A Phase II Study of (IGFBP-2) Vaccine to Prevent Progression After Serologic Detection of Recurrent Ovarian Cancer
University of Washington
Summary
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.
Description
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 reson…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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 * All patients who are having s…
Interventions
- BiologicalpUMVC3-hIGFBP-2 Multi-epitope Plasmid DNA Vaccine
Given intradermally
- DrugCarboplatin
Given IV
- ProcedureComputed Tomography
Undergo CT
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedureBiospecimen Collection
Undergo blood sample collection
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington