Phase I and pharmacokinetic study of thalidomide with carboplatin in children with cancer

Journal of Clinical Oncology

Volumn 22, Issue 21, 2004, Pages 4394-4400

  Chintagumpala, Murali ^a   Blaney, Susan M ^a   Bomgaars, Lisa R ^a   Aleksic, Aleksander ^a   Kuttesch, John F ^a   Klenke, Renee A ^a   Berg, Stacey L ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; THALIDOMIDE; ANTINEOPLASTIC AGENT;

AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONCENTRATION RESPONSE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE TIME EFFECT RELATION; DRUG CLEARANCE; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; HOSPITAL PATIENT; HUMAN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SOLID TUMOR; SOMNOLENCE; ADOLESCENT; ADULT; CHILD; DOSE RESPONSE; FEMALE; INFANT; MALE; NEOPLASM; PRESCHOOL CHILD; TREATMENT OUTCOME;

ADOLESCENT; ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AREA UNDER CURVE; CARBOPLATIN; CHILD; CHILD, PRESCHOOL; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; INFANT; MALE; NEOPLASMS; THALIDOMIDE; TREATMENT OUTCOME;

EID: 16444387653     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2004.04.565     Document Type: Article

References (50)

1. Folkman J: Tumor angiogenesis, in Holland JF, Frei E III (eds): Cancer Medicine. Philadelphia. Lea & Febiger, 1993, pp 153-170
2. Kim K, Winer J, Armani M, et al: Inhibition of vascular endothelial growth factor-induced angiogenesis suppresses tumour growth in vivo. Nature 362:841-844, 1993
3. Kamei S, Okada H, Inoue Y, et al: Antitumor effects of angiogensis inhibitor TNP-470 in rabbits bearing VX-2 carcinoma by arterial administration of microspheres and oil solution. J Pharmacol Exp Ther 264:469-474, 1993
4. Weidner N, Carrol P, Flax J, et al: Tumor angiogenesis correlates with metastasis in invasive prostate carcinoma. Am J Pathol 143:401-409, 1993
5. Weidner N, Semple J, Welch W, et al: Tumor angiogenesis and metastasis-correlation in invasive breast carcinoma. N Engl J Med 324:1-8, 1991
6. D'Amato R, Loughnan M, Flynn E, et al: Thalidomide is an inhibitor of angiogenesis. Proc Natl Acad Sci U S A 91:4082-4085, 1994
7. Meierhofer C, Wiedermann CJ: New insights into the pharmacological and toxicological effects of thalidomide. Curr Opin Drug Discov Devel 6:92-99, 2003
8. Glass J, Gruber M, Nirenberg A: Phase I/II study of carboplatin and thalidomide in recurrent glioblastoma multiforme. Proc Am Soc Clin Oncol 18:551, 1999
9. Marina N, Rodman J, Shema S, et al: Phase I study of escalating targeted doses of carboplatin combined with ifosfamide and etoposide in children with relapsed solid tumors. J Clin Oncol 11:554-560, 1993
10. Politi P, Reboredo G, Losso M, et al: Phase I trial of thalidomide in AIDS-related Kaposi's sarcoma. Proc Am Soc Clin Oncol 17:41a, 1998 (abstr A161)
11. Serabe B, Adamson P, Wolfe R, et al: Phase I trial and pharmacokinetic study of phenylacetate given as a 28-day continuous infusion. Proc Am Assoc Cancer Res 38:224, 1997 (abstr 1507)
12. Simmons B, Lush R, Figg W: A reversed-phase high performance liquid chromatography method using solid phase extraction to quantitate thalidomide in human serum. Anal Chim Acta 339:91-97, 1997
13. D'Argenio D, Schumitzky A: ADAPT II User's Guide: Pharmacokinetic/ Pharmacodynamic Systems Analysis Software. Los Angeles, Biomedical Simulations Resource, 1997
14. Yamaoka K, Nakagawa T, Uno T: Application of Akaike's information criterion (AIC) in the evaluation of linear pharmacokinetic equations. J Pharmacokinet Biopharm 6:165-175, 1978
15. Gibaldi M, Perrier D: Pharmacokinetics (ed 2nd). New York and Basel, Marcel Dekker Inc, 1982
16. Jacobson J, Greenspan J, Spritzler J. et al: Thalidomide for the treatment of oral aphthous ulcers in patients with human immunodeficiency virus. N Engl J Med 336:1487-1493, 1997
17. Haslett P, Tramontana J, Burroughs M, et al: Adverse reactions to thalidomide in patients infected with Human Immunodeficiency Virus. Clin Infect Dis 24:1223-1227, 1997
18. Minnema MC, Fijnheer R, De Groot PG, et al: Extremely high levels of von Willebrand factor antigen and of procoagulant factor VIII found in multiple myeloma patients are associated with activity status but not with thalidomide treatment. J Thromb Haemost 1:445-449, 2003
19. Zangari M, Barlogie B, Thertulien R, et al: Thalidomide and deep vein thrombosis in multiple myeloma: Risk factors and effect on survival. Clin Lymphoma 4:32-35, 2003
20. Badros AZ, Siegel E, Bodenner D, et al: Hypothyroidism in patients with multiple myeloma following treatment with thalidomide. Am J Med 112:412-413, 2002
21. Figg A, Bergan R, Brawley O, et al: Randomized phase II study of thalidomide in androgen-independent prostate cancer. Proc Am Soc Clin Oncol 16:333a, 1997 (abstr A1189)
22. Fine H, Loeffler J, Kyritsis A, et al: A Phase II trial of the antiangiogenic agent thalidomide in patients with recurrent high-grade gliomas. Proc Am Soc Clin Oncol 16:385a, 1997 (abstr 1372)
23. Cole C, Rogers P, Pritchard S, et al: Thalidomide in the management of chronic graft versus host disease in children following bone marrow transplantation. Bone Marrow Transplant 14:937-942, 1994
24. Rovelli A, Arrigo C, Nesi F. et al: The role of thalidomide in the treatment of refractory chronic graft versus host disease following bone marrow transplantation in children. Bone Marrow Transplant 21:577-581, 1998
25. Chen T-L, Vogelsange G, Petty B, et al: Plasma pharmacokinetics and urinary excretion of thalidomide after oral dosing in healthy male volunteers. Drug Metab Dispos 17:402-405, 1989
26. Piscitelli SC, Figg WD, Hahn B, et al: Single-dose pharmacokinetics of thalidomide in human immunodeficiency virus-infected patients. Antimicrob Agents Chemother 41:2797-2799, 1997
27. Figg WD, Raje S, Bauer KS, et al: Pharmacokinetics of thalidomide in an elderly prostate cancer population. J Pharm Sci 88:121-125, 1999
28. Noormohamed FH, Youle MS, Higgs CJ, et al: Pharmacokinetics and hemodynamic effects of single oral doses of thalidomide in asymptomatic human immunodeficiency virus-infected subjects. AIDS Res Hum Retroviruses 15:1047-1052, 1999
29. Aweeka F, Trapnell C, Chernoff M, et al: Pharmacokinetics and pharmacodynamics of thalidomide in HIV patients treated for oral aphthous ulcers: ACTG protocol 251-AIDS Clinical Trials Group. J Clin Pharmacol 41:1091-1097, 2001
30. Ando Y, Price DK, Dahut WL, et al: Pharmacogenetic associations of CYP2C19 genotype with in vivo metabolisms and pharmacological effects of thalidomide. Cancer Biol Ther 1:669-673, 2002
31. Goldstein JA: Clinical relevance of genetic polymorphisms in the human CYP2C subfamily. Br J Clin Pharmacol 52:349-355, 2001
32. Koukouritaki SB, Manro JR, Marsh SA, et al: Developmental Expression of Human Hepatic CYP2C9 and CYP2C19. J Pharmacol Exp Ther 308:965-974, 2003
33. Lim S, McWhannell A, Vora A, et al: Successful treatment with thalidomide of acute graft-versus-host disease after bone marrow transplantation. Lancet 1:117, 1988
34. McCarthy D, Kanfer E, Taylor J: Thalidomide for graft-versus-host disease a. Lancet 2:1135, 1988
35. Vogelsang G, Hess A, Gordon G, et al: Thalidomide induction of bone marrow transplantation tolerance. Transplant Proc 19:2658-2661, 1987
36. Sheskin J: The treatment of lepra reaction in lepromatous leprosy: Fifteen years' experience with thalidomide. lnt J Dermatol 19:318-322, 1980
37. Gardner-Medwin J, Smith N, Powell R: Clinical experience with thalidomide in the management of severe oral and genital ulceration in conditions such as Behcet's disease: Use of neurophysiological studies to detect thalidomide neuropathy. Ann Rheum Dis 53:828-832, 1994
38. Haslett P, Hempstead M, Seidman C, et al: The metabolic and immunologic effcts of short-term thalidomide treatment of patients infected with the Human Immunodeficiency Virus. AIDS Res Hum Retroviruses 13:1047-1054, 1997
39. Figg WD, Arlen P, Gulley J, et al: A randomized phase II trial of docetaxel (taxotere) plus thalidomide in androgen-independent prostate cancer. Semin Oncol 28:62-66, 2001
40. Figg WD, Dahut W, Duray P, et al: A randomized phase II trial of thalidomide, an angiogenesis inhibitor, in patients with androgen-independent prostate cancer. Clin Cancer Res 7:1888-1893, 2001
41. Marx GM, Pavlakis N, McCowatt S, et al: Phase II study of thalidomide in the treatment of recurrent glioblastoma multiforme. J Neurooncol 54:31-38, 2001
42. Motzer RJ, Berg W, Ginsberg M, et al: Phase II trial of thalidomide for patients with advanced renal cell carcinoma. J Clin Oncol 20:302-306, 2002
43. Soni S, Lee DS, DiVito J Jr., et al: Treatment of pediatric ocular melanoma with high-dose interleukin-2 and thalidomide. J Pediatr Hematol Oncol 24:488-491, 2002
44. Tseng JE, Glisson BS, Khuri FR, et al: Phase II study of the antiangiogenesis agent thalidomide in recurrent or metastatic squamous cell carcinoma of the head and neck. Cancer 92:2364-2373, 2001
45. Wechalekar AD, Chen CI, Sutton D, et al: Intermediate dose thalidomide (200 mg daily) has comparable efficacy and less toxicity than higher doses in relapsed multiple myeloma. Leuk Lymphoma 44:1147-1149, 2003
46. Dan K: Thalidomide as a targeted therapy for multiple myeloma. Intern Med 42:550-551, 2003
47. Anagnostopoulos A, Weber D, Rankin K, et al: Thalidomide and dexamethasone for resistant multiple myeloma. Br J Haematol 121:768-771, 2003
48. Ribas C, Colleoni GW: Advances in the treatment of multiple myeloma: The role of thalidomide. Leuk Lymphoma 44:291-298, 2003
49. Mileshkin L, Biagi JJ, Mitchell P, et al: Multicenter phase 2 trial of thalidomide in relapsed/refractory multiple myeloma: Adverse prognostic impact of advanced age. Blood 102: 69-77, 2003
50. Weber D, Rankin K, Gavino M, et al: Thalidomide alone or with dexamethasone for previously untreated multiple myeloma. J Clin Oncol 21:16-19, 2003