Phase I and pharmacologic study of 9-aminocamptothecin colloidal dispersion formulation in patients with refractory or relapsed acute leukemia

Annals of Oncology

Volumn 10, Issue 5, 1999, Pages 577-583

  Vey, N ^a   Kantarjian, H M ^a   Tran, H ^a   Beran, M ^a   O'Brien, S ^a   Bivins, C ^a   Giles, F ^a   Cortes, J ^a   Cheson, B ^b   Arbuck, S ^b   Estey, E ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b NATIONAL CANCER INSTITUTE   (United States)

Author keywords

9 aminocamptothecin; Acute leukemia; Phase I clinical trial; Topoisomerase I inhibitors

Indexed keywords

9 AMINOCAMPTOTHECIN; BILIRUBIN; CREATININE; DNA TOPOISOMERASE INHIBITOR;

ACUTE GRANULOCYTIC LEUKEMIA; ACUTE LYMPHOCYTIC LEUKEMIA; ADULT; AREA UNDER THE CURVE; ARTICLE; BONE MARROW HYPOPLASIA; CHRONIC MYELOID LEUKEMIA; CLINICAL ARTICLE; CLINICAL TRIAL; COLLOID; DIARRHEA; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG FORMULATION; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MUCOSA INFLAMMATION; MYELODYSPLASTIC SYNDROME; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL;

EID: 0033051710     PISSN: 09237534     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1026406920321     Document Type: Article

References (25)

1. Potmesil M, Arbuck SG, Takimoto CH et al. 9-Aminocamptothecin and beyond. Preclinical and clinical studies. Ann NY Acad Sci 1996; 803: 231-46.
2. Hsiang Y, Lihou M, Liu L. Arrest of the replication forks by the stabilized topoisomerase I-DNA cleavable complexes as a mechanism of cell killing by camptothecin. Cancer Res 1989; 49: 5077-82.
3. Nitiss J, Wang J. DNA-topoisomerase targeting antitumor drugs can be studied in yeast. Proc Natl Acad Sci USA 1988; 85: 7501-5.
4. Zhang H, D'Arpa P, Liu L. A model for cell killing by topoisomerase poisons. Cancer Cell 1990; 2: 23-7.
5. Wani MC, Nicholas AW, Wall ME. Plant antitumor agents. 23. Synthesis and antileukemic activity of camptothecin analogues. J Med Chem 1986; 29: 2358-63.
6. Giovanella BC, Hinz HR, Kozielski AJ et al. Complete growth inhibition of human cancer xenografts in nude mice by treatment with 20-(S)-camptothecin. Cancer Res 1991; 51: 3052-5.
7. Giovanella BC, Stehlin JS, Wall ME et al. DNA topoisomerase I-targeted chemotherapy of human colon cancer in xenografts. Science 1989; 246: 1046-8.
8. Pantazis P, Kozielski AJ, Vardeman DM et al. Efficacy of camptothecin congeners in the treatment of human breast carcinoma xenografts. Oncol Res 1993; 5: 273-81.
9. Supko J, Plowman D, Dykes J et al. Relationship between the schedule dependence of 9-amino-20-(S)-camptothecin, (AC, NSC 603071) antitumor activity in mice and its plasma pharmacokinetics. Proc Am Assoc Cancer Res 1992; 33: 432.
10. Takimoto C, Dahut W, Marino M et al. Pharmacodynamics and pharmacokinetics of a 72-hour infusion in adult cancer patients. J Clin Oncol 1996; 15: 1492-501.
11. Rubin E, Wood V, Bharti A et al. Phase I and pharmacokinetic study of a new camptothecin derivative, 9-aminocamptothecin. Clin Cancer Res 1995; 1: 269-76.
12. Dahut W, Harold N, Takimoto C et al. Phase I and pharmacokinetic study of 9-aminocamptothecin given by a 72-hour infusion in adult cancer patients. J Clin Oncol 1996; 14: 1236-44.
13. Jeha S, Kantarjian H, O'Brien S et al. activity of oral and intravenous 9-aminocamtothecin in scid mice engrafted with human leukemia. Leuk Lymph 1998; 32: 159-64.
14. Bennett JM, Catovsky D, Daniel MT et al. Proposals for the classification of the acute leukaemias. French-American-British (FAB) co-operative group. Br J Haematol 1976; 33: 451-8.
15. Siu L, Oza A, Eisenhauer E et al. Phase I and pharmacologic study of 9-aminocamptothecin colloidal dispersion formulation given as a 24-hour continuous infusion weekly times four every five weeks. J Clin Oncol 1998; 16: 1122-30.
16. Smith TL, Lee JJ, Kantarjian HM et al. Design and results of phase I cancer clinical trials: Three-year experience at M.D. Anderson Cancer Center. J Clin Oncol 1996; 14: 287-95.
17. National Cancer Institute: Guideline for Reporting of Adverse Drug Reactions. Bethesda, MD, Division of Cancer Treatment, National Cancer Institute 1988.
18. Beran M, Jeha S, O'Brien S et al. Tallimustine, an effective antileukemic agent in severe combined immunodeficient mouse model of adult myelogenous leukemia, induces remissions in a phase I study. Clin Cancer Res 1997; 3: 2377-84.
19. Estey E, Thall P, David C. Design and analysis of trials of salvage therapy in acute myelogenous leukemia. Cancer Chemother Pharmacol 1997; 40: S9-S12.
20. Takimoto CH, Klecker RW, Dahut WL et al. Analysis of the active lactone form of 9-aminocamptothecin in plasma using solid-phase extraction and high-performance liquid chromatography. J Chromatogr B Biomed Appl 1994; 655: 97-104.
21. D'Argenio DZ, Schumitzky A. A program package for simulation and parameter estimation in pharmacokinetic systems. Comput Programs Biomed 1979; 9: 115-34.
22. Beran M, Kantarjian H, O'Brien S. Topotecan, a topoisomerase I inhibitor, is active in the treatment of myelodysplastic syndrome and chronic myelogenous leukemia. Blood 1996; 88: 2473-9.
23. Beran M, Kantarjian H, Keating M et al. Results of combination chemotherapy with topotecan and high-dose cytosine arabinoside (ara-C) in previously untreated patients with high-risk myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML). Blood 1997; 90: 3852 (Abstr).
24. Kantarjian H, Beran M, Ellis A et al. Phase I study of Topotecan, a new topoisomerase I inhibitor in patients with refractory or relapsed acute leukemia. Blood 1993; 81: 1146-51.
25. Rowinsky E, Adjei A, Donehower R et al. Phase I and pharmacodynamic study of the topoisomerase I-inhibitor topotecan in patients with refractory acute leukemia. J Clin Oncol 1994; 12: 2193-203.