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Phase II Trial of 9-Aminocamptothecin as a 72-h Infusion in Cutaneous T-Cell Lymphoma

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Abstract

Purpose: To evaluate the role of9-aminocamptothecin (9-AC), a syntheticcamptothecin analog, in advanced cutaneousT-cell lymphoma (CTCL). Methods: Eligible patientshad stage IIB-IV CTCL. 9-AC was infused over 72 h at adose of 1,100 μg/m2 per day (approximately46 μg/m2/h) every 2 weeks, withgranulocyte-colony stimulating factor(G-CSF) support. Results: Twelve patients received atotal of 30 cycles of 9-AC. Nine patients hadstage IV disease, 5 patients hadcirculating Sezary cells, and 2 patientshad evidence of tranformation to alarge cell lymphoma. Most of the patientswere heavily pretreated: 10 had receivedprior chemotherapy (83%), 5 of whom hadreceived 2 or more prior regimens,including a patient who had receivedhigh-dose chemotherapy, and 7 hadpreviously received total-skin electronbeam therapy. The study was prematurelyterminated due to substantial toxicity. Sixpatients (50%) developed an indwellingcentral venous catheter-related infection,5 during a period of neutropenia. Threepatients died due to sepsis 4-8 weeks aftertheir last 9-AC treatment. Two of thesepatients had a previous history ofbacterial sepsis. Four patients (33%)developed grade IV thrombocytopenia. Twopartial responses were observed (responserate 17%), but the duration of responsewas brief, 4-8 weeks. Conclusion: 9-AC at thisschedule and route of administration had activity but resultedin an unacceptable rate of complicatedneutropenia and septic deaths in heavilypretreated patients with advanced CTCL whoare susceptible to catheter-relatedinfections.

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Argiris, A., Heald, P., Kuzel, T. et al. Phase II Trial of 9-Aminocamptothecin as a 72-h Infusion in Cutaneous T-Cell Lymphoma. Invest New Drugs 19, 321–326 (2001). https://doi.org/10.1023/A:1010613912335

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