A Phase I Dose-Escalation and Pharmacokinetic Study of Brostallicin (PNU-166196A), A Novel DNA Minor Groove Binder, in Adult Patients with Advanced Solid Tumors

Clinical Cancer Research

Volumn 10, Issue 2, 2004, Pages 468-475

  Lockhart, A Craig ^a   Howard, Martin ^c   Hande, Kenneth R ^a   Roth, Bruce J ^a   Berlin, Jordan D ^a   Vreeland, Franzanne ^b   Campbell, Angela ^b   Fontana, Erminia ^c   Fiorentini, Francesca ^c   Fowst, Camilla ^c   Paty, Victoria A ^a   Lankford, Odessa ^a   Rothenberg, Mace L ^a,d  

^a VANDERBILT INGRAM CANCER CENTER   (United States)

^b PFIZER INC   (United States)

^c Pharmacia Corporation   (Italy)

^d Division of Hematology   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BROSTALLICIN; DISTAMYCIN A; DISTAMYCIN A DERIVATIVE; DNA MINOR GROOVE BINDING AGENT; NEW DRUG; TALLIMUSTINE; UNCLASSIFIED DRUG;

ADULT; ADVANCED CANCER; ADVANCED SOLID TUMOR; AGED; ANEMIA; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; BACKACHE; BLEEDING; BONE MARROW SUPPRESSION; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL TRIAL; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG HALF LIFE; DRUG RESPONSE; DRUG STRUCTURE; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPONATREMIA; MALE; MAXIMUM TOLERATED DOSE; NEUTROPENIA; OPEN STUDY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SOLID TUMOR; THORAX PAIN; THROMBOCYTOPENIA;

AGED; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; CALIBRATION; DNA DAMAGE; FEMALE; GUANIDINES; HUMANS; KINETICS; MALE; MIDDLE AGED; MODELS, CHEMICAL; NEOPLASMS; PYRROLES; TIME FACTORS;

EID: 10744232650     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-0658-03     Document Type: Article

References (29)

1. Marchini, S., Broggini, M., Sessa, C., and D'Incalci, M. Development of distamycin-related DNA binding anticancer drugs. Exp. Opin. Investig. Drugs, 10: 1703-1714, 2001.
2. Wyatt, M. D., Lee, M., Garbiras, B. J., Souhami, R. L., and Hartley, J. A. Sequence specificity of alkylation for a series of nitrogen mustard-containing analogues of distamycin of increasing binding site size: evidence for increased cytotoxicity with enhanced sequence specificity. Biochemistry, 34: 13034-13041, 1995.
3. Woynarowski, J. M., Napier, C., Trevino, A. V., and Arnett, B. Region-specific DNA damage by AT-specific DNA-reactive drugs is predicted by drug binding specificity. Biochemistry, 39: 9917-9927, 2000.
4. Woynarowski, J. M., Trevino, A. V., Rodriguez, K. A., Hardies, S. C., and Benham, C. J. AT-rich islands in genomic DNA as a novel target for AT-specific DNA-reactive antitumor drugs, J. Biol. Chem., 276: 40555-40566, 2001.
5. Arcamone, F., Penco, S., Orezzi, P. G., Nicolella, V., and Pirella, A. Structure and synthesis of distamycin A. Nature (Lond.), 203: 1064-1065, 1964.
6. Cozzi, P. A new class of cytotoxic DNA minor groove binders: α-halogenoacrylic derivatives of pyrrolecarbamoyl oligomers. Farmaco., 56: 57-65, 2001.
7. Broggini, M., Erba, E., Ponti, M., Ballinari, D., Geroni, C., Spreafico, F., and D'Incalci, M. Selective DNA interaction of the novel distamycin derivative FCE 24517. Cancer Res., 51: 199-204, 1991.
8. Weiss, G. R., Poggesi, I., Rocchetti, M., DeMaria. D., Mooneyham, T., Reilly, D., Vitek, L. V., Whaley, F., Patricia, E., Von Hoff, D. D., and O'Dwyer, P. A phase I and pharmacokinetic study of tallimustine [PNU 152241 (FCE 24517)] in patients with advanced cancer. Clin. Cancer Res., 4: 53-59, 1998.
9. Sessa, C., Pagani, O., Zurlo, M. G., de Jong, J., Hofmann, C., Lassus, M., Marrari, P., Strolin Benedetti, M., and Cavalli, F. Phase I study of the novel distamycin derivative tallimustine (FCE 24517). Ann. Oncol., 5: 901-907, 1994.
10. Cozzi, P., Beria, I., Caldarelli, M., Capolongo, L., Geroni, C., and Mongelli, N. Cytotoxic halogenoacrylic derivatives of distamycin A. Bioorg. Med. Chem. Lett., 10: 1269-1272, 2000.
11. Ghielmini, M., Bosshard, G., Capolongo, L., Geroni, M. C., Pesenti, E., Torri, V., D'Incalci, M., Cavalli, F., and Sessa, C. Estimation of the haematological toxicity of minor groove alkylators using tests on human cord blood cells. Br. J. Cancer, 75: 878-883, 1997.
12. Ciarrocchi, G., Fontana, M., Spadari, S., and Montecucco, A. Inhibition of human DNA ligase by anthracyclines and distamycins. Anticancer Res., 11: 1317-1322, 1991.
13. Fontana, M., Lestingi, M., Mondello, C., Braghetti, A., Montecucco, A., and Ciarrocchi, G. DNA binding properties of FCE24517, an electrophilic distamycin analogue. Anti-Cancer Drug Design, 7: 131-141, 1992.
14. Rossi, R., Montecucco, A., Capolongo, L., Mezzina, M., Chevallier-Lagente, O., Sarasin, A., and Ciarrocchi, G. The alkylating antitumor drug tallimustine does not induce DNA repair. Anticancer Res., 16: 3779-3783, 1996.
15. Cozzi, P., Beria, I., Caldarelli, M., Geroni, C., Mongelli, N., and Pennella, G. Cytotoxic α-bromoacrylic derivatives of distamycin analogues modified at the amidino moiety. Bioorg. Med. Chem. Lett., 10: 1273-1276, 2000.
16. Geroni, C., Pennella, G., Capolongo, L., Moneta, D., Rossi, R., Farao, M., Marchini, S., and Cozzi, P. Antitumor activity of PNU-166196, a novel DNA minor groove binder selected for clinical development., Proc. Am. Assoc. Cancer Res., 41: 265, 2000.
17. Schecter, R. L., Alaoui-Jamali, M. A., and Batist, G. Glutathione S-transferase in chemotherapy resistance and in carcinogenesis. Biochem. Cell Biol., 70: 349-353, 1992.
18. Shen, H., Kauvar, L., and Tew, K. D. Importance of glutathione and associated enzymes in drug response. Oncol. Res., 9: 295-302, 1997.
19. Tsuchida, S., and Sato, K. Glutathione transferases and cancer. Crit. Rev. Biochem. Mol. Biol., 27: 337-384, 1992.
20. Geroni, C., Marchini, S., Cozzi, P., Galliera, E., Ragg, E., Colombo, T., Battaglia, R., Howard, M., D'Incalci, M., and Broggini, M. Brostallicin, a novel anticancer agent whose activity is enhanced upon binding to glutathione. Cancer Res., 62: 2332-2336, 2002.
21. Bader, P., Fuchs, J., Wenderoth, M., von Schweinitz, D., Niethammer, D., and Beck, J. F. Altered expression of resistance associated genes in hepatoblastoma xenografts incorporated into mice following treatment with adriamycin or cisplatin. Anticancer Res., 18: 3127-3132, 1998.
22. Cazenave, L. A., Moscow, J. A., Myers, C. E., and Cowan, K. H. Glutathione S-transferase and drug resistance. Cancer Treat. Res., 48: 171-187, 1989.
23. Colella, G., Marchini, S., D'Incalci, M., Brown, R., and Broggini, M. Mismatch repair deficiency is associated with resistance to DNA minor groove alkylating agents, Br. J. Cancer, 80: 338-343, 1999.
24. Arbuck, S. G., Ivy, S. P., and Setser, A. The Revised Common Toxicity Criteria: Version 2.0: The National Cancer Institute, 1998.
25. Simon, R., Freidlin, B., Rubinstein, L., Arbuck, S. G., Collins, J., and Christian, M. C. Accelerated titration designs for phase I clinical trials in oncology. J. Natl. Cancer Inst., 89: 1138-1147, 1997.
26. Hammond, L. A., Eckardt, J. R., Baker, S. D., Eckhardt, S. G., Dugan, M., Forral, K., Reidenberg, P., Statkevich, P., Weiss, G. R., Rinaldi, D. A., Von Hoff, D. D., and Rowinsky, E. K. Phase I and pharmacokinetic study of temozolomide on a daily-for-5-days schedule in patients with advanced solid malignancies. J. Clin. Oncol., 17: 2604-2613, 1999.
27. Cain, D., Hutson, S. M., and Wallin, R. Assembly of the warfarin-sensitive vitamin K 2, 3-epoxide reductase enzyme complex in the endoplasmic reticulum membrane, J. Biol. Chem., 272: 29068-75, 1997.
28. Henderson, C. J., Wolf, C. R., Kitteringham, N., Powell, H., Otto, D., and Park, B. K. Increased resistance to acetaminophen hepatotoxicity in mice lacking glutathione S-transferase Pi. Proc. Nat. Acad. Sci. USA, 97: 12741-12745, 2000.
29. Ten Tije, A. J., Verweij, J., Sparreboom, A., Van Der Gaast, A., Fowst, C., Fiorentini, F., Tursi, J., Antonellini, A., Mantel, M., Hartman, C. M., Stoter, G., Planting, A. S., and De Jonge, M. J. Phase I and pharmacokinetic study of brostallicin (PNU-166196), a new DNA minor-groove binder, administered intravenously every 3 weeks to adult patients with metastatic cancer. Clin. Cancer Res., 9: 2957-2964, 2003.