A phase I dose-finding and pharmacokinetic study of subcutaneous semisynthetic homoharringtonine (ssHHT) in patients with advanced acute myeloid leukaemia

British Journal of Cancer

Volumn 95, Issue 3, 2006, Pages 253-259

  Levy V ^a,b   Zohar, S ^a,b   Bardin, C ^c   Vekhoff, A ^c   Chaoui, D ^c   Rio, B ^c   Legrand, O ^c   Sentenac, S ^c   Rousselot, P ^b   Raffoux, E ^b   Chast, F ^c   Chevret, S ^a,b   Marie, J P ^c  

^a ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

^b SAINT LOUIS HOSPITAL   (France)

^c HÔTEL DIEU   (France)

Author keywords

Continual reassessment method; Homoharringtonine; Leukaemia; Phase I; Stopping rules

Indexed keywords

HOMOHARRINGTONINE;

ACUTE GRANULOCYTIC LEUKEMIA; ADULT; ADVANCED CANCER; AGED; ANASARCA; ANTINEOPLASTIC ACTIVITY; ARTICLE; BAYES THEOREM; BLOOD TOXICITY; BONE MARROW SUPPRESSION; CANCER REGRESSION; CANDIDIASIS; CARDIOVASCULAR DISEASE; CHRONIC DISEASE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTINUAL REASSESSMENT METHOD; DIABETES MELLITUS; DOSE CALCULATION; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE REGIMEN; DRUG HALF LIFE; DRUG METABOLISM; ENDOCRINE DISEASE; FEBRILE NEUTROPENIA; FEMALE; GASTROINTESTINAL TOXICITY; HEMATEMESIS; HUMAN; HYPERGLYCEMIA; HYPEROSMOLAR COMA; INFECTION; LUNG ASPERGILLOSIS; MALE; MAXIMUM TOLERATED DOSE; METHODOLOGY; MUSCLE DISEASE; NEUROLOGIC DISEASE; PAIN; PANCYTOPENIA; PHASE 1 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RASH; SEPTICEMIA; SKIN PAIN; SKIN TOXICITY;

ACUTE DISEASE; ADULT; AGED; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HARRINGTONINES; HUMANS; INJECTIONS, SUBCUTANEOUS; LEUKEMIA, MYELOID; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; REMISSION INDUCTION; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 33746883844     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6603265     Document Type: Article

References (37)

1. Baguley BC, Calveley SB, Crowe KK, Fray LM, O'Rourke SA, Smith GP (1989) Comparison of the effects of flavone acetic acid, fostriecin, homoharringtonine and tumour necrosis factor alpha on colon 38 tumours in mice. Eur J Cancer Clin Oncol 25: 263-269
2. Bennett JM, Young ML, Andersen JW, Cassileth PA, Tallman MS, Paietta E, Wiernik PH, Rowe JM (1997) Long-term survival in acute myeloid leukemia: the Eastern Cooperative Oncology Group experience. Cancer 80: 2205-2209
3. Buchner T, Hiddemann W, Schoch C, Haferlach T, Sauerland MC, Heinecke A (2001) Acute myeloid leukaemia (AML): treatment of the older patient. Best Pract Res Clin Haematol 14: 139-151
4. Cai Z, Lin M, Wuchter C, Ruppert V, Dorken B, Ludwig WD, Karawajew L (2001) Apoptotic response to homoharringtonine in human wt p53 leukemic cells is independent of reactive oxygen species generation and implicates Bax translocation, mitochondrial cytochrome c release and caspase activation. Leukemia 15: 567-574
5. Cheson BD, Cassileth PA, Head DR, Schiffer CA, Bennett JM, Bloomfield CD, Brunning R, Gale RP, Grever MR, Keating MJ, Sawitsky A, Stass S, Weinstein H, Woods WG (1990) Report of the National Cancer Institute-sponsored workshop on definitions of diagnosis and response in acute myeloid leukemia. J Clin Oncol 8: 813-819
6. Coonley CJ, Warrell Jr RP, Young CW (1983) Phase I trial of homoharringtonine administered as a 5-day continuous infusion. Cancer Treat Rep 67: 693-696
7. Feldman E, Arlin Z, Ahmed T, Mittelman A, Puccio C, Chun H, Cook P, Baskind P (1992a) Homoharringtonine in combination with cytarabine for patients with acute myelogenous leukemia. Leukemia 6: 1189-1191
8. Feldman E, Arlin Z, Ahmed T, Mittelman A, Puccio C, Chun H, Cook P, Baskind P (1992b) Homoharringtonine is safe and effective for patients with acute myelogenous leukemia. Leukemia 6: 1185-1188
9. Fresno M, Jimenez A, Vazquez D (1977) Inhibition of translation in eukaryotic systems by homoharringtonine. Eur J Biochem 72: 323-330
10. Garrett-Mayer E (2006) The continual reassessment method for dose-finding studies: a tutorial. Clin Trials 3: 57-71
11. Grem JL, Cheson BD, King SA, Leyland-Jones B, Suffness M (1988) Cephalotaxine esters: antileukemic advance or therapeutic failure? J Natl Cancer Inst 80: 1095-1103
12. Huang CC, Han CS, Yue XF, Shen CM, Wang SW, Wu FG, Xu B (1983) Cytotoxicity and sister chromatid exchanges induced in vitro by six anticancer drugs developed in the People's Republic of China. J Natl Cancer Inst 71: 841-847
13. Huang MT (1975) Harringtonine, an inhibitor of initiation of protein biosynthesis. Mol Pharmacol 11: 511-519
14. Kantarjian HM, Keating MJ, Walters RS, Koller CA, McCredie KB, Freireich EJ (1989) Phase II study of low-dose continuous infusion homoharringtonine in refractory acute myelogenous leukemia. Cancer 63: 813-817
15. Kantarjian HM, Talpaz M, O'Brien S, Kurzrock R, Gutterman J, Keating MJ, McCredie KB, Freireich EJ (1997) Chronic myelogenous leukemia - progress at the MD Anderson Cancer Center over the past two decades and future directions: first Emil J Freireich Award Lecture. Clin Cancer Res 3: 2723-2733
16. Kantarjian HM, Talpaz M, Santini V, Murgo A, Cheson B, O'Brien SM (2001) Homoharringtonine: history, current research, and future direction. Cancer 92: 1591-1605
17. Kuliczkowski K (1989) Influence of harringtonine on human leukemia cell differentiation. Arch Immunol Ther Exp (Warsz) 37: 69-76
18. Legha SS, Keating M, Picket S, Ajani JA, Ewer M, Bodey GP (1984) Phase I clinical investigation of homoharringtonine. Cancer Treat Rep 68: 1085-1091
19. Marin D, Kaeda JS, Andreasson C, Saunders SM, Bua M, Olavarria E, Goldman JM, Apperley JF (2005) Phase I/II trial of adding semisynthetic homoharringtonine in chronic myeloid leukemia patients who have achieved partial or complete cytogenetic response on imatinib. Cancer 103: 1850-1855
20. Neidhart JA, Young DC, Derocher D, Metz EN (1983) Phase I trial of homoharringtonine. Cancer Treat Rep 67: 801-804
21. Neidhart JA, Young DC, Kraut E, Howinstein B, Metz EN (1986) Phase I trial of homoharringtonine administered by prolonged continuous infusion. Cancer Res 46: 967-969
22. O'Brien S, Giles F, Talpaz M, Cortes J, Rios MB, Shan J, Thomas D, Andreeff M, Kornblau S, Faderl S, Garcia-Manero G, White K, Mallard S, Freireich E, Kantarjian HM (2003) Results of triple therapy with interferon-alpha, cytarabine, and homoharringtonine, and the impact of adding imatinib to the treatment sequence in patients with Philadelphia chromosome-positive chronic myelogenous leukemia in early chronic phase. Cancer 98: 888-893
23. O'Brien S, Kantarjian H, Beran M, Smith T, Koller C, Estey E, Robertson LE, Lerner S, Keating M (1993) Results of fludarabine and prednisone therapy in 264 patients with chronic lymphocytic leukemia with multivariate analysis-derived prognostic model for response to treatment. Blood 82: 1695-1700
24. O'Quigley J, Pepe M, Fisher L (1990) Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics 46: 33-48
25. O'Quigley J, Zohar S (2006) Experimental designs for phase I and phase I/II dose-finding studies. Br J Cancer 94: 609-613
26. Savaraj N, Lu K, Dimery I, Feun LG, Burgess M, Keating M, Loo TL (1986) Clinical pharmacology of homoharringtonine. Cancer Treat Rep 70: 1403-1407
27. Stewart JA, Krakoff IH (1985) Homoharringtonine: a phase I evaluation. Invest New Drugs 3: 279-286
28. Takemura Y, Ohnuma T, Chou TC, Okano T, Holland JF (1985) Biologic and pharmacologic effects of harringtonine on human leukemia-lymphoma cells. Cancer Chemother Pharmacol 14: 206-210
29. Tujebajeva RM, Graifer DM, Karpova GG, Ajtkhozhina NA (1989) Alkaloid homoharringtoninie inhibits polypeptide chain elongation in human ribosomes on the step of peptide bond formation. FEBS Lett 257: 254-256
30. Visani G, Russo D, Ottaviani E, Tosi P, Damiani D, Michelutti A, Manfroi S, Baccarani M, Tura S (1997) Effects of homoharringtonine alone and in combination with alpha interferon and cytosine arabinoside on 'in vitro' growth and induction of apoptosis in chronic myeloid leukemia and normal hematopoietic progenitors. Leukemia 11: 624-628
31. Warrell Jr RP, Coonley CJ, Gee TS (1985) Homoharringtonine: an effective new drug for remission induction in refractory nonlymphoblastic leukemia. J Clin Oncol 3: 617-621
32. Wilkoff LJ, Dulmadge DA, Laster Jr WR, Griswold Jr DP (1989) Effect of homoharringtonine on the viability of murine leukemia P388 cells resistant to either adriamycin, vincristine, or 1-beta-D-arabinofuranosylcytosine. Cancer Chemother Pharmacol 23: 145-150
33. Ye XJ, Lin MF (2004) Homoharringtonine induces apoptosis of endothelium and down-regulates VEGF expression of K562 cells. J Zhejiang Univ Sci 5: 230-234
34. Zhou DC, Zittoun R, Marie JP (1995) Homoharringtonine: an effective new natural product in cancer chemotherapy. Bull Cancer 82: 987-995
35. Zhou JY, Chen DL, Shen ZS, Koeffler HP (1990) Effect of homoharringtonine on proliferation and differentiation of human leukemic cells in vitro. Cancer Res 50: 2031-2035
36. Zohar S, Chevret S (2001) The continual reassessment method: comparison of Bayesian stopping rules for dose-ranging studies. Stat Med 20: 2827-2843
37. Zohar S, Latouche A, Taconnet M, Chevret S (2003) Software to compute and conduct sequential Bayesian phase I or II dose-ranging clinical trials with stopping rules. Comput Methods Programs Biomed 72: 117-125