A phase I and pharmacological study of the glutamine antagonist acivicin with the amino acid solution aminosyn in patients with advanced solid malignancies

Clinical Cancer Research

Volumn 4, Issue 11, 1998, Pages 2763-2770

  Hidalgo, Manuel ^a   Rodriguez, Gladys ^a   Kuhn, John G ^a   Brown, Thomas ^a   Weiss, Geoffrey ^a   MacGovren, J Patrick ^a,b   Von Hoff, Daniel D ^a   Rowinsky, Eric K ^a  

^a CTRC Institute for Drug Development   (United States)

^b PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACIVICIN; AMINOSYN; GLUTAMINE DERIVATIVE;

ADULT; AGED; ANTINEOPLASTIC ACTIVITY; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONFUSION; CONTINUOUS INFUSION; CONTROLLED STUDY; DRUG BLOOD LEVEL; FEMALE; FEVER; FOLLOW UP; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; LETHARGY; MALE; MAXIMUM PERMISSIBLE DOSE; MENTAL HEALTH; NEUROTOXICITY; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SOLID TUMOR; THROMBOCYTOPENIA;

ADULT; AGED; AMINO ACIDS; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CENTRAL NERVOUS SYSTEM; FEMALE; GLUTAMINE; HUMANS; ISOXAZOLES; MALE; MIDDLE AGED; NEOPLASMS; THROMBOCYTOPENIA; TREATMENT OUTCOME;

EID: 0031757391     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (21)

1. Hanka, L. J., and Dietz, A. U-42126, a new antimetabolite antibiotic. Production, biological activity, and taxonomy of the producing microorganism. Antimicrob. Agents Chemother., 3: 425-431, 1973.
2. Cooney, D. A., Jayaram, H. N., Ryan, J. A., and Bono, V. H. Inhibition of L-asparagine synthetase by a new amino acid antibiotic with antitumor activity: L-(αS,5S)-α-amino-3-chloro-4,5-dihydro-5-isoxazoleacetic acid (NSC-163501). Cancer Chemother. Rep., 58: 793-802, 1974.
3. O'Dwyer, P. J., Alonso, M. T., and Leyland-Jones, B. Acivicin. A new glutamine antagonist in clinical trials. J. Clin. Oncol., 9: 1064-1071, 1984.
4. Houchens D. P., Ovejera A. A., Sheridan M. A., Johnson, R. K., Bogden, A. E., and Neil, G. L. Therapy for mouse and human tumor xenografts with the antitumor antibiotic AT-125. Cancer Treat. Rep., 63: 473-476, 1979.
5. Weiss, G. R., McGovren, J. P., Schade, D., and Kufe, D. W. Phase I and pharmacological study of acivicin by 24-hour continuous infusion. Cancer Res., 42: 3892-3895, 1982.
6. Earhart, R. H., Koeller, J. M., Davis, T. E., Borden, E. C., McGovren, J. P., David, H. L., and Tormey, D. C. Phase I trial and pharmacokinetics of acivicin administered by 72-hour infusion. Cancer Treat. Rep., 67: 683-692, 1983.
7. Taylor, S., Belt, R. J., Joseph, U., Haas, C. D., and Hoogstaraten, B. Phase I evaluation of AT-125 single dose every three weeks. Invest. New Drags, 2: 311-314, 1984.
8. Murphy, W. K., Burges, M. A., Valdevieso, M., and Bodey, G. P. Phase I evaluation of acivicin (AT-125). Proc. Am. Soc. Clin. Oncol., 23: 23, 1982.
9. Sridhar, K. S., Ohnuma, T., Chahinian, A. P., and Holland, J. F. Phase I study of acivicin in patients with advanced cancer. Cancer Treat. Rep., 67: 701-703, 1983.
10. McGovren, J. P., Neil G. L., Sem, P. C. C., and Stewart, J. C. Sex-and age-related mouse toxicity and disposition of the aminoacid antitumor agent, acivicin. J. Pharmacol. Exp. Ther., 216: 433-440, 1981.
11. McGovren, J. P., Stewart, J. C., Elfring, G. L., Smith, R. B., Soares, N., Wood, J. H., Poplack, D. G., and Von Hoff D. D. Plasma and cerebrospinal fluid pharmacokinetics of acivicin in Omaya reservoir-bearing rhesus monkeys. Cancer Treat. Rep., 66: 1333-1341, 1982.
12. Allen, L. M., and Yunis, A. A. Cellular transport of the glutamine analog acivicin does not require γ-glutamyl transpeptidase. IRCS Med. Sci., 11: 125-126, 1983.
13. James, J. H., and Fisher, J. E. Transport of neutral amino acids at the blood-brain barrier. Pharmacology, 22: 1-7, 1981.
14. Willians, M. G., Earhart, R. H., Bailey, H., and McGovren, J. P. Prevention of central nervous system toxicity of the antitumor antibiotic acivicin by concomitant infusion of an aminoacid mixture. Cancer Res., 50: 5475-5480, 1990.
15. Division of Cancer Treatment, National Cancer Institute. Guidelines for Reporting of Adverse Drug Reactions. Bethesda, MD: National Cancer Institute, 1988.
16. Folstein, M. F., Folstein, S. E., and McHugh, P. R. "Mini-mental state." A practical method for grading the cognitive state of patients for the clinician. J. Psychiatr. Res., 12: 189-198, 1975.
17. McGovren, J. P., Pratt, E. A., Belt, R. J., Taylor, S. A., Benjamin, R. S., Ardalan, B., and Ohnuma, T. Pharmacokinetic and biochemical studies on acivicin in Phase I clinical trials. Cancer Res., 45: 4460-4463, 1985.
18. Lalonde, R. L. Pharmacodynamics. In: W. E. Evans, J. J. Schentag, and W. J. Jusko (eds.), Applied Pharmacokinetics: Principles of Therapeutic Drug Monitoring, pp. 4-1-4-33. Vancouver, WA: Applied Therapeutics, 1992.
19. McGovren, J. P., Willians, M. G., Tan, A. H., Von Voigtlander, P. F., Piercey, M. F., Einspahr, F. J., and Schreur, P. J. K. D. Animal behavioral and neurochemical effects of CNS toxic amino acid antitumor agent acivicin. Res. Commun. Chem. Pathol. Pharmacol., 63: 215-229, 1989.
20. Taylor, S. A., Crowley, J., Pollock, T. W., Eyre, H. J., Jaeckle, C., Hynes, H. E., and Stephens, R. L. Objective antitumor activity of acivicin in patients with recurrent CNS maligancies: a Southwest Oncology Group Trial. J. Clin. Oncol., 9: 1476-1479, 1991.
21. Maroun, J. A., Maksymiuk, A. Eisenhawer, D. J., Stewart, D. J., Young, V., and Pater, J. Phase II study of acivicin in non-small cell lung cancer: a National Cancer Institute of Canada Study. Cancer Treat. Rep., 70: 1327-1328, 1986.