Phase I trial of dolastatin-10 (NSC 376128) in patients with advanced solid tumors

Clinical Cancer Research

Volumn 5, Issue 3, 1999, Pages 525-531

  Pitot, Henry C ^a   McElroy Jr , Edwin A ^a   Reid, Joel M ^a   Windebank, Anthony J ^a   Sloan, Jeff A ^a   Erlichman, Charles ^a   Bagniewski, Pamela G ^a   Walker, Denise L ^a   Rubin, Joseph ^a   Goldberg, Richard M ^a   Adjei, Alex A ^a   Ames, Matthew M ^a  

^a MAYO CLINIC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DOLASTATIN 10;

ADULT; ADVANCED CANCER; AGED; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CANCER CHEMOTHERAPY; CANCER INHIBITION; CLINICAL ARTICLE; CLINICAL TRIAL; DOSE RESPONSE; DRUG DISTRIBUTION; DRUG SAFETY; DRUG TOLERANCE; FEMALE; FOLLOW UP; GRANULOCYTOPENIA; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MALE; MOLLUSC; NEUROTOXICITY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SOLID TUMOR;

ADULT; AGED; AGRANULOCYTOSIS; AMYLOID NEUROPATHIES; ANTINEOPLASTIC AGENTS; DIARRHEA; FEMALE; HUMANS; INJECTIONS, INTRAVENOUS; MALE; MIDDLE AGED; NEOPLASMS; OLIGOPEPTIDES;

EID: 0033002547     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (26)

1. Pettit, G. R., Kamano, Y., Herald, C. L., Tuinman, A. A., Boettner, F. E., Kizu, H., Schmidt, J. M., Baczynskyj, L., Tomer, K. B., and Bontems, R. J. The isolation and structure of a remarkable marine animal antineoplastic constituent: dolastatin 10. J. Am. Chem. Soc., 109: 6883-6885, 1987.
2. Bai, R. L., Pettit, G. R., and Hamel, E. Binding of dolastatin-10 to tubulin at a distinct site for peptide antimitotic agents near the exchangeable nucleotide and Vinca alkaloid sites. J. Biol. Chem., 265: 17141-17149, 1990.
3. Bai, R., Roach, M. C., Jayaram, S. K., Barkoczy, J., Pettit, G. R., Luduena, R. F., and Hamel, E. Differential effects of active isomers, segments, and analogs of dolastatin-10 on ligand interactions with tubulin. Correlation with cytotoxicity. Biochem. Pharmacol., 45: 1503-1515, 1993.
4. Bai, R., Pettit, G. R., and Hamel, E. Dolastatin 10, a powerful cytostatic peptide derived from a marine animal. Biochem. Pharmacol., 39: 1941-1949, 1990.
5. Beckwith, M., Urba, W. J., and Longo, D. L. Growth inhibition of human lymphoma cell lines by the marine products, dolastatins 10 and 15. J. Natl. Cancer Inst. (Bethesda), 85: 483-488, 1993.
6. Maki, A., Mohammad, R., Razza, S., Saleh, M., Govindaraju, K. D., Pettit, G. R., and al-Katib, A. Effect of dolastatin 10 on human non-Hodgkin's lymphoma cell lines. Anti-Cancer Drugs, 7: 344-350, 1996.
7. Hu, Z. B., Gignac, S. M., Quentmeier, H., Pettit, G. R., and Drexler, H. G. Effects of dolastatins on human B-lymphocytic leukemia cell lines. Leuk. Res., 17: 333-339, 1993.
8. Waud, W. R., Dykes, D. J., Pettit, G. R., and Plowman, J. Preclinical antitumor activity of dolastatin-10. Proc. Amer. Assoc. Cancer Res., 34: 383, 1993.
9. Newman, R. A., Fuentes, A., Covey, J. M., and Benvenuto, J. A. Preclinical pharmacology of the natural marine product dolastatin-10 (NSC 376128). Drug Metab. Dispos., 22: 428-432, 1994.
10. Windebank, A. J., Smith, A. G., and Russell, J. W. The effect of nerve growth factor, ciliary neurotrophic factor, and ACTH analogs on cisplatin neurotoxicity in vitro. Neurology, 44: 488-494, 1994.
11. Russell, J. W., Windebank, A. J., and Podratz, J. L. Role of nerve growth factor in suramin neurotoxicity studied in vitro. Ann. Neurol., 36: 221-228, 1994.
12. Blexrud, M. D., and Windebank, A. J. A tissue culture model for screening neurotoxicity of therapeutic drugs. Ann. Neurol., 30: 300, 1991.
13. Schumacher, C. P., and Windebank, A. J. Potential neurotoxicity of dolastatin-10: a new chemotherapeutic agent. Ann. Neurol., 38: 316, 1995.
14. Dyck, P. J., Kratz, K. M., Lehman, K. A., Karnes, J. L., Melton, L. J., O'Brien, P. C., Litchy, W. J., Windebank, A. J., Smith, B. E., and Low, P. A. The Rochester diabetic neuropathy study: design, criteria for types of neuropathy, selection bias, and reproducibility of neuropathic tests. Neurology, 41: 799-807, 1991.
15. Dyck, P. J., Karnes, J. L., O'Brien, P. C., and Zimmerman, I. R. Detection thresholds of cutaneous sensation in humans. In: P. J. Dyck, P. K. Thomas, J. W. Griffin, P. A. Low, and J. F. Poduslo (eds.), Peripheral Neuropathy, Ed. 3, pp. 706-728. Philadelphia: W. B. Saunders Co., 1993.
16. Shapiro, S. S., and Wilk, M. B. An analysis of variance test for normality. Biometrika, 52: 591-610, 1965.
17. Lee, E. T. Statistical Methods for Survival Analysis, Ed. 2, pp. 66-92. New York: John Wiley & Sons, 1992.
18. Pepe, M. S., and Fleming, T. R. Weighted Kaplan-Meier statistics. Large sample and optimality considerations. J. R. Stat. Soc. B, 53: 341-352, 1991.
19. Mross, K., Herbst, K., Berdel, W., von Broen, I. M., and Hossfeld, D. K. Phase I and pharmacokinetic study with a cytotoxic peptide LU-103793 administered as an i.v. bolus injection. Ann. Oncol., 7 (Suppl. 1); 100, 1996.
20. Villalona-Cajero, M., Von Hoff, D., Eckhardt, G., Aylesworth, C., Hammond, L., Drengler, R., Razvillas, B., Kraynak, M., Jakimowicz, K., Fram, R., Velagapudi, R., and Rowinsky, E. Phase I and pharmacokinetic (PK) study of LU 103793, a water soluble analog of dolastatin-15, on a daily × 5 schedule. Proc. Am. Soc. Oncol., 16: 223a, 1997.
21. Wolff, I., Bruntsch, U., Cavalli, F., de Jong, J., von Broen, I. M., and Sessa, C. Phase I clinical study of LU 103793 (cemadotin) given on a weekly (wkly) × 4 schedule. Proc. Am. Soc. Oncol., 16: 223a, 1997.
22. Macdonald, D. R. Neurologic complications of chemotherapy. Neurol. Clin., 9: 955-967, 1991.
23. Windebank, A. J. Drug-induced neuropathies. In: H. P. Hartung (ed.), Bailliere's Clinical Neurology. International Practice and Research. Peripheral Neuropathies: Part I, Vol. 4, pp. 529-573. London: Baillere Tindall, 1995.
24. Windebank, K. A., Podratz, J. L., and Windebank, A. J. An in vitro model system for predicting neurotoxicity of new chemotherapeutic agents. Ann. Neurol., 40: 491, 1996.
25. Aherne, G. W., Hardcastle, A., Valenti, M., Bryant, A., Rogers, P., Pettit, G. R., Srirangam, J. K., and Kelland, L. R. Antitumor evaluation of dolastatins-10 and 15 and their measurement in plasma by radioimmunoassay. Cancer Chemother. Pharmacol., 38: 225-232, 1996.
26. Tran, H. T., Newman, R. A., Beck, D. E., Huie, R., Abbruzzese, J. L., and Madden, T. A Phase I, pharmacokinetic/pharmaco-dynamic study of dolastatin-10 in adult patients with advanced solid tumors. Proc. Am. Assoc. Cancer Res., 38: 306, 1997.