
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
RECRUITINGProgression 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 months
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 months
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 vaccine
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 vaccine
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