Escalating systemic exposure of continuous infusion topotecan in children with recurrent acute leukemia

Journal of Clinical Oncology

Volumn 14, Issue 5, 1996, Pages 1504-1511

  Furman, W L ^a   Baker, S D ^a   Pratt, C B ^a   Rivera, G K ^a   Evans, W E ^a   Stewart, C F ^a  

^a ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

TOPOTECAN;

ACUTE LEUKEMIA; ADOLESCENT; ADULT; ANTINEOPLASTIC ACTIVITY; ARTICLE; BONE MARROW SUPPRESSION; CANCER CHEMOTHERAPY; CANCER RECURRENCE; CHILD; CLINICAL ARTICLE; CLINICAL TRIAL; FEMALE; HUMAN; INFANT; MALE; MUCOSA INFLAMMATION; PRIORITY JOURNAL;

EID: 0029991006     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1996.14.5.1504     Document Type: Article

References (28)

1. Del Bino G, Skierski JS, Darzynkiewicz Z: Diverse effects of camptothecin, an inhibitor of topoisomerase I, on the cell cycle of lymphocytic (L1210, MOLT-4) and myelogenous (HL-60, KG1) leukemic cells. Cancer Res 50:5746-5750, 1990
2. Creemers GJ, Lund B, Verweij J: Topoisomerase I inhibitors: Topotecan and ir[e]notecan. Cancer Treat Rev 20:73-96, 1994
3. Slichenmyer WJ, Rowinsky EK, Donehower RC, et al: The current status of camptothecin analogues as antitumor agents. J Natl Cancer Inst 85:271-291, 1993
4. Blaney SM, Balis FM, Cole DE, et al: Pediatric phase I trial and pharmacokinetic study of topotecan administered as a 24-hour continuous infusion. Cancer Res 53:1032-1036, 1993
5. Pratt CB, Stewart CF, Santana VM, et al: Phase I study of topotecan for pediatric patients with malignant solid tumors. J Clin Oncol 12:539-543, 1994
6. Tubergen D, Pratt C, Stewart C, et al: Phase I study of topotecan in children with refractory solid tumors: A Pediatric Oncology Group study. Proc Am Soc Clin Oncol 13:A463, 1994 (abstr)
7. Kantarjian HM, 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 81:1146-1151, 1993
8. Rowinsky EK, Adjei A, Donehower RC, et al: Phase I and pharmacodynamic study of the topoisomerase I-inhibitor topotecan in patients with refractory acute leukemia. J Clin Oncol 12:2193-2203, 1994
9. Uckun FM, Stewart CF, Reaman G, et al: In vitro and in vivo activity of topotecan against human B-lineage acute lymphoblastic leukemia cells. Blood 85:2817-2828, 1995
10. Pratt CB: The conduct of phase I-II clinical trials in children with cancer. Med Pediatr Oncol 19:304-309, 1991
11. Evans WE, Rodman JH, Relling MV, et al: Concept of maximum tolerated systemic exposure and its application to Phase HI studies of anticancer drugs. Med Pediatr Oncol 19:153-159, 1991
12. Rodman JH, Abromowitch M, Sinkule JA, et al: Clinical pharmacodynamics of continuous infusion teniposide: Systemic exposure as a determinant of response in a Phase I trial. J Clin Oncol 5:1007-1014, 1987
13. Burns H, Kuhn J, Wall J, et al: Early clinical trials of topotecan, a new topoisomerase I inhibitor. Ann Oncol 3:118, 1992 (abstr)
14. Beijnen JH, Smith BR, Keijer WJ, et al: High-performance liquid chromatographic analysis of the new antitumour drug SK&F 104864-A (NSC 609699) in plasma. J Pharm Biomed Anal 8:789-794, 1990
15. Stewart CF, Baker SD, Heiderman RL, et al: Clinical pharmacodynamics of continuous infusion topotecan in children: systemic exposure predicts hematologic toxicity. J Clin Oncol 12:1946-1954, 1994
16. D'Argenio DZ, Schumitzky A: ADAPT II User's Guide. University of Southern California, Los Angeles, CA, Biomedical Simulations Resource, 1990
17. Lalonde RL: Pharmacodynamics, in Evans WE, Schentag JJ, Jusko WJ (eds): Applied Pharmacokinetics: Principles of Therapeutic Drug Monitoring (ed 3). Vancouver, WA, Applied Therapeutics, 1992, pp 4-1-4-33
18. Metzler CM, Weiner DL: PCNONLIN User's Guide (ed 4). Lexington, KY, Statistical Consultants, 1992
19. Bums HA III, Awada A, Kuhn JG, et al: Phase I and pharmacokinetic studies of topotecan administered as a 72 or 120 h continuous infusion. Anticancer Drugs 5:394-402, 1994
20. Hochster H, Liebes L, Speyer J, et al: Phase I trial of low-dose continuous topotecan infusion in patients with cancer: An active and well-tolerated regimen. J Clin Oncol 12:553-559, 1994
21. Haas NB, LaCreta FP, Walczak J, et al: Phase I/pharmacokinetic study of topotecan by 24-hour continuous infusion weekly. Cancer Res 54:1220-1226, 1994
22. Wall JG, Burns HA III, Von Hoff DD, et al: A phase I clinical and pharmacokinetic study of topoisomerase I inhibitor topotecan (SK&F 104864) given as an intravenous bolus every 21 days. Anticancer Drugs 3:337-345, 1992
23. Houghton PJ, Chesire PJ, Myers L, et al: Evaluation of 9-dimethylaminomethyl-10-hydroxycamptothecin against xenografts derived from adult and childhood solid tumors. Cancer Chemother Pharmacol 31:229-239, 1992
24. Bunin N, Rivera G, Goode F: Ocular relapse in the anterior chamber in childhood acute lymphoblastic leukemia. Cancer Chemother Pharmacol 5:299-303, 1987
25. Rosenthal AR: Ocular manifestations of leukemia. A review. Ophthalmalogy 90:899-905, 1983
26. Baker SD, Heideman RL, Crom WR, et al: Cerebrospinal pharmacokinetics and penetration of continuous infusion topotecan in children with central nervous system tumors. Cancer Chemother Pharmacol 37:195-202, 1995
27. Rapoport SI: Blood-brain barrier in physiology and medicine. New York, NY, Raven, 1976
28. Slevin ML, Clark PI, Joel SP, et al: A randomized trial to evaluate the effect of schedule on the activity of etoposide in small-cell lung cancer. J Clin Oncol 7:1333-1340, 1989