Phase I/II intra-patient dose escalation study of vorinostat in children with relapsed solid tumor, lymphoma or leukemia

Klinische Padiatrie

Volumn 224, Issue 6, 2012, Pages 398-403

  Witt, O ^a   Milde, T ^a   Deubzer, H E ^a   Oehme, I ^b   Witt, R ^a   Kulozik, A ^c   Eisenmenger, A ^b   Abel, U ^b   Karapanagiotou Schenkel, I ^b  

^a UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

^b GERMAN CANCER RESEARCH CENTER DKFZ   (Germany)

^c Department of Pediatric Oncology Hematology Immunology and Pneumonology ^*  (Germany)

Author keywords

HDAC; pediatric oncology; phase I II; vorinostat

Indexed keywords

ALANINE AMINOTRANSFERASE; ALBUMIN; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; BONE MORPHOGENETIC PROTEIN 4; CHOLINESTERASE; CREATININE; ELECTROLYTE; GLUCOSE; INTERLEUKIN 10; INTERLEUKIN 6; LACTATE DEHYDROGENASE; VORINOSTAT;

ADOLESCENT; ADULT; ALOPECIA; ANEMIA; ANOREXIA; APPETITE; ARTICLE; CANCER RECURRENCE; CHILD; CHILL; CLINICAL ARTICLE; CONSTIPATION; COUGHING; CREATININE BLOOD LEVEL; CUTANEOUS T CELL LYMPHOMA; DEEP VEIN THROMBOSIS; DIARRHEA; DIZZINESS; DOSE RESPONSE; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DYSGEUSIA; ELECTROLYTE DISTURBANCE; FATIGUE; FEASIBILITY STUDY; FOLLOW UP; GERMANY; HUMAN; HYPERGLYCEMIA; LEUKEMIA; LIVER DISEASE; LUNG EMBOLISM; LYMPHOMA; MAXIMUM TOLERATED DOSE; MULTICENTER STUDY; MUSCLE SPASM; NAUSEA; NEUROBLASTOMA; PERIPHERAL EDEMA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PHYSICAL EXAMINATION; PRESCHOOL CHILD; PRURITUS; QT PROLONGATION; RECOMMENDED DRUG DOSE; SCHOOL CHILD; SIDE EFFECT; THERAPY DELAY; THROMBOCYTOPENIA; TOXICITY; TREATMENT DURATION; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; VOMITING; WEIGHT REDUCTION; XEROSTOMIA;

ADMINISTRATION, ORAL; ADOLESCENT; ANTINEOPLASTIC AGENTS; CHILD; CHILD, PRESCHOOL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HISTONE DEACETYLASE INHIBITORS; HUMANS; HYDROXAMIC ACIDS; LEUKEMIA; LONG-TERM CARE; LYMPHOMA; MALE; NEOPLASM RECURRENCE, LOCAL; NEOPLASMS;

EID: 84869080395     PISSN: 03008630     EISSN: 14393824     Source Type: Journal    
DOI: 10.1055/s-0032-1323692     Document Type: Article

References (37)

1. ZOLINZA (Vorinostat). Food and Drug Administration 2006; http://www.fda.gov/cder/foi/label/2006/021991lbl.pdf
2. Berthold F., Burdach S., Kremens B. et al. The role of chemotherapy in the treatment of children with neuroblastoma stage IV: the GPO (German Pediatric Oncology Society) experience. Klin Padiatr: 1990; 202 262 269 10.1055/s-2007-1025531 (Pubitemid 20219659)
3. Blattmann C., Oertel S., Ehemann V. et al. Enhancement of radiation response in osteosarcoma and rhabdomyosarcoma cell lines by histone deacetylase inhibition. Int J Radiat Oncol Biol Phys: 2010; 78 237 245 10.1016/j.ijrobp. 2010.03.010
4. Brodeur G. M., Pritchard J., Berthold F. et al. Revisions of the international criteria for neuroblastoma diagnosis, staging, and response to treatment. J Clin Oncol: 1993; 11 1466 1477 (Pubitemid 23228250)
5. Creutzig U., Jurgens H., Herold R. et al. Concepts of the Society of Paediatric Oncology and Haematology (GPOH) and the German Competence Network in Paediatric Oncology and Haematology for the quality controlled development in paediatric oncology. Klin Padiatr: 2004; 216 379 383 10.1055/s-2004-832383 (Pubitemid 39524573)
6. Deubzer H., Busche B., Ronndahl G. et al. Novel valproic acid derivatives with potent differentiation-inducing activity in myeloid leukemia cells. Leuk Res: 2006; 30 1167 1175 10.1016/j.leukres.2006.01.009 (Pubitemid 44037087)
7. Deubzer H. E., Ehemann V., Kulozik A. E. et al. Anti-neuroblastoma activity of Helminthosporium carbonum (HC)-toxin is superior to that of other differentiating compounds in vitro. Cancer Lett: 2008; 264 21 28 10.1016/j.canlet.2008.01.002
8. Deubzer H. E., Ehemann V., Westermann F. et al. Histone deacetylase inhibitor Helminthosporium carbonum (HC)-toxin suppresses the malignant phenotype of neuroblastoma cells. Int J Cancer: 2008; 122 1891 1900 10.1002/ijc.23295 (Pubitemid 351413440)
9. Ecke I., Petry F., Rosenberger A. et al. Antitumor effects of a combined 5-aza-2'deoxycytidine and valproic acid treatment on rhabdomyosarcoma and medulloblastoma in Ptch mutant mice. Cancer Res: 2009; 69 887 895 10.1158/0008-5472.CAN-08-0946
10. Einsiedel H. G., Kawan L., Eckert C. et al. Histone deacetylase inhibitors have antitumor activity in two NOD/SCID mouse models of B-cell precursor childhood acute lymphoblastic leukemia. Leukemia: 2006; 20 1435 1436 10.1038/sj.leu.2404282 (Pubitemid 44084058)
11. Fouladi M., Park J. R., Stewart C. F. et al. Pediatric phase I trial and pharmacokinetic study of vorinostat: a Childrens Oncology Group phase I consortium report. J Clin Oncol: 2010; 28 3623 3269 10.1200/JCO.2009.25.9119
12. Fruhwald M. C., Witt O. The epigenetics of cancer in children. Klin Padiatr: 2008; 220 333 341 10.1055/s-0028-1086026
13. Furchert S. E., Lanvers-Kaminsky C., Juurgens H. et al. Inhibitors of histone deacetylases as potential therapeutic tools for high-risk embryonal tumors of the nervous system of childhood. Int J Cancer: 2007; 120 1787 1794 10.1002/ijc.22401 (Pubitemid 46399367)
14. Grunewald TG P., Greulich N., Kontny U., Frühwald M. et al. Targeted Therapeutics in Treatment of Children and Young Adults with Solid Tumors: an Expert Survey and Review of the Literature. Klin Padiatr: 2012; 224 124 131 10.1055/s-0032-1301930
15. Hahn H., Nitzki F., Uhmann A., Ecke I. et al. Hedgehog Signaling: A Therapeutic Target in Embryonal Rhabdomyosarcoma? Klin Padiatr: 2011; 33 47 48
16. Hahnen E., Eyupoglu I. Y., Brichta L. et al. In vitro and ex vivo evaluation of second-generation histone deacetylase inhibitors for the treatment of spinal muscular atrophy. J Neurochem: 2006; 98 193 202 (Pubitemid 43882944)
17. Hockly E., Richon V. M., Woodman B. et al. Suberoylanilide hydroxamic acid, a histone deacetylase inhibitor, ameliorates motor deficits in a mouse model of Huntingtons disease. Proc Natl Acad Sci USA: 2003; 100 2041 2046 (Pubitemid 36254570)
18. Kelly W. K., OConnor O. A., Krug L. M. et al. Phase I study of an oral histone deacetylase inhibitor, suberoylanilide hydroxamic acid, in patients with advanced cancer. J Clin Oncol: 2005; 23 3923 3931 10.1200/JCO.2005.14.167 (Pubitemid 46218695)
19. Kelly W. K., Richon V. M., OConnor O. et al. Phase I clinical trial of histone deacetylase inhibitor: suberoylanilide hydroxamic acid administered intravenously. Clin Cancer Res: 2003; 9 3578 3588 (Pubitemid 37169221)
20. Kruchen AJ PD, Handgretinger R., Mueller I. I. Effect of the HDAC inhibitor SAHA on the immunomodulatory properties of MSC and tumor stroma cells. Klin Padiatr: 2010; 03 A50 10.1055/s-0030-1254501
21. Kuhl J. A study group on brain tumors in childhood. Introduction, establishment and aims. Klin Padiatr: 1987; 199 196 199 10.1055/s-2008-1026789 (Pubitemid 17079859)
22. Kumar K. S., Sonnemann J., Beck J. F. Histone deacetylase inhibitors induce cell death in supratentorial primitive neuroectodermal tumor cells. Oncol Rep: 2006; 16 1047 1052
23. Kumar K. S., Sonnemann J., Hong le T. T. et al. Histone deacetylase inhibitors, but not vincristine, cooperate with radiotherapy to induce cell death in medulloblastoma. Anticancer Res: 2007; 27 465 470 (Pubitemid 46363367)
24. Milde T., Kleber S., Korshunov A. et al. A novel human high-risk ependymoma stem cell model reveals the differentiation-inducing potential of the histone deacetylase inhibitor Vorinostat. Acta neuropathologica: 2011; 122 637 650 10.1007/s00401-011-0866-3
25. Milde T., Oehme I., Korshunov A. et al. HDAC5 and HDAC9 in medulloblastoma: novel markers for risk stratification and role in tumor cell growth. Clin Cancer Res: 2010; 16 3240 3252 10.1158/1078-0432.CCR-10-0395
26. Minucci S., Pelicci P. G. Histone deacetylase inhibitors and the promise of epigenetic (and more) treatments for cancer. Nat Rev Cancer: 2006; 6 38 51 (Pubitemid 43054973)
27. Oehme I., Deubzer H. E., Lodrini M. et al. Targeting of HDAC8 and investigational inhibitors in neuroblastoma. Expert Opin Investig Drugs: 2009; 18 1605 1617 10.1517/14728220903241658
28. Oehme I., Deubzer H. E., Wegener D. et al. Histone deacetylase 8 in neuroblastoma tumorigenesis. Clin Cancer Res: 2009; 15 91 99 10.1158/1078-0432.CCR-08-0684
29. Padhani A. R., Ollivier L. The RECIST (Response Evaluation Criteria in Solid Tumors) criteria: implications for diagnostic radiologists. Br J Radiol: 2001; 74 983 986 (Pubitemid 33121128)
30. Schäfer B. Therapeutic Strategies Targeting Oncogenic Fusion Proteins in Sarcomas. Klin Padiatr: 2011; 01 A11 10.1055/s-0030-1270304
31. Sonnemann J., Kumar K. S., Heesch S. et al. Histone deacetylase inhibitors induce cell death and enhance the susceptibility to ionizing radiation, etoposide, and TRAIL in medulloblastoma cells. Int J Oncol: 2006; 28 755 766
32. Therasse P., Arbuck S. G., Eisenhauer E. A. et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst: 2000; 92 205 216
33. Wegener D., Deubzer H. E., Oehme I. et al. HKI 46F08, a novel potent histone deacetylase inhibitor, exhibits antitumoral activity against embryonic childhood cancer cells. Anticancer Drugs: 2008; 19 849 857 10.1097/CAD. 0b013e32830efbeb
34. Witt O., Deubzer H. E., Lodrini M. et al. Targeting histone deacetylases in neuroblastoma. Current pharmaceutical design: 2009; 15 436 447
35. Witt O., Deubzer H. E., Milde T. et al. HDAC family: What are the cancer relevant targets? Cancer Lett: 2009; 277 8 21 10.1016/j.canlet.2008.08.016
36. Witt O., Monkemeyer S., Ronndahl G. et al. Induction of fetal hemoglobin expression by the histone deacetylase inhibitor apicidin. Blood: 2003; 101 2001 2007 (Pubitemid 36237607)
37. Witt O., Schweigerer L., Driever P. H. et al. Valproic acid treatment of glioblastoma multiforme in a child. Pediatr Blood Cancer: 2004; 43 181 (Pubitemid 38891170)