Phase I trial and pharmacokinetics of fenretinide in children with neuroblastoma

Clinical Cancer Research

Volumn 9, Issue 6, 2003, Pages 2032-2039

  Garaventa, Alberto ^a   Luksch, Roberto ^b   Lo Piccolo, Maria Serena ^a   Cavadini, Elena ^b   Montaldo, Paolo G ^a   Pizzitola, Maria Rosa ^a   Boni, Luca ^c   Ponzoni, Mirco ^a   Decensi, Andrea ^d   De Bernardi, Bruno ^a   Bellani, Franca Fossati ^b   Formelli, Franca ^b  

^a G GASLINI INSTITUTE   (Italy)

^b NATIONAL CANCER INSTITUTE   (Italy)

^c UNIVERSITY OF GENOA   (Italy)

^d EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

FENRETINIDE; RETINOID DERIVATIVE; RETINOL;

ADOLESCENT; ADULT; AMINOTRANSFERASE BLOOD LEVEL; APOPTOSIS; ARTICLE; BRAIN PSEUDOTUMOR; CHILD; CHILDHOOD CANCER; CHOLELITHIASIS; CLINICAL TRIAL; CONJUNCTIVITIS; DIARRHEA; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG DOSE REGIMEN; DRUG RESPONSE; DRUG WITHDRAWAL; DRY SKIN; FEMALE; HEADACHE; HERPES ZOSTER; HUMAN; LENTIGO; LIP DISEASE; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; MAXIMUM TOLERATED DOSE; NAIL DYSTROPHY; NEUROBLASTOMA; NIGHT BLINDNESS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; SIDE EFFECT; SKIN TOXICITY; TREATMENT OUTCOME; XEROSIS;

ADOLESCENT; ADULT; ANTINEOPLASTIC AGENTS; CHILD; CHILD, PRESCHOOL; FEMALE; FENRETINIDE; HUMANS; MALE; NEUROBLASTOMA; VITAMIN A;

EID: 0038176443     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (28)

1. Miller, R. W., Young, J. L., Jr., and Novakovi, C. B. Childhood cancer. Cancer (Phila.), 75: 395-405, 1995.
2. Ladenstein, R., Philip, T., Lasset, C., Hartmann, O., Garaventa, A., Pinkerton, R., Michon, J., Pritchard, J., Klingebiel, T., Kremens, B., Pearson, A., Coze, C., Paolucci, P., Frappaz, D., Gadner, H., and Chauvin, F. Multivariate analysis of risk factors in stage 4 neuroblastoma patients over the age of one year treated with megatherapy and stem-cell transplantation: a report from the European Bone Marrow Transplantation Solid Tumor Registry. J. Clin. Oncol., 16: 953-965, 1998.
3. Matthay, K. K., Villablanca, J. G., Seeger, R. C., Stram, O. D., Harris, R. E., Ramsay, N. K., Swift, P., Shimada, H., Black, C. T., Brodeur, G. M., Gerbing, R. B., and Reynolds, C. P. Treatment of high-risk neuroblastoma with intensive chemotherapy, radiotherapy, autologous bone marrow transplantation, and 13-cis-retinoic acid. Children's Cancer Group. N. Engl. J. Med., 341: 1165-1173, 1999.
4. Kushner, B. H., Kramer, K., and Cheung, N. K. Phase II trial of the anti-G(D2) monoclonal antibody 3F8 and granulocyte-macrophage colony-stimulating factor for neuroblastoma. J. Clin. Oncol., 19: 4189-4194, 2001.
5. Garaventa, A., Bellagamba, O., Lo Piccolo, M. S., Milanaccio, C., Lanino, E., Bertolazzi, L., Villavecchia, G. P., Cabria, M., Scopinaro, G., Claudiani, F. and De Bernardi, B. 131I-Metaiodobenzylguanidine (131I-MIBG) therapy for residual neuroblastoma: a mono-institutional experience with 43 patients. Br. J. Cancer, 81: 1378-1384, 1999.
6. Adamson, P. C., Reaman, G., Finklestein, J. Z. Feusner, J., Berg, S. L., Blaney, S. M., O'Brien, M., Murphy, R. F., and Balis, F. M. Phase I trial and pharmacokinetic study of all-trans-retinoic acid administered on an intermittent schedule in combination with interferon-α2a in pediatric patients with refractory cancer. J. Clin. Oncol., 15: 3330-3337, 1997.
7. Adamson, P. C., Widemann, B. C., Reaman, G. H., Seibel, N. L., Murphy, R. F., Gillespie, A. F., and Balis, F. M. A Phase I trial and pharmacokinetic study of 9-cis-retinoic acid (ALRT1057) in pediatric patients with refractory cancer: a joint pediatric oncology branch. National Cancer Institute, and Children's Cancer Group study. Clin. Cancer Res., 7: 3034-3039, 2001.
8. Finklestein, J. Z., Krailo, M. D., Lenarsky, C., Ladisch, S., Blair, G. K., Reynolds, C. P., Sitarz, A. L., and Hammond, G. D. 13-Cis-retinoic acid (NSC 122758) in the treatment of children with metastatic neuroblastoma unresponsive to conventional chemotherapy: report from the Children's Cancer Study Group. Med. Pediatr. Oncol., 20: 307-311, 1992.
9. Formelli, F., Barua, A. B., and Olson, J. Bioactivities of N-(4-hydroxyphenyl)retinamide and retinoyl β-glucuronide. FASEB J., 10: 1014-1024, 1996.
10. Di Vinci, A., Geido, E., Infusini, E., and Giaretti, W. Neuroblastoma cell apoptosis induced by the synthetic retinoid N-(4- hydroxyphenyl)retinamide. Int. J. Cancer, 59: 422-426, 1994.
11. Ponzoni, M., Bocca, P., Chiesa, V., Decensi, A., Pistola, V., Raffaghello, L., Rozzo, C., and Montaldo, P. G. Differential effects of N-(4-hydroxyphenyl)retinamide and retinoic acid on neuroblastoma cells: apoptosis versus differentiation. Cancer Res., 55: 853-861, 1995.
12. Rozzo, C., Chiesa, V., Caridi, G., Pagnan, G., and Ponzoni, M. Induction of apoptosis in human neuroblastoma cells by abrogation of integrin-mediated cell adhesion. Int. J. Cancer, 70: 688-698, 1997.
13. Maurer, B. J., Metelitsa, L. S., Seeger, R. C., Cabot, M. C., and Reynolds, C. P. Increase of ceramide and induction of mixed apoptosis/necrosis by N-(4-hydroxyphenyl)-retinamide in neuroblastoma cell lines. J. Natl. Cancer. Inst. (Bethesda), 91: 1138-1146, 1999.
14. Veronesi, U., De Palo, G., Marubini, E., Costa, A., Formelli, F., Mariani, L., Decensi, A., Camerini, T., Del Turco, M. R., Di Mauro, M. G., Muraca, M. G., Del Vecchio, M., Pinto, C., D'Aiuto, G., Boni, C., Campa, T., Magni, A., Miceli, R., Perloff, M., Malone, W. F., and Sporn, M. B. Randomized trial of fenretinide to prevent second breast malignancy in women with early breast cancer. J. Natl. Cancer. Inst. (Bethesda), 91: 1847-1856, 1999.
15. Camerini, T., Mariani, L., De Palo, G., Marubini, E., Di Mauro, M. G., Decensi, A., Costa, A., and Veronesi, U. Safety of the synthetic retinoid fenretinide: long-term results from a controlled clinical trial for the prevention of contralateral breast cancer. J. Clin. Oncol., 19: 1664-1670, 2001.
16. Formelli, F., Carsana, R., Costa, A., Buranelli, F., Campa, T., Dossena, G., Magni, A., and Pizzichetta, M. Plasma retinol level reduction by the synthetic retinoid fenretinide: a one year follow-up study of breast cancer patients. Cancer Res., 49: 6149-6152, 1989.
17. Formelli, F. Clerici, M., Campa, T., Di Mauro, M. G., Magni, A., Mascotti, G., Moglia, D., De Palo, G., Costa, A., and Veronesi, U. Five-year administration of fenretinide: pharmacokinetics and effects on plasma retinol concentrations. J. Clin. Oncol., 11: 2036-2042, 1993.
18. National Cancer Institute. NCI common toxicity criteria, version 1. In: Investigator's Handbook: A Manual of Participants in Clinical Trials of Investigational Agents Sponsored by the Division of Cancer Treatment, National Cancer Institute. Bethesda, MD, U. S. Department of Health and Human Services, Public Health Service, National Institutes of Health, October 1993.
19. Brodeur, G. M., Pritchard, J., Berthold, F., Carlsen, N. L., Castel, V., Castleberry, R. P., De Bernardi, B., Evans, A. E., Favrot, M., Hedborg, F., Kaneko, M., Kemshead, J., Lampert, F., Lee, R. E. J., Thomas Look, A., Pearson, A. D. J., Philip, T., Roald, B., Sawada, T., Seeger, R. C., Tsuchida, Y., and Voute, P. A. Revisions of the international criteria for neuroblastoma diagnosis, staging, and response to treatment. J. Clin. Oncol., 11: 1466-1477, 1993.
20. Gibaldi, M., and Perrier. D. (eds). Pharmacokinetics, Ed. 2, Vol. 15, pp. 445-449. New York: Marcel Dekker, Inc., 1982.
21. Villablanca, J. G., Khan, A. A., Avramis, V. I., Seeger, R. C., Matthay, K. K., Ramsay, N. K., and Reynolds, C. P. Phase I trial of 13-cis-retinoic acid in children with neuroblastoma following bone marrow transplantation. J. Clin. Oncol., 13: 894-901, 1995.
22. Villa, M. L., Ferrario, E., Trabattoni, D., Formelli, F., De Palo, G., Magni, A., Veronesi, U., and Clerici, E. Retinoids, breast cancer and NK cells. Br. J. Cancer, 68: 845-850, 1993.
23. Angulo, A., Chandraratna, R. A., LeBlanc, J. F., and Ghazal, P. Ligand induction of retinoic acid receptors alters an acute infection by murine cytomegalovirus. J. Virol., 72: 4589-4600, 1998.
24. Smith, M. A., Adamson, P. C., Balis, 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.
25. Muindi, J., Frankel, S., Miller, W., 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 promyelocytic leukemia. Blood, 79: 299-303, 1992.
26. Formelli, F., Cavadini, E., Mascheroni, L., Belli, F., and Cascinelli, N. Pharmacokinetics and effects on plasma retinol concentrations of 13-cis-retinoic acid in melanoma patients. Br. J. Cancer, 76: 1655-1660, 1997.
27. Villablanca, J. G., Ames, M. M., Reid, J. M., Bagniewski, P., Krailo, M., Reynolds, C. P. Phase I trial of oral [N(4-hydroxyphenyl)-retinamide] (4-HPR) in children with resistant/recurrent solid tumors: a children's Cancer Group Study (CCG 09709). Proc. Am. Soc. Clin. Oncol. Annu. Meet., 21: 398a, 2002.
28. Wu, J. M., DiPietrantonio, A. M., Hsieh, T. C. Mechanism of fenretinide (4 HPR)-induced cell death. Apoptosis, 6: 377-388, 2001.