Phase I Clinical Trial and Pharmacokinetic Study of the Spicamycin Analog KRN5500 Administered as a 1-Hour Intravenous Infusion for Five Consecutive Days to Patients with Refractory Solid Tumors

Clinical Cancer Research

Volumn 9, Issue 14, 2003, Pages 5178-5186

  Supko, Jeffrey G ^a   Eder Jr , Joseph P ^b   Ryan, David P ^a   Seiden, Michael V ^a   Lynch, Thomas J ^a   Amrein, Phillip C ^a   Kufe, Donald W ^b   Clark, Jeffrey W ^a  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

6 [4 DEOXY 4 (2,4 TETRADECADIENOYLGLYCYLAMINO) GLYCERO BETA MANNOHEPTOPYRANOSYLAMINO] 9H PURINE; ANTINEOPLASTIC ANTIBIOTIC; PLACEBO; SPICAMYCIN;

ACUTE TOXICITY; ADULT; AGED; ALOPECIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; ATAXIA; BLOOD SAMPLING; CLINICAL ARTICLE; CLINICAL TRIAL; COLORECTAL CARCINOMA; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFECT; DYSPNEA; FATIGUE; FEMALE; HUMAN; HYPERBILIRUBINEMIA; HYPERGLYCEMIA; INTERSTITIAL PNEUMONIA; LIVER TOXICITY; LUNG TOXICITY; LYMPHOCYTOPENIA; MALE; MAXIMUM TOLERATED DOSE; NAUSEA; NEUROTOXICITY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; SOLID TUMOR; THROMBOCYTOPENIA; VOMITING;

ADULT; AGED; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; NEOPLASMS; PURINE NUCLEOSIDES; SALVAGE THERAPY;

EID: 0242525649     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (25)

1. Hayakawa, Y., Nakagawa, M., Kawai, H., Tanabe, K., Nakayama, H., Shimazu, A., Seto, H., and Otake, N. Studies on the differentiation inducers of myeloid leukemic cells. III. Spicamycin, a new inducer of differentiation of HL-60 human promyelocytic leukemia cells. J. Antibiot., 36: 934-937, 1983.
2. Hayakawa, Y., Nakagawa, M., Kawai, H., Tanabe, K., Nakayama, H., Shimazu, A., Seto, H., and Otake, N. Spicamycin, a new differentiation inducer of mouse myeloid leukemia cells (M1) and human promyelocytic leukemia cells (HL-60). Agric. Biol. Chem., 49: 2685-2691, 1985.
3. Kamishohara, M., Kawai, H., Odagawa, A., Isoe, T., Mochizuki, J., Uchida, T., Hayakawa, Y., Seto, H., Tsuruo, T., and Otake, N. Structure-antitumor activity relationship of semi-synthetic spicamycin analogues. J. Antibiot., 46: 1439-1446, 1993.
4. Lee, Y. S., Nishio, K., Ogesawara, H., Funayama, Y., Ohira, T., and Saijo, N. In vitro cytotoxicity of a novel antitumor antibiotic, spicamycin derivative, in human lung cancer cell lines. Cancer Res., 55: 1075-1079, 1995.
5. Burger, A. M., Kaur, G., Hollingshead, M., Fischer, R. T., Nagashima, K., Malspeis, L., Duncan, K. L. K., and Sausville, E. A. Antiproliferative activity in vitro and in vivo of the spicarhycin analogue KRN5500 with altered glycoprotein expression. Clin. Cancer Res., 3: 455-463, 1997.
6. Kawasaki, K., Murakami, T., Ita, M., Sasaki, K., and Furukawa, S. KRN5500, a novel antitumor agent, induces apoptosis or cell differentiation in HL-60 cells. Cytometry, 39: 211-216, 2000.
7. Stine, K. C., Warren, B. A., Saylors, R. L., and Becton, D. L. KRN5500 induces apoptosis (PCD) of myeloid leukemia cell lines and patient blasts. Leuk. Res., 24: 741-749, 2000.
8. Kamishohara, M., Kawai, H., Odagawa, A., Isoe, T., Mochizuki, J., Uchida, T., Hayakawa, Y., Seto, H., Tsuruo, T., and Otake, N. Antitumor activity of SPM VIII, a derivative of the nucleoside antibiotic spicamycin, against human tumor xenografts. J. Antibiot., 47: 1305-1311, 1994.
9. Kamishohara, M., Kawai, H., Sakai, T., Isoe, T., Hasegawa, K., Mochizuki, J., Uchida, T., Kataoka, S., Yamaki, H., and Tsuro, T. Antitumor activity of spicamycin derviative, KRN5500, and its active metabolite in tumor cells. Oncol. Res., 6: 383-390, 1994.
10. Kataoka, S., Kamishohara, M., Kawai, H., Isoe, T., Uchida, T., Mochizuki, J., Tsuruo, T., and Otake, N. Activation mechanism of spicamycin derivative KRN5500 in human tumor cells. Proc. Am. Assoc. Cancer Res., 36: 397, 1995.
11. Kamishohara, M., Kawai, H., Sakai, T., Uchida, T., Tsuruo, T., and Otake, N. Inhibitory effect of a spicamycin derivative, KRN5500, on the growth of hepatic metastasis of human colon cancer-producing tissue polypeptide antigen. Cancer Chemother. Pharmacol., 38: 495-498, 1996.
12. Kamishohara, M., Kenney, S., Domergue, R., Vistica, D. T., and Sausville, E. A. Selective accumulation of the endoplasmic reticulum-Golgi intermediate compartment induced by the antitumor drug KRN5500. Exp. Cell Res., 256: 468-479, 2000.
13. Benet, L. Z. General treatment of linear mammillary models with elimination from any compartment as used in pharmacokinetics. J. Pharm. Sci., 61: 536-541, 1972.
14. Eder, J. P., Jr., Supko, J. G., Lynch, T. Bryant, M., Vosburgh, E., Shulman, L. N., Xu, G., and Kufe, D. W. A Phase I trial of the colloidal dispersion formulation of 9-amino-20(S)-camptothecin administered as a 72 hour continuous intravenous infusion. Clin. Cancer Res., 4: 317-324, 1998.
15. Gabrielsson, J., Weiner, D. Pharmacokinetic/Pharmacodynamic Data Analysis: Concepts and Applications. Stockholm, Sweden: Swedish Pharmaceutical Press, 1994.
16. Mizuta, E., and Tsubotani, A. Preparation of mean drug concentration-time curves in plasma. A study on the frequency distribution of pharmacokinetic parameters. Chem. Pharm. Bull., 33: 1620-1632, 1985.
17. Miller, R. G. The jackknife: a review. Biometrika, 61: 1-15, 1974.
18. Lacey, L. F., Keene, O. N., Pritchard, J. F., and Bye, A. Common noncompartmental pharmacokinetic variables: are they normally or log-normally distributed? J. Biopharm. Stat., 7: 171-178, 1997.
19. Yoshioka, E., Morino, M., Tanaka, H., and Shinkai, H. Manual and automatic extraction and high-performance liquid chromatographic determination of a spicamycin derivative, KRN5500, in rat plasma. J. Chromatogr. B, 691: 371-375, 1997.
20. Shah, V. P., Midha, K. K., Dighe, S., McGilveray, I. J., Skelly, J. P., Yacobi, A., Layloff, T., Viswanathan, C. T., Cook, C. E., McDowall, R. D., Pittman, K. A., and Spector, S. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. J. Pharm. Sci., 81: 309-312, 1992.
21. Takama, H., Tanaka, H., Sudo, T., Tamura, T., and Tanigawara, Y. Population pharmacokinetic modeling and model validation of a spicamycin derivative, KRN5500, in Phase 1 study. Cancer Chemother. Pharmacol., 47: 404-410, 2001.
22. Hutchins, L. F., Unger, J. M., Crowley, J. J., Coltman, C. A., Jr., and Albain, K. S. Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N. Engl. J. Med., 341: 2061-2067, 1999.
23. Baker, S. D., and Grochow, L. B. Pharmacology of cancer chemotherapy in the older person. Clin. Geriatr. Med., 13: 169-183, 1997.
24. Lichtman, S. M., and Skirvan, J. A. Pharmacology of antineoplastic agents in older cancer patients. Oncology (Basel), 14: 1743-1755, 2000.
25. Durnas, C., Loi, C., and Cusack, B. J. Hepatic drug metabolism and aging. Clin. Pharmacokinet., 19: 359-389, 1990.