Phase I and pharmacological study of weekly administration of the polyamine synthesis inhibitor SAM 486A (CGP 48 664) in patients with solid tumors

Clinical Cancer Research

Volumn 6, Issue 5, 2000, Pages 1736-1743

  Eskens, Ferry A L M ^a,f   Greim, Gudrun A ^b   Van Zuylen, Cornelia ^a   Wolff, I ^b   Denis, Louis J ^a   Planting, André S Th ^a   Muskiet, Frits A ^c   Wanders, Jantien ^d   Barbet, Nicolas C ^e   Choi, Les ^e   Capdeville, Renaud ^e   Verweij, Jaap ^a   Hanauske, A R ^g   Bruntsch, Uta ^b  

^a ERASMUS MC CANCER INSTITUTE   (Netherlands)

^b City Hospital   (Germany)

^c UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^d VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^e NOVARTIS PHARMA AG   (Switzerland)

^f ERASMUS MEDICAL CENTER   (Netherlands)

^g University Hospital Rotterdam ^*

Author keywords

[No Author keywords available]

Indexed keywords

4 AMIDINO 1 INDANONE 2' AMIDINOHYDRAZONE;

ADULT; AGED; ARTICLE; CANCER CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; DOSE RESPONSE; DRUG EFFECT; DRUG SCREENING; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPOTENSION; MALE; NEUROTOXICITY; PARESTHESIA; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SOLID TUMOR; SOMNOLENCE; SYNCOPE;

ADULT; AGED; AMIDINES; ANOREXIA; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; DIARRHEA; DOSE-RESPONSE RELATIONSHIP, DRUG; FATIGUE; FEMALE; HEMATOLOGIC DISEASES; HUMANS; INDANS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; NAUSEA; NEOPLASMS; POLYAMINES; TREATMENT OUTCOME; VOMITING;

EID: 17444446928     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (26)

1. Pegg, A. E. Polyamine metabolism and its importance in neoplastic growth and as a target for chemotherapy. Cancer Res., 48: 759-774, 1988.
2. Williams-Ashman, H. G., and Canellakis, Z. N. Polyamines in mammalian biology and medicine. Perspect. Biol. Med., 22: 421-453, 1979.
3. Porter, C. W., and Sufrin, J. R. Interference with polyamine biosynthesis and/or function by analogs of polyamines or methionine as a potential anticancer chemotherapeutic strategy. Anticancer Res., 6: 525-542, 1986.
4. Scalabrino, G., and Ferioli, M. E. Polyamines in mammalian tumors. Adv. Cancer Res., 35: 151-268, 1981.
5. Warrell, R. P., and Burchenal, J. H. Methylglyoxyl-bis (guanylhydrazone) (Methyl-GAG). Current status and future prospects. J. Clin. Oncol., 1: 52-65, 1983.
6. Regenass, U., Caravatti, G., Mett, H., Stanek, J., Schneider, P., Muller, M., Matter, A., Vertino, P., and Porter, C. W. New S-adenosylmethionine decarboxylase inhibitors with potent antitumor activity. Cancer Res., 52: 4712-4718, 1992.
7. Regenass, U., Mett, H., Stanek, J., Mueller, M., Kramer, D., and Porter, C. W. CGP 48 664, a new S-adenosylmethionine decarboxylase inhibitor with broad spectrum antiproliferative and antitumor activity. Cancer Res., 54: 3210-3217, 1994.
8. Manni, A., Badger, B., Wechter, R., Kunselman, S., Rossini, A., and Demers, L. Biochemical and growth-modulatory effects of the new S-adenosylmethionine decarboxylase inhibitor CGP 48 664 in malignant and immortalized human breast epithelial cells in culture. Int. J. Cancer, 62: 485-491, 1995.
9. Gutman, M., Beltran, P. J., Fan, D., Delworth, M. G., Singh, R. K., Wilson, M. R., and Fidler, I. J. Treatment of nude mice with 4-amidinoindan-1-one2′-amidinohydrazone, a new S-adenosylmethionine decarboxylase inhibitor, delays growth and inhibits metastases of human melanoma cells. Melanoma Res., 5: 147-154, 1995.
10. Thomas, T., Faaland, C. A., Adhikarakunnathu, S., and Thomas, T. J. Structure-activity relations of S-adenosyldecarboxylase inhibitors on the growth of MCF-7 breast cancer cells. Breast Cancer Res. Treat., 39: 293-306, 1996.
11. Dorhout, B., te Velde, R. J., Ferwerda, H., Kingma, A. W., De Hoog, E., and Muskiet, F. A. In vivo growth inhibition of L1210 leukemia by 4-amidinoindan-1-one 2′-amidinohydrazone, a new inhibitor of S-adenosylmethionine decarboxylase. Int. J. Cancer, 61: 214-217, 1995.
12. Delworth, M. G, Nishioka, K., and Pettaway, C. Systemic administration of 4-amidinoindanon-1-(2′-amidino)/hydrazone, a new inhibitor of S-adenosyl methionine decarboxylase, produces cytostasis of human prostate cancer in athymic nude mice. Int. J. Cancer, 65: 293-299, 1997.
13. O'Reilly, T., Cozens, R., and Mett, H. Evaluation of the antitumor activity of the S-adenosylmethionine decarboxylase (SAMDC) inhibitor SAM 486 alone and in combination with conventional cytotoxic agents. Proc. Am. Assoc. Cancer Res., 41: 409, 2000.
14. Division of Cancer Treatment, National Cancer Institute. Guidelines for Reporting of Adverse Drug Reactions. Bethesda, MD: National Cancer Institute, 1988.
15. WHO. WHO Handbook for Reporting Results of Cancer Treatment. Geneva, Switzerland: WHO, 1979.
16. Degen, P. H., and Zbinden, P. Automated quantitative determination of a new polyamine biosynthesis inhibitor (CGP 48 664) and a potential metabolite in human and animal plasma by high-performance liquid chromatography. J. Chromatogr. B. Biomed. Appl., 681: 339-345, 1996.
17. 8-spermidine derivatives in cultured L1210 leukemia cells. Cancer Res., 45: 2050-2057, 1985.
18. Paridaens, R., Uges, D. R. A., Barbet, N. C., Seeghers, M., van der Graaf, W. T. A., Lassus, M., Groen, H. J. M., Dumez, H., Muskiet, F., Man, A., van Oosterom, A. T., and de Vries, E. G. E. Phase I dose escalation and pharmacokinetic study of CGP 48 664, a new S-adenosylmethionine decarboxylase (SAMDC) inhibitor, administered in continuous infusion over 5 days in cancer patients with solid tumors. Proc. Am. Soc. Clin. Oncol., 17: 190a, 1998.
19. Siu, L. L., Rowinsky, E. K., Weiss, G. R., Hammond, L., Kraynak, M., Moczygemba, J., Choi, L., Barbet, N. C., DeMoor, C., Von Hoff, D. D., and Eckhart, S. G. A Phase I and pharmacokinetic (PK) study of the polyamine biosynthesis inhibitor CGP 48 664 in patients with advanced cancer. Proc. Am. Soc. Clin. Oncol., 17: 191a, 1998.
20. Kelsen, D. P., Yagoda, A., Warrell, R., Chapman, R., Wittes, R., Gralla, R. J., Casper, E., and Young, C. W. Phase II trials of methylglyoxal-bis (guanylhydrazone). Am. J. Clin. Oncol., 5: 221-225, 1982.
21. Hart, R. D., Ohnuma, T.. Holland, J. F., and Bruckner, H. Methyl-GAG in patients with malignant neoplasms: a Phase I re-evaluation. Cancer Treat. Rep., 66: 65-71, 1982.
22. Sordillo, P. P., Magill, G. B., and Welt, S. Phase II trial of methylglyoxal-bis-guanylhydrazone in patients with soft-tissue sarcomas. Am. J. Clin. Oncol., 8: 316-318, 1985.
23. Samson, S. K., Baker, L. H., Cummings, G., and talley, R. W. Phase II trial of methyl-GAG (NSC-32946) in squamous cell and adenocarcinoma of the lung. Am. J. Clin. Oncol., 5: 631-633, 1982.
24. Levine, A. M., Tulpule, A., Tessman, D., Kaplan, L., Giles, F., Luskey, B. D., Scadden, D. T., Northfelt, D. W., Silverberg, I., Wernz, J., Espina, B., and Von Hoff, D. Mitoguazone therapy in patients with refractory or relapsed AIDS-related lymphoma: results from a multicenter Phase II trial. J. Clin. Oncol., 15: 1094-1103, 1997.
25. 14C]methylglyoxal-bis (guanylhydrazone) in patients with leukemia. Cancer Res., 41: 1748-1750, 1981.
26. Rizzo, J., Levine, A. M., Weiss, G. R., Pearce, T., Kraynak, M., Mueck, R., Smith, S., Von Hoff, D. D., and Kuhn, J. G. Pharmacokinetic profile of mitoguazone (MGBG) in patients with AIDS related non-Hodgkin's lymphoma. Investig. New Drugs, 14: 227-234, 1996.