A phase II study of cloretazine (VNP40101M), a novel sulfonylhydrazine alkylating agent, in patients with very high risk relapsed acute myeloid leukemia

Leukemia Research

Volumn 30, Issue 12, 2006, Pages 1591-1595

  Giles, Francis ^a   Verstovsek, Srdan ^a   Faderl, Stefan ^a   Vey, Norbert ^b   Karp, Judy ^c   Roboz, Gail ^d   Khan, Khuda Dan ^e   Cooper, Maureen ^e   Bilgrami, Syed Fazl Ali ^f   Ferrant, Augustin ^g   Daenen, Simon ^h   Karsten, Verena ⁱ   Cahill, Ann ⁱ   Albitar, Maher ^j   Kantarjian, Hagop ^a   O'Brien, Susan ^a   Feldman, Eric ^d  

^a UNIVERSITY OF TEXAS   (United States)

^b INSTITUT PAOLI CALMETTES   (France)

^c JOHNS HOPKINS UNIVERSITY   (United States)

^d Department of Obstetrics Gynecology   (United States)

^e Hematology Oncology of Indiana PC   (United States)

^f SAINT FRANCIS HOSPITAL AND MEDICAL CENTER   (United States)

^g CLINIQUES UNIVERSITAIRES SAINT LUC   (Belgium)

^h UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

ⁱ Vion Pharmaceuticals Incorporated   (United States)

^j QUEST DIAGNOSTICS NICHOLS INSTITUTE   (United States)

more..

Author keywords

90CE; Alkylating; Relapsed AML; Sulfonylhydrazine; VNP40101M

Indexed keywords

ALKYLATING AGENT; ANTIHISTAMINIC AGENT; CLORETAZINE; HYDRAZINE DERIVATIVE; HYDROXYUREA; SULFONYLHYDRAZINE DERIVATIVE; UNCLASSIFIED DRUG;

ACUTE GRANULOCYTIC LEUKEMIA; ADULT; AGED; CANCER REGRESSION; CANCER SURVIVAL; CATHETER INFECTION; CLINICAL TRIAL; CONFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOGENETICS; DEPRESSION; DRUG INDUCED DISEASE; DRUG INDUCED HEADACHE; ERYTHEMA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FLUSHING; HEPATOBILIARY DISEASE; HUMAN; HYPOTENSION; HYPOXIA; KIDNEY FAILURE; LETTER; LUNG INFILTRATE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SINGLE DRUG DOSE; SURVIVAL RATE; SYNCOPE; THRUSH; TRANSAMINITIS;

ACUTE DISEASE; ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; COHORT STUDIES; FEMALE; HUMANS; HYDRAZINES; INFUSIONS, INTRAVENOUS; LEUKEMIA, MYELOID; MALE; MIDDLE AGED; RECURRENCE; REMISSION INDUCTION; RISK FACTORS; SULFONAMIDES; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 33750022018     PISSN: 01452126     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.leukres.2006.02.019     Document Type: Letter

References (21)

1. Giles F.J., Keating A., Goldstone A.H., Avivi I., Willman C.L., and Kantarjian H.M. Acute myeloid leukemia. Hematology (Am Soc Hematol Educ Program) (2002) 73-110
2. Shyam K., Cosby L.A., and Sartorelli A.C. Synthesis and evaluation of N,N'-bis(arylsulfonyl)hydrazines as antineoplastic agents. J Med Chem 28 (1985) 525-527
3. Shyam K., Furubayashi R., Hrubiec R.T., Cosby L.A., and Sartorelli A.C. 1,2-Bis(arylsulfonyl)hydrazines. 2. The influence of arylsulfonyl and aralkylsulfonyl substituents on antitumor and alkylating activity. J Med Chem 29 (1986) 1323-1325
4. Shyam K., Hrubiec R.T., Furubayashi R., Cosby L.A., and Sartorelli A.C. 1,2-Bis(sulfonyl)hydrazines. 3. Effects of structural modification on antineoplastic activity. J Med Chem 30 (1987) 2157-2161
5. Shyam K., Penketh P.G., Divo A.A., Loomis R.H., Rose W.C., and Sartorelli A.C. Synthesis and evaluation of 1-acyl-1,2-bis(methylsulfonyl)-2-(2-chloroethyl)hydrazines as antineoplastic agents. J Med Chem 36 (1993) 3496-3502
6. Shyam K., Penketh P.G., Loomis R.H., Rose W.C., and Sartorelli A.C. Antitumor 2-(aminocarbonyl)-1,2-bis(methylsulfonyl)-1-(2-chloroethyl)-hydrazines. J Med Chem 39 (1996) 796-801
7. Pratviel G., Shyam K., and Sartorelli A.C. Cytotoxic and DNA-damaging effects of 1,2-bis(sulfonyl)hydrazines on human cells of the Mer+ and Mer- phenotype. Cancer Biochem Biophys 10 (1989) 365-375
8. Penketh P.G., Shyam K., and Sartorelli A.C. Comparison of DNA lesions produced by tumor-inhibitory 1,2-bis(sulfonyl)hydrazines and chloroethylnitrosoureas. Biochem Pharmacol 59 (2000) 283-291
9. Finch R.A., Shyam K., Penketh P.G., and Sartorelli A.C. 1,2-Bis(methylsulfonyl)-1-(2-chloroethyl)-2-(methylamino)carbonylhydrazine (101M): a novel sulfonylhydrazine prodrug with broad-spectrum antineoplastic activity. Cancer Res 61 (2001) 3033-3038
10. Ishiguro K., Shyam K., Penketh P.G., and Sartorelli A.C. Role of O6-alkylguanine-DNA alkyltransferase in the cytotoxic activity of cloretazine. Mol Cancer Ther 4 (2005) 1755-1763
11. Briscoe W.T., and Duarte S.P. Preferential alkylation by 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU) of guanines with guanines as neighboring bases in DNA. Biochem Pharmacol 37 (1988) 1061-1066
12. Lown J.W., and McLaughlin L.W. Nitrosourea-induced DNA single-strand breaks. Biochem Pharmacol 28 (1979) 1631-1638
13. Mao J., Xu Y., Wu D., and Almassain B. Pharmacokinetics, mass balance, and tissue distribution of a novel DNA alkylating agent, VNP40101M, in rat. AAPS PharmSci 4 (2002) E24
14. Giles F., Thomas D., Garcia-Manero G., et al. A Phase I and pharmacokinetic study of VNP40101M, a novel sulfonylhydrazine alkylating agent, in patients with refractory leukemia. Clin Cancer Res 10 (2004) 2908-2917
15. Ferrara F., Palmieri S., and Mele G. Prognostic factors and therapeutic options for relapsed or refractory acute myeloid leukemia. Haematologica 89 (2004) 998-1008
16. Breems D.A., Van Putten W.L., Huijgens P.C., et al. Prognostic index for adult patients with acute myeloid leukemia in first relapse. J Clin Oncol 23 (2005) 1969-1978
17. Godder K., Eapen M., Laver J.H., et al. Autologous hematopoietic stem-cell transplantation for children with acute myeloid leukemia in first or second complete remission: a prognostic factor analysis. J Clin Oncol 22 (2004) 3798-3804
18. Giles F., O'Brien S., Cortes J., et al. Outcome of patients with acute myelogenous leukemia after second salvage therapy. Cancer 104 (2005) 547-554
19. Rowe J.M., Li X., Cassileth P.A., et al. Very poor survival of patients with AML who relapse after achieving a first complete remission: The Eastern Cooperative Oncology Group Experience. ASH Annual Meeting Abstracts 106 (2005) 546
20. Giles F., O'Brien S., Rizzieri D., et al. Cloretazine (VNP40101M) is active in elderly untreated poor risk patients with acute myelogenous leukemia or high risk myelodysplasia. ASH Annual Meeting Abstracts 106 (2005) 2786
21. Giles F., Rizzieri D., Karp J., et al. Use of a disease-specific comorbidity index to describe elderly patients with acute myelogenous leukemia and high risk myelodysplasia enrolled in a phase II study of cloretazine (VNP40101M). ASH Annual Meeting Abstracts 106 (2005) 2787