{"groups":[{"description":"Patients receive cyclophosphamide IV on day 1 and IRX-2 via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection.\n\nCyclophosphamide: Given IV\n\nIndomethacin: Given PO\n\nIRX-2: Given via submucosal injection or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nMultivitamin: Given zinc-containing multivitamin PO\n\nOmeprazole: Given PO\n\nTherapeutic Conventional Surgery: Undergo surgical resection","id":"FG000","title":"Arm I (IRX-2)"},{"description":"Patients receive cyclophosphamide IV on day 1 and placebo via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection.\n\nCyclophosphamide: Given IV\n\nIndomethacin: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nMultivitamin: Given zinc-containing multivitamin PO\n\nOmeprazole: Given PO\n\nPlacebo: Given via submucosal injections or SC\n\nTherapeutic Conventional Surgery: Undergo surgical resection","id":"FG001","title":"Arm II (Placebo)"}],"periods":[{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"3"}],"comment":"Arm I patients CIN3 = 6 VIN3 = 1","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"3"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"recruitmentDetails":"The study began recruiting in November 2017 and recruitment ended in August 2023. All participants were seen and treated at USC Norris Comprehensive Cancer Center and/or at LAC+USC Medical Center."}