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Investigational New Drugs

, Volume 19, Issue 4, pp 321–326 | Cite as

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

  • Athanassios Argiris
  • Peter Heald
  • Timothy Kuzel
  • Francine M. Foss
  • Susan DiStasio
  • Dennis L. Cooper
  • Susan Arbuck
  • John R. Murren
Article

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.

9-aminocamptothecin (9-AC) cutaneous T-cell lymphoma indwelling catheter-related infection 

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Copyright information

© Kluwer Academic Publishers 2001

Authors and Affiliations

  • Athanassios Argiris
    • 1
    • 2
  • Peter Heald
    • 3
  • Timothy Kuzel
    • 1
    • 2
  • Francine M. Foss
    • 4
  • Susan DiStasio
    • 3
  • Dennis L. Cooper
    • 3
  • Susan Arbuck
    • 5
  • John R. Murren
    • 3
  1. 1.Northwestern University Medical SchoolUSA
  2. 2.Robert H. Lurie Comprehensive Cancer CenterChicagoU.S.A.
  3. 3.Yale University School of MedicineNew HavenU.S.A.
  4. 4.New England Medical CenterBoston University Medical SchoolBostonU.S.A.
  5. 5.NCI, Investigational Drug Branch, National Cancer InstituteRockvilleU.S.A.

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