Phase I Trial of Temozolomide and Protracted Irinotecan in Pediatric Patients with Refractory Solid Tumors

Clinical Cancer Research

Volumn 10, Issue 3, 2004, Pages 840-848

  Wagner, Lars M ^a,c   Crews, Kristine R ^b   Iacono, Lisa C ^b   Houghton, Peter J ^b   Fuller, Christine E ^b   McCarville, M Beth ^b   Goldsby, Robert E ^a   Albritton, Karen ^a   Stewart, Clinton F ^b   Santana, Victor M ^b  

^a PRIMARY CHILDREN'S MEDICAL CENTER   (United States)

^b ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^c CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

7 ETHYL 10 HYDROXYCAMPTOTHECIN; CAMPTOSTAR; IRINOTECAN; METHYLATED DNA PROTEIN CYSTEINE METHYLTRANSFERASE; TEMOZOLOMIDE;

ADOLESCENT; ADULT; ANTINEOPLASTIC ACTIVITY; ARTICLE; BACTEREMIA; BONE MARROW SUPPRESSION; CHILD; CHILDHOOD CANCER; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE ASSOCIATION; DNA REPAIR; DOSE RESPONSE; DOSE TIME EFFECT RELATION; DRUG CROSS REACTIVITY; DRUG METABOLISM; EVALUATION; EWING SARCOMA; FEMALE; FEVER; HUMAN; LIVER TOXICITY; MALE; MAXIMUM TOLERATED DOSE; NAUSEA; NEUROBLASTOMA; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PHENOTYPE; PRIORITY JOURNAL; PROTEIN EXPRESSION; SOLID TUMOR; STEM CELL TRANSPLANTATION; STOMATITIS; THROMBOCYTOPENIA; VOMITING; XENOGRAFT;

ADOLESCENT; ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AREA UNDER CURVE; BASE PAIR MISMATCH; CAMPTOTHECIN; CELL LINE, TUMOR; CHILD; CHILD, PRESCHOOL; DACARBAZINE; DNA REPAIR; FEMALE; HUMANS; IMMUNOHISTOCHEMISTRY; INFANT; MALE; MAXIMUM TOLERATED DOSE; NEOPLASMS; O(6)-METHYLGUANINE-DNA METHYLTRANSFERASE; PHENOTYPE; TIME FACTORS;

EID: 10744231592     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-03-0175     Document Type: Article

References (46)

1. Masuda, N., Kudoh, S., and Fukuoka, M. Irinotecan (CPT-11): pharmacology and clinical applications. Crit. Rev. Oncol. Hematol., 24: 3-26, 1996.
2. Ychou, M., Raoul, J. L., Desseigne, F., Borel, C., Caroli-Bosc, F. X., Jacob, J. H., Seitz, J. F., Kramar, A., Hua, A., Lefebvre, P., Couteau, C., and Merrouche, Y. High-dose, single-agent irinotecan as first-line therapy in the treatment of metastatic colorectal cancer. Cancer Chemother. Pharmacol., 50: 383-391, 2002.
3. Slater, S., Shamash, J., Wilson, P., Gallagher, C. J., and Slevin, M. L. Irinotecan, cisplatin and mitomycin in inoperable gastro-oesophageal and pancreatic cancers: a new active regimen. Br. J. Cancer, 87: 850-853, 2002.
4. Bleiberg H. CPT-11 in gastrointestinal cancer. Eur. J. Cancer, 35: 371-379, 1999.
5. Noda, K., Nishiwaki, Y., Kawahara, M., Negoro, S., Sugiura, T., Yokoyama, A., Fukuoka, M., Mori, K., Watanabe, K., Tamura, T., Yamamoto, S., and Saijo, N. Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer. N. Engl. J. Med., 346: 85-91, 2002.
6. Friedman, H. S., Petros, W. P., Friedman, A. H., Schaaf, L. J., Kerby, T., Lawyer, J., Parry, M., Houghton, P. J., Lovell, S., Rasheed, K., et al. Irinotecan therapy in adults with recurrent or progressive malignant glioma. J. Clin. Oncol., 17: 1516-1525, 1999.
7. Bodurka, D. C., Levenback, C., Wolf, J. K., Gano, J., Wharton, J. T., Kavanagh, J. J., and Gershenson, D. M. Phase II trial of irinotecan in patients with metastatic epithelial ovarian cancer or peritoneal cancer. J. Clin. Oncol., 21: 291-297, 2003.
8. Thompson, J., Zamboni, W. C., Cheshire, P. J., Lutz, L., Luo, X., Li, Y., Houghton, J. A., Stewart, C. F., and Houghton, P. J. Efficacy of systemic administration of irinotecan against neuroblastoma xenografts. Clin. Cancer Res., 3: 423-431, 1997.
9. Houghton, P. J., Cheshire, P. J., Hallman, J. D., II, Lutz, L., Friedman, H. S., Danks, M. K., and Houghton, J. A. Efficacy of topoisomerase I inhibitors, topotecan and irinotecan, administered at low dose levels in protracted schedules to mice bearing xenografts of human tumors. Cancer Chemother. Pharmacol., 36: 393-403, 1995.
10. Furman, W. L., Stewart, C. F., Poquette, C. A., Pratt, C. B., Santana, V. M., Zamboni, W. C., Bowman, L. C., Ma, M. K., Hoffer, F. A., Meyer, W. H., et al. Direct translation of a protracted irinotecan schedule from a xenograft model to a Phase I trial in children. J. Clin. Oncol., 17: 1815-1824, 1999.
11. Blaney, S., Berg, S. L., Pratt, C., Weitman, S., Sullivan, J., Luchtman-Jones, L., and Bernstein, M. A Phase I study of irinotecan in pediatric patients: a pediatric oncology group study. Clin. Cancer Res., 7: 32-37, 2001.
12. Mugishima, H., Matsunaga, T., Yagi, K., Asami, K., Mimaya, J., Suita, S., Kishimoto, T., Sawada, T., Tsuchida, Y., and Kaneko, M. Phase I study of irinotecan in pediatric patients with malignant solid tumors. J. Pediatr. Hematol. Oncol., 24: 94-100, 2002.
13. Cosetti, M., Wexler, L. H., Calleja, E., Trippett, T., LaQuaglia, M., Huvos, A. G., Gerald, W., Healey, J. H., Meyers, P. A., and Gorlick, R. Irinotecan for pediatric solid tumors: the Memorial Sloan-Kettering experience. J. Pediatr. Hematol. Oncol., 24: 101-105, 2002.
14. Turner, C. D., Gururangan, S., Eastwood, J., Bottom, K., Watral, M., Beason, R., McLendon, R. E., Friedman, A. H., Tourt-Uhlig, S., Miller, L. L., and Friedman, H. S. Phase II study of irinotecan (CPT-11) in children with high-risk malignant brain tumors: the Duke experience. Neuro-oncol., 4: 102-108, 2002.
15. Garcia-Carbonero, R., and Supko, J. G. Current perspectives on the clinical experience, pharmacology, and continued development of the camptothecins. Clin. Cancer Res., 8: 641-661, 2002.
16. 6 alkylation in the mechanism of cytotoxicity of imidazotetrazinones. Biochem. Pharmacol., 36: 457-462, 1987.
17. Yung, W. K., Prados, M. D., Yaya-Tur, R., Rosenfeld, S. S., Brada, M., Friedman, H. S., Albright, R., Olson, J., Chang, S. M., O'Neill, A. M., et al. Multicenter Phase II trial of temozolomide in patients with anaplastic astrocytoma or anaplastic oligoastrocytoma at first relapse. Temodal Brain Tumor Group. J. Clin. Oncol., 17: 2762-2771, 1999.
18. Bower, M., Newlands, E. S., Bleehen, N. M., Brada, M., Begent, R. J., Calvert, H., Colquhoun, I., Lewis, P., and Brampton, M. H. Multicentre CRC Phase II trial of temozolomide in recurrent or progressive high-grade glioma. Cancer Chemother. Pharmacol., 40: 484-488, 1997.
19. Bleehen, N. M., Newlands, E. S., Lee, S. M., Thatcher, N., Selby, P., Calvert, A. H., Rustin, G. J., Brampton, M., and Stevens, M. F. Cancer Res. Campaign Phase II trial of temozolomide in metastatic melanoma. J. Clin. Oncol., 13: 910-913, 1995.
20. Middlemas, D. S., Stewart, C. F., Kirstein, M. N., Poquette, C., Friedman, H. S., Houghton, P. J., and Brent, T. P. Biochemical correlates of temozolomide sensitivity in pediatric solid tumor xenograft models. Clin. Cancer Res., 6: 998-1007, 2000.
21. 6-methylguanine-DNA methyltransferase and mismatch repair phenotypes in xenograft models. Clin. Cancer Res., 6: 4110-4118, 2000.
22. Nicholson, H. S., Krailo, M., Ames, M. M., Seibel, N. L., Reid, J. M., Liu-Mares, W., Vezina, L. G., Ettinger, A. G., and Reaman, G. H. Phase I study of temozolomide in children and adolescents with recurrent solid tumors: a report from the Children's Cancer Group. J. Clin. Oncol., 16: 3037-3043, 1998.
23. Estlin, E. J., Lashford, L., Ablett, S., Price, L., Gowing, R., Gholkar, A., Kohler, J., Lewis, I. J., Morland, B., Pinkerton, C. R., et al. Phase I study of temozolomide in paediatric patients with advanced cancer. United Kingdom Children's Cancer Study Group. Br. J. Cancer, 78: 652-661, 1998.
24. Patel, V. J., Elion, G. B., Houghton, P. J., Keir, S., Pegg, A. E., Johnson, S. P., Dolan, M. E., Bigner, D. D., and Friedman, H. S. Schedule-dependent activity of temozolomide plus CPT-11 against a human central nervous system tumor-derived xenograft. Clin. Cancer Res., 6: 4154-4157, 2000.
25. 6-methylguanine-DNA methyltransferase (MGMT) as a determinant of resistance to camptothecin derivatives. Jpn. J. Cancer Res., 93: 93-102, 2002.
26. Kuhn, J. G. Influence of anticonvulsants on the metabolism and elimination of irinotecan. A North American Brain Tumor Consortium preliminary report. Oncology (Huntingt.), 16: 33-40, 2002.
27. Owens, T. S., Dodds, H., Fricke, K., Hanna, S. K., and Crews, K. R. High-performance liquid chromatographic assay with fluorescence detection for the simultaneous measurement of carboxylate and lactone forms of irinotecan and three metabolites in human plasma. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 788: 65-74, 2003.
28. D'Argenio, D. Z. ADAPT II user's guide, Ed. 1, University of Southern California. Los Angeles: Biomedical Simulations Resource, 1990.
29. Panetta, J. C., Kirstein, M. N., Gajjar, A., Nair, G., Fouladi, M., Heideman, R. L., Wilkinson, M., and Stewart, C. F. Population pharmacokinetics of temozolomide and metabolites in infants and children with primary central nervous system tumors. Cancer Chemother. Pharmacol., 52: 435-441, 2003.
30. Baker, S. D., Wirth, M., Statkevich, P., Reidenberg, P., Alton, K., Sartorius, S. E., Dugan, M., Cutler, D., Batra, V., Grochow, L. B., Donehower, R. C., and Rowinsky, E. K. Absorption, metabolism, and excretion of 14C-temozolomide following oral administration to patients with advanced cancer. Clin. Cancer Res., 5: 309-317, 1999.
31. Crews, K. R., Stewart, C. F., Jones-Wallace, D., Thompson, S. J., Houghton, P. J., Heideman, R. L., Fouladi, M., Bowers, D. C., Chintagumpala, M. M., and Gajjar, A. Altered irinotecan pharmacokinetics in pediatric high-grade glioma patients receiving enzyme-inducing anticonvulsant therapy. Clin. Cancer Res., 8: 2202-2209, 2002.
32. Radomski, K. M., Stewart, C. F., Panetta, J. C., Houghton, P. J., and Furman, W. L. Phase I and pharmacokinetic study of oral irinotecan in pediatric patients with solid tumors. Proc. Am. Soc. Clin. Oncol., 19: 503a, 2000.
33. Brownstein, M. J., Carpten, J. D., and Smith, J. R. Modulation of non-templated nucleotide addition by Taq DNA polymerase: primer modifications that facilitate genotyping. Biotechniques, 20: 1004-1010, 1996.
34. 6-methylguanine. Cancer Res., 61: 53-58, 2001.
35. Vassal, G., Boland, I., Santos, A., Bissery, M. C., Terrier-Lacombe, M. J., Morizet, J., Sainte-Rose, C., Lellouch-Tubiana, A., Kalifa, C., and Gouyette, A. Potent therapeutic activity of irinotecan (CPT-11) and its schedule dependency in medulloblastoma xenografts in nude mice. Int. J. Cancer, 73: 156-163, 1997.
36. Jansen, W. J., Kolfschoten, G. M., Erkelens, C. A., Van Ark-Otte, J., Pinedo, H. M., and Boven, E. Anti-tumor activity of CPT-11 in experimental human ovarian cancer and human soft-tissue sarcoma. Int. J. Cancer, 73: 891-886, 1997.
37. Kawato, Y., Furuta, T., Aonuma, M., Yasuoka, M., Yokokura, T., and Matsumoto, K. Antitumor activity of a camptothecin derivative, CPT-11, against human tumor xenografts in nude mice. Cancer Chemother. Pharmacol., 28: 192-198, 1991.
38. Minderman, H., Cao, S., and Rustman, Y. M. Rational design of irinotecan administration based on preclinical models. Oncology (Huntingt.), 12: 22-30, 1998.
39. Rowinsky, E. K., Grochow, L. B., Ettinger, D. S., Sartorius, S. E., Lubejko, B. G., Chen, T. L., Rock, M. K., and Donehower, R. C. Phase I and pharmacological study of the novel topoisomerase I inhibitor 7-ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxycamptothecin (CPT-11) administered as a ninety-minute infusion every 3 weeks. Cancer Res., 54: 427-436, 1994.
40. Badruddoja, M., Reardon, D., Beason, R., Friedman, A., Quinn, J. A., Rich, J., Sampson, V., Stafford-Fox, D., Bigner, D., and Friedman, H. S. Phase I study of temozolomide plus irinotecan (CPT-11) in adults with recurrent malignant glioma. Proc. Am. Soc. Clin. Oncol., 42: 102a, 2003.
41. Gilbert, M., Wen, P., Lieberman, F., Robins, I., Mehta, M., Yung, W. K. A., Chang, S., Junck, L., Cloughesy, T., and Prados, M. Phase I/II study of combination temozolomide and irinotecan for recurrent malignant glioma: a North American Brain Tumor Consortium study. Proc. Am. Soc. Clin. Oncol., 42: 103a, 2003.
42. Stupp, R., Ostermann, S., Calderoni, A., Uhlmann, C., and Leyvraz, S. Temozolomide and irinotecan for primary brain tumors: a dose escalation study. Proc. Am. Soc. Clin. Oncol., 42: 104a, 2003.
43. Jones, S. F., Gian, V. G., Greco, F. A., Miranda, F. T., Shipley, D. L., Thompson, D. S., Hainsworth, J. D., Toomey, M. A., Willcutt, N. T., and Burris, H. A., III. Phase I trial of irinotecan and temozolomide in patients with solid tumors. Oncology (Huntingt.), 17: 41-45, 2003.
44. Donfrancesco, A., DeSio, L., Milano, G. M., Casstellano, A., Fidani, P., Cozza, R., Illari, I., Dominici, C., and Jenkner, A. Temozolomide in resistant or relapsed pediatric solid tumors: a Phase II study. Proc. Am. Soc. Clin. Oncol., 42: 810a, 2003.
45. 6-Benzylguanine-mediated enhancement of chemotherapy. Mol. Cancer Ther., 1: 943-948, 2002.
46. Houghton, P. J., Stewart, C. F., Thompson, J., Santana, V. M., Furman, W. L., and Friedman, H. S. Extending principles learned in model systems to clinical trials design. Oncology (Huntingt.), 12: 84-93, 1998.