{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"2"}],"units":"Participants"}],"description":"A dose limiting toxicity is all Grade 3 and greater toxicities with the exception of myelosuppression, defined as lymphopenia, neutropenia, decreased hemoglobin, and thrombocytopenia, due to chemotherapy preparative regimen. Aldesleukin expected toxicities as defined in Appendix 2 and 3 of the protocol. Expected chemotherapy toxicities as defined in the pharmaceutical information section. Immediate hypersensitivity reactions (excluding symptomatic bronchospasm and grade 4 hypotension) occurring within 2 hours of cell infusion (related to cell infusion) that are reversible to a grade 2 or less within 24 hours of cell administration with standard therapy. Grade 3 fever. Events that are clearly related to the patient's disease.","groups":[{"description":"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin\n\nFludarabine: Patients will receive Fludarabine 25 mg/m\\^2/day for 5 days.\n\nCyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days\n\nE6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)\n\nAldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).","id":"OG000","title":"HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2"},{"description":"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin\n\nFludarabine: Patients will receive Fludarabine 25 mg/m\\^2/day for 5 days.\n\nCyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days\n\nE6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)\n\nAldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).","id":"OG001","title":"HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2"},{"description":"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin\n\nFludarabine: Patients will receive Fludarabine 25 mg/m\\^2/day for 5 days.\n\nCyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days\n\nE6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)\n\nAldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).","id":"OG002","title":"HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2"},{"description":"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin\n\nFludarabine: Patients will receive Fludarabine 25 mg/m\\^2/day for 5 days.\n\nCyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days\n\nE6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)\n\nAldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).","id":"OG003","title":"HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2"},{"description":"patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin\n\nFludarabine: Patients will receive Fludarabine 25 mg/m\\^2/day for 5 days.\n\nCyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days\n\nE6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)\n\nAldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).","id":"OG004","title":"HPV-16 E6 mTCR PBL MTD + HD IL-2"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"19 months and 7 days","title":"Number of Participants With a Dose Limiting Toxicity (DLT)","type":"SECONDARY","unitOfMeasure":"Participants"}