Pediatric phase I trial and pharmacokinetic study of vorinostat: A children's oncology group phase I consortium report

Journal of Clinical Oncology

Volumn 28, Issue 22, 2010, Pages 3623-3629

  Fouladi, Maryam ^a   Park, Julie R ^a   Stewart, Clinton F ^a   Gilbertson, Richard J ^a   Schaiquevich, Paula ^a   Sun, Junfeng ^a   Reid, Joel M ^a   Ames, Matthew M ^a   Speights, Roseanne ^a   Ingle, Ashish M ^a   Zwiebel, James ^a   Blaney, Susan M ^a   Adamson, Peter C ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

HISTONE; ISOTRETINOIN; VORINOSTAT; ANTINEOPLASTIC AGENT; HYDROXAMIC ACID; RETINOIC ACID;

ACUTE GRANULOCYTIC LEUKEMIA; ACUTE LYMPHOBLASTIC LEUKEMIA; ADOLESCENT; ADULT; AMINOTRANSFERASE BLOOD LEVEL; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; ASTROCYTOMA; ATYPICAL TERATOID RHABDOID TUMOR; CHILD; CHILDHOOD CANCER; CONTROLLED CLINICAL TRIAL; DRUG DISPOSITION; DRUG DOSE ESCALATION; DRUG TOLERABILITY; EPENDYMOMA; EWING SARCOMA; FEMALE; GLIOBLASTOMA; HUMAN; HYPERBILIRUBINEMIA; HYPERTRIGLYCERIDEMIA; HYPOCALCEMIA; HYPOKALEMIA; HYPOMAGNESEMIA; HYPOPHOSPHATEMIA; LEUKEMIA; MAJOR CLINICAL STUDY; MALE; MAXIMUM TOLERATED DOSE; MEDULLOBLASTOMA; NAUSEA; NEUROBLASTOMA; NEUROECTODERM TUMOR; NEUTROPENIA; ONCOLOGY; OSTEOSARCOMA; PEDIATRICS; PERIPHERAL BLOOD MONONUCLEAR CELL; PHASE 1 CLINICAL TRIAL; PINEAL BODY TUMOR; PRESCHOOL CHILD; PRIORITY JOURNAL; PROMYELOCYTIC LEUKEMIA; REFRACTORY ANEMIA; RHABDOID TUMOR; RHABDOMYOSARCOMA; SCHOOL CHILD; SIDE EFFECT; SOFT TISSUE SARCOMA; SOLID TUMOR; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; VOMITING; WESTERN BLOTTING; YOLK SAC TUMOR; CHEMICALLY INDUCED DISORDER; CLINICAL TRIAL; METABOLISM; NEOPLASM; ORAL DRUG ADMINISTRATION;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHILD; CHILD, PRESCHOOL; FEMALE; HUMANS; HYDROXAMIC ACIDS; HYPOKALEMIA; MALE; MAXIMUM TOLERATED DOSE; NEOPLASMS; NEUTROPENIA; THROMBOCYTOPENIA; TRETINOIN;

EID: 77955900071     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2009.25.9119     Document Type: Article

References (30)

1. Marks P, Rifkind R, Richon V, et al: Histone deacetylases and cancer: Causes and therapies. Nature Reviews 1:194-202, 2001 (Pubitemid 33741894)
2. Weidle UH, Grossmann A: Inhibition of histone deacetylases: A new strategy to target epigenetic modifications for anticancer treatment. Anticancer Res 20:1471-1485, 2000 (Pubitemid 30628153)
3. Giles RH, Peters DJ, Breuning MH: Conjunction dysfunction: CBP/p300 in human disease. Trends Genet 14:178-183, 1998 (Pubitemid 28244241)
4. Garcia-Manero G, Yang H, Bueso-Ramos C, et al: Phase 1 study of the histone deacetylase inhibitor vorinostat (suberoylanilide hydroxamic acid [SAHA]) in patients with advanced leukemias and myelodysplastic syndromes. Blood 111:1060-1066, 2008
5. Zhu WG, Dai Z, Ding H, et al: Increased expression of unmethylated CDKN2D by 5-aza-2′-deoxycytidine in human lung cancer cells. Oncogene 20:7787-7796, 2001 (Pubitemid 33121952)
6. Zhu WG, Lakshmanan RR, Beal MD, et al: DNA methyltransferase inhibition enhances apoptosis induced by histone deacetylase inhibitors. Cancer Res 61:1327-1333, 2001 (Pubitemid 34292551)
7. Marks PA: Discovery and development of SAHA as an anticancer agent. Oncogene 26:1351-1356, 2007
8. Johnstone RW: Histone-deacetylase inhibitors: Novel drugs for the treatment of cancer. Nat Rev Drug Discov 1:287-299, 2002
9. Xu WS, Parmigiani RB, Marks PA: Histone deacetylase inhibitors: Molecular mechanisms of action. Oncogene 26:5541-5552, 2007 (Pubitemid 47255934)
10. Keshelava N, Houghton PJ, Morton CL, et al: Initial testing (stage 1) of vorinostat (SAHA) by the pediatric preclinical testing program. Pediatr Blood Cancer 53:505-508, 2009
11. Muhlethaler-Mottet A, Meier R, Flahaut M, et al: Complex molecular mechanisms cooperate to mediate histone deacetylase inhibitors anti-tumour activity in neuroblastoma cells. Mol Cancer 7:55, 2008
12. Deroanne CF, Bonjean K, Servotte S, et al: Histone deacetylases inhibitors as anti-angiogenic agents altering vascular endothelial growth factor signaling. Oncogene 21:427-436, 2002 (Pubitemid 34123805)
13. Zhang G, Park MA, Mitchell C, et al: Vorinostat and sorafenib synergistically kill tumor cells via FLIP suppression and CD95 activation. Clin Cancer Res 14:5385-5399, 2008
14. Cameron EE, Bachman KE, Myohanen S, et al: Synergy of demethylation and histone deacetylase inhibition in the re-expression of genes silenced in cancer. Nat Genet 21:103-107, 1999 (Pubitemid 29036293)
15. Kumagai T, Wakimoto N, Yin D, et al: Histone deacetylase inhibitor, suberoylanilide hydroxamic acid (Vorinostat, SAHA) profoundly inhibits the growth of human pancreatic cancer cells Int J Cancer 121:656-665, 2007
16. Spiller SE, Ditzler SH, Pullar BJ, et al: Response of preclinical medulloblastoma models to combination therapy with 13-cis retinoic acid and suberoylanilide hydroxamic acid (SAHA). J Neurooncol 87:133-141, 2008
17. Yoo CB, Jones PA: Epigenetic therapy of cancer: Past, present and future. Nat Rev Drug Discov 5:37-50, 2006
18. Minucci S, Pelicci PG: Histone deacetylase inhibitors and the promise of epigenetic (and more) treatments for cancer. Nat Rev Cancer 6:38-51, 2006 (Pubitemid 43054973)
19. Duvic M, Talpur R, Ni X, et al: Phase 2 trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) for refractory cutaneous T-cell lymphoma (CTCL). Blood 109:31-39, 2007
20. Olsen EA, Kim YH, Kuzel TM, et al: Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma. J Clin Oncol 25:3109-3115, 2007 (Pubitemid 47218059)
21. Crump M, Coiffier B, Jacobsen ED, et al: Phase II trial of oral vorinostat (suberoylanilide hydroxamic acid) in relapsed diffuse large-B-cell lymphoma. Ann Oncol 19:964-969, 2008 (Pubitemid 351627315)
22. Matthay KK, Villablanca JG, Seeger RC, et al: 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 (Pubitemid 29480654)
23. Therasse P, Arbuck SG, Eisenhauer EA, et al: New guidelines to evaluate the response to treatment in solid tumors: European Organisation for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92:205-216, 2000
24. Anderson BD, Adamson PC, Weiner SL, et al: Tissue collection for correlative studies in childhood cancer clinical trials: Ethical considerations and special imperatives. J Clin Oncol 22:4846-4850, 2004
25. Parise RA, Holleran JL, Beumer JH, et al: A liquid chromatography- electrospray ionization tandem mass spectrometric assay for quantitation of the histone deacetylase inhibitor, vorinostat (suberoylanilide hydroxamicacid, SAHA), and its metabolites in human serum. J Chromatogr B Analyt Technol Biomed Life Sci 840:108-115, 2006 (Pubitemid 44163473)
26. Shah VP, Midha KK, Findlay JW, et al: Bioanalytical method validation-a revisit with a decade of progress. Pharm Res 17:1551-1557, 2000 (Pubitemid 32217566)
27. Fouladi M, Laningham F, Wu J, et al: Phase I study of everolimus in pediatric patients with refractory solid tumors. J Clin Oncol 25:4806-4812, 2007 (Pubitemid 350086485)
28. Kelly WK, O'Connor OA, Krug LM, et al: Phase I study of an oral histone deacetylase inhibitor, suberoylanilide hydroxamic acid, in patients with advanced cancer. J Clin Oncol 23:3923-3931, 2005 (Pubitemid 46218695)
29. Rubin EH, Agrawal NG, Friedman EJ, et al: A study to determine the effects of food and multiple dosing on the pharmacokinetics of vorinostat given orally to patients with advanced cancer. Clin Cancer Res 12:7039-7045, 2006 (Pubitemid 44974501)
30. Ramalingam SS, Parise RA, Ramanathan RK, et al: Phase I and pharmacokinetic study of vorinostat, a histone deacetylase inhibitor, in combination with carboplatin and paclitaxel for advanced solid malignancies. Clin Cancer Res 13:3605-3610, 2007 (Pubitemid 46955122)