{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"Pathologic Complete Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"2"}]}],"title":"Persistent CIN3/VIN3"}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"description":"Complete Response (CR) is defined as absence of intraepithelial neoplasia, Partial Response (PR) is defined as a lower grade of dysplasia than present at baseline (for example, grade 3 decreasing to grade 1).","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":"OG000","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":"OG001","title":"Arm II (Placebo)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All patients who received at least 1 cycle is included. There is no statistical analysis performed.","reportingStatus":"POSTED","timeFrame":"Week 25","title":"Pathologic Response","type":"PRIMARY","unitOfMeasure":"Participants"}