Phase I trial of 9-cis retinoic acid in adults with solid tumors

Clinical Cancer Research

Volumn 2, Issue 2, 1996, Pages 287-293

  Kurie, Jonathan M ^a,c   Lee, Jin Soo ^a   Griffin, Tom ^b   Lippman, Scott M ^a   Drum, Pat ^b   Thomas, Margaret P ^a   Weber, Cornelia ^c   Bader, Malorie ^a   Massimini, Giorgio ^a   Hong, Waun Ki ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b Clinical Research   (United States)

^c Produits Roche ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ISOTRETINOIN;

ADULT; AGED; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; DIARRHEA; FEMALE; HEADACHE; HUMAN; MALE; ORAL DRUG ADMINISTRATION; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SOLID TUMOR;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; TRETINOIN;

EID: 9044229141     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (42)

1. Giguere, V., Ong, E. S., Segui P., and Evans, R. M. Identification of a receptor for the morphogen retinoic acid. Nature (Lond.), 330: 624-629, 1987.
2. Petkovitch, M., Brand, N. J., Krust, A., and Chambon, P. A human retinoic acid receptor which belongs to the family of nuclear receptors. Nature (Lond.), 330: 444-450, 1987.
3. Brand, N., Petkovitch, M., Krust, A., Chambon, P., de The, H., Marchio, A., Thiollais, P., and Dejean A. Identification of a second human retinoic acid receptor. Nature (Lond.), 332: 851-853, 1988.
4. Krust, A., Kastner, P. H., Petkovitch, M., Zelent, A., and Chambon, P. A third human retinoic acid receptor, HRAR-γ. Proc. Natl. Acad. Sci. USA. 86: 5310-5314, 1989
5. Mangelsdorf, D., Ong, E. S., Dyck, J. A., and Evans, R. M. Nuclear receptor that identifies a novel retinoic acid response pathway. Nature (Lond.), 345: 224-229, 1990.
6. Mangelsdorf, D. J., Borgmeyer, U., Heyman, R. A., Zhou, J. Y., Ong, E. S., Oro, A. E , Kakizuka, A., and Evans, R M. Characterization of three RXR genes that mediate the effects of 9-cis retinoic acid. Genes & Dev., 6: 329-344, 1992.
7. 3 signaling. Nature (Lond.), 355: 446-449, 1992.
8. Durand, B., Saunders, M., Leroy, P., Leid, M., and Chambon, P. All-trans and 9-cis retinoic acid induction of CRABPII transcription is mediated by RAR-RXR heterodimers bound to DR1 and DR2 repeated motifs. Cell 71: 73-85, 1992.
9. Yu, V. C., Delser, C., Andersen, B., Holloway, J. M., Devary, O. V., Näär, A., Kim, S. Y., Boulin, J-M, Glass, C. K., and Rosenfeld, M. G. RXRβ: a coregulator that enhances binding of retinoic acid, thyroid hormone, and vitamin D receptors to their cognate response elements. Cell, 67: 1251-1266, 1991.
10. Mangelsdorf, D. J., Umesono, K., Kliewer, S. A., Borgmeyer, U., Ong, E. S., and Evans, R. M. A direct repeat in the cellular retinol-binding protein type II gene confers differential regulation by RXR and RAR. Cell. 60: 555-561, 1991.
11. 3 receptors. Cell, 65: 1255-1266, 1991.
12. Heyman, R. A., Mangelsdorf, D. J., Dyck, J. A., Stein, R. B., Eichele, G., Evans R M., and Thaller, C. 9-cis retinoic acid is a high affinity ligand for the retinoid X receptor. Cell, 68, 397-406, 1992.
13. Levin, A. A., Sturzenbecker, L. J., Kazmer, S., Bosakowski, T., Haselton, C., Allenby, G., Speck, J., Kratzeisen, C., Rosenberger, M., Lovey, A., and Grippo, J. F. 9-cis retinoic acid stereoisomer binds and activates the nuclear receptor RXR α. Nature (Lond.), 355: 359-361, 1992
14. Hong, W. K., Endicott, J, Itri, L. M., Doos, W., Batsakis, J. G., Bell, R., Fofonoff, S., Byers, R., Atkinson, E. N., Vaughan, C., Toth, B. B., Kramer, A., Dimery, I. W., Skipper, P., and Strong, S 13-cis retinoic acid in the treatment of oral leukoplakia. N. Engl. J. Med., 315: 1501-1505, 1986.
15. Hong, W. K., Lippman, S. M., Itri, L. M., Karp, D. D., Lee, J. S., Byers, R. M., Schantz, S. P., Kramer, A. M., Lotan, R., Peters, L. J., Dimery, I. W., Brown, B. W., and Goepfert, H. Prevention of second primary tumors with isotretinoin in squamous cell carcinoma of the head and neck. N. Engl. J. Med., 323: 795-801, 1990.
16. Pastorino, U., Infante, M., Maioli, M., Chiesa, G., Buyse, M., Firket, P., Rosmentz, N., Clerici, M., Soresi, E., Valente, M., Belloni, P. A., and Ravasi, G. Adjuvant treatment of stage I lung cancer with high dose vitamin A. J. Clin. Oncol., 11: 1216-1222, 1993.
17. Warrell, R. P., Frankel, S. R., Miller, W. H., Jr., Scheinberg, D.A , Itri, L. M., Hittelman, W. N., Nyas, R., Andreeff, M., Tafuri, A., Jakubowski, A., Gabrilove, J., Gordon, M. S., and Dmitrovsky, E. Differentiation therapy of acute promyelocytic leukemia with tretinoin (all-trans retinoic acid). N. Engl. J. Med., 324: 1385-1393, 1991.
18. Huang, M. E., Ye, Y. C., and Chen, S. R., Use of all-trans retinoic acid in the treatment of acute promyelocytic leukemia. Blood, 72: 567-572, 1988.
19. de The, H., Chomienne, C., and Lanotte., M. The t(15:17) translocation of acute promyelocytic leukemia fuses the retinoic acid receptor alpha gene to a novel transcribed locus. Nature (Lond.). 347: 558-561, 1990.
20. Cheng, A-L., Su. I-J., Chen, C-C., Tien, H-F., Lay, J-D., Chen, B-R., Pu, Y-S., Hong, R-L., Shen, M-C., Wang, C-H., and Chen, Y-C. Use of retinoic acids in the treatment of peripheral T-cell lymphoma: a pilot study. J Clin. Oncol, 12: 1185-1192, 1994.
21. Castleberry, R. P., Emanual, P. D., Zuckerman, K. S., Cohn S., Strauss L., Byrd, R. L., Homans, A., Chaffee, S., Nitschke, R., and Gualtieri, R. J. A pilot study of isotretinoin in the treatment of juvenile chronic myelogenous leukemia. N. Engl. J. Med., 331: 1680-1684, 1994.
22. Lippman, S. M., Kavanagh, J., Paredes-Espinaza, M., Delgadillo-Madrueno, F., Paredes-Casillas, P., Hong, W. K., Holdener, E., and Krakoff, I. H. 13-cis retinoic acid plus interferon alpha-2a highly active systemic therapy for squamous cell carcinoma of the cervix. J. Natl. Cancer Inst, 84: 241-245, 1992.
23. Lippman, S. M., Parkinson, D. R., Itri, L. M., Weber, R. S., Schantz, S. P., Ota, D. M., Schusterman, M. A., Krakoff, I. H., Gutterman, J. U., and Hong, W. K. 13-cis retinoic acid plus interferon alpha-2a: Effective combination therapy for advanced squamous cell carcinoma of the skin. J. Natl. Cancer Inst., 84: 235-241, 1992.
24. Motzer, R. J., Murray-Law, T., Schwarz, L., Fischer, P., Scher, H. I., Nanus, D. M. Antitumor activity of interferon alfa-2a (IFN-α) and 13-cis retinoic acid (c-RA) in patients with advanced renal cell carcinoma (RCC) (Abstract 713). Proc. Am. Soc. Clin. Oncol., 13: 232, 1994.
25. Rigas, J. R., Miller, V. A., Benedetti, F. M., Tong, W. P., Gill, G. M., Truglia, J. A., Ulm, E., Loewen, G., and Warrell, R. P., Jr. Phase I clinical trial and pharmacologic study of 9-cis retinoic acid (Abstract 370). Proc. Am. Soc. Clin. Oncol., 13: 171, 1995.
26. Moasser, M. M., DeBlasio, A., and Dmitrovsky, E. Response and resistance to retinoic acid are mediated through the retinoic acid nuclear receptor gamma in human teratocarcinomas. Oncogene. 9: 833-840, 1994.
27. Lee, J. S., Newman, R. A., Lippman, S. M., Huber, M. H., Minor, T., Raber, M. N., Krakoff, I. H., and Hong, W. K. Phase I evaluation of all-trans-retinoic acid in adults with solid tumors. J. Clin Oncol, 11: 959-966, 1993.
28. Rubin, M., Fenig, E., Rosenauer, A., Menendez-Botet, C., Achkar, C., Bentel, J. M., Yahalom, J., Mendelsohn, J., and Miller, W. J , Jr. 9-cis retinoic acid inhibits growth of breast cancer cells and downregulates estroaen receptor RNA and protein. Cancer Res., 54: 6549-6556, 1994.
29. Schule, R., Rangarajan, P., Yang, N , Kliewer, S., Ransone, L. J., Bolado, J., Verma, I. M., and Evans, R. M. Retinoic acid is a negative regulator of AP-1-responsive genes. Proc. Natl. Acad. Sci. USA, 88: 6092-6096, 1991.
30. Smith, M. A., Adamson, P. C., Bolis, F. M., Feusner, J., Aronson, L, Murphy, R. F., Horowitz, M. E., Reaman, G., Hammond, G. D., Fenton, R. M., Connaghan, G. D., Hittelman, W. N., and Poplack, D. G. Phase I and pharmacokinetic evaluation of all-trans-retinoic acid in pediatric patients with cancer. J. Clin. Oncol., 10: 1666-1673, 1992.
31. Muindi, J., Frankel, S. R., Miller, W. H., Jr., Jakubowski, A., Scheinberg, D. A., Young, C. W., Dmitrovsky, E., and Warrell, R. P., Jr. Continuous treatment with all-trans-retinoic acid causes a progressive reduction in plasma drug concentrations: implications for relapse and retinoid "resistance" in patients with acute promyelecytic leukemia. Blood, 79: 299-303, 1992.
32. Adamson, P. C., Boylan, J. F., Balis, F. M., Murphy, R. F., Godwin, K. A., Gudas, L. J., and Poplack, D. G. Time course of induction of metabolism of all-trans-retinoic acid and the up-regulation of cellular retinoic acid-binding protein. Cancer Res., 53: 472-476, 1993.
33. Bossche, H. V., and Willemsens, G. Retinoic acid and cytochrome P-450. In: J. H. Saurat (ed.), Retinoids: 10 Years On; pp. 79-88. Basel, Switzerland: Karger, 1991.
34. Roberts, A. B. Microsomal oxidation of retinoic acid in hamster liver, intestine, and testis. Ann. N. Y. Acad. Sci., 359: 45-53, 1981.
35. Williams, J. B., and Napoli, J. L. Metabolism of retinoic acid and retinol during differentiation of F9 embryonal carcinoma cells. Proc. Natl. Acad. Sci. USA, 82: 4658-4662, 1985.
36. Roberts, A. B., and DeLuca, H. F. Pathways of retinol and retinoic acid metabolism in vivo. Biochem. Biophys. J., 102, 600-605, 1967.
37. Williams, J. B., and Napoli, J. L. Inhibition of retinoic acid metabolism by imidazole antimycotics in F9 embryonal carcinoma cells. Biochem Pharmacol., 36: 1386-1388, 1987.
38. Van Wauwe, J. P., Coene M-C., Goossens, J., Van Nijen G., and Lauwers, W. Effects of cytochrome P-450 inhibitors on the in vivo metabolism of all-trans-retinoic acid. J. Pharmacol. Exp. Ther., 245: 718-722, 1988.
39. Van Wauwe, J. P., Coene M-C., Goossens, J., Cools, W., and Monbaliu, J. Effects of cytochrome P-450 inhibitors on the in vivo metabolism of all-trans-retinoic acid in rats. J. Pharmacol. Exp Ther., 252: 365-369, 1990.
40. Francis, P. A., Rigas, J. R., Muindi, J. R., Kris, M. G., Young, C. W., and Warrell, R. P., Jr. Modulation of all-trans-retinoic acid (RA) pharmacokinetics by a cytochrome P-450 enzyme system inhibitor (Abstract). Proc. Am. Soc. Clin. Oncol., 11: 108, 1992.
41. Lee, J. S., Newman, R. A., Lippman, S. M., Fossella, F., Calayag, M., Raber, M. N., Krakoff, I. H., and Hong, W. K. Phase I evaluation of all-trans retinoic acid with and without ketocanazole in adults with solid tumors. J. Clin. Oncol., in press, 1995.
42. Adamson, P. C., Bailey, J., Pluda, J., Poplack, D. G., Bauza, S., Murphy, R. F., Yarchoan, R., and Balis, F. M. Pharmacokinetics of all-trans-retinoic acid administered on an intermittent schedule. J. Clin. Oncol., 13: 1238-1241, 1995.