A phase I/II trial of the histone deacetylase inhibitor romidepsin for adults with recurrent malignant glioma: North American brain tumor consortium study 03-03

Neuro-Oncology

Volumn 13, Issue 5, 2011, Pages 509-516

  Iwamoto, Fabio M ^a   Lamborn, Kathleen R ^b   Kuhn, John G ^c   Wen, Patrick Y ^e   Alfred Yung, W K ^d   Gilbert, Mark R ^d   Chang, Susan M ^b   Lieberman, Frank S ^f   Prados, Michael D ^b   Fine, Howard A ^a  

^a NATIONAL CANCER INSTITUTE   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^d UNIVERSITY OF TEXAS   (United States)

^e DANA FARBER CANCER INSTITUTE   (United States)

^f UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

Author keywords

Glioblastoma; Glioma; Histone deacetylase inhibitor; Romidepsin

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ANTIEMETIC AGENT; ASPARTATE AMINOTRANSFERASE; CYTOCHROME P450 3A4; ROMIDEPSIN;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CANCER CHEMOTHERAPY; CANCER MORTALITY; CANCER PATIENT; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CHILL; CLINICAL ARTICLE; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG METABOLISM; DRUG RESPONSE; DRUG WITHDRAWAL; FATIGUE; FEMALE; GAIT DISORDER; GLIOBLASTOMA; HOT FLUSH; HUMAN; HYPERGLYCEMIA; HYPOGLYCEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; LEUKOPENIA; LYMPHOCYTOPENIA; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; RECURRENT CANCER; RIGOR; SIDE EFFECT; STEADY STATE; SURVIVAL TIME; THROMBOCYTOPENIA; WALKING DIFFICULTY;

ADULT; AGED; ANTIBIOTICS, ANTINEOPLASTIC; BRAIN NEOPLASMS; DEPSIPEPTIDES; FEMALE; FOLLOW-UP STUDIES; GLIOMA; HISTONE DEACETYLASE INHIBITORS; HUMANS; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; SURVIVAL RATE; TISSUE DISTRIBUTION; TREATMENT OUTCOME;

EID: 79959956310     PISSN: 15228517     EISSN: 15235866     Source Type: Journal    
DOI: 10.1093/neuonc/nor017     Document Type: Article

References (29)

1. Wen PY, Kesari S. Malignant gliomas in adults. N Engl J Med 2008;359:492-507.
2. Wu W, Lamborn KR, Buckner JC, et al. Joint NCCTG and NABTC prognostic factors analysis for high-grade recurrent glioma. Neuro Oncol 2010;12:164-172.
3. Brem H, Piantadosi S, Burger PC, et al. Placebo-controlled trial of safety and efficacy of intraoperative controlled delivery by biodegradable polymers of chemotherapy for recurrent gliomas. The Polymer-brain Tumor Treatment Group. Lancet 1995;345:1008-1012.
4. Kreisl TN, Kim L, Moore K, et al. Phase II trial of single-agent bevacizumab followed by bevacizumab plus irinotecan at tumor progression in recurrent glioblastoma. J Clin Oncol 2009;27:740-745.
5. Friedman HS, Prados MD, Wen PY, et al. Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. J Clin Oncol 2009;27:4733-4740.
6. Bolden JE, Peart MJ, Johnstone RW. Anticancer activities of histone deacetylase inhibitors. Nat Rev Drug Discov 2006;5:769-784. (Pubitemid 44348499)
7. Lee JH, Choy ML, Ngo L, Foster SS, Marks PA. Histone deacetylase inhibitor induces DNA damage, which normal but not transformed cells can repair. Proc Natl Acad Sci U S A 2010;107:14639-14644.
8. Yu X, Guo ZS, Marcu MG, et al. Modulation of p53, ErbB1, ErbB2, and Raf-1 expression in lung cancer cells by depsipeptide FR901228. J Natl Cancer Inst 2002;94:504-513. (Pubitemid 34411289)
9. Sun P, Xia S, Lal B, et al. DNER, an epigenetically modulated gene, regulates glioblastoma-derived neurosphere cell differentiation and tumor propagation. Stem Cells 2009;27:1473-1486.
10. Furumai R, Matsuyama A, Kobashi N, et al. FK228 (depsipeptide) as a natural prodrug that inhibits class I histone deacetylases. Cancer Res 2002;62:4916-4921. (Pubitemid 34984414)
11. Sawa H, Murakami H, Kumagai M, et al. Histone deacetylase inhibitor, FK228, induces apoptosis and suppresses cell proliferation of human glioblastoma cells in vitro and in vivo. Acta Neuropathol 2004;107:523-531. (Pubitemid 38765394)
12. Piekarz RL, Frye R, Turner M, et al. Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T-cell lymphoma. J Clin Oncol 2009;27:5410-5417.
13. Whittaker SJ, Demierre MF, Kim EJ, et al. Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma. J Clin Oncol 2010;28:4730-4739.
14. Shiraga T, Tozuka Z, Ishimura R, Kawamura A, Kagayama A. Identification of cytochrome P450 enzymes involved in the metabolism of FK228, a potent histone deacetylase inhibitor, in human liver microsomes. Biol Pharm Bull 2005;28:124-129. (Pubitemid 40879796)
15. Macdonald DR, Cascino TL, Schold SC, Jr, Cairncross JG. Response criteria for phase II studies of supratentorial malignant glioma. J Clin Oncol 1990;8:1277-1280. (Pubitemid 20195640)
16. Chassaing C, Marshall JL, Wainer IW. Determination of the antitumor agent depsipeptide in plasma by liquid chromatography on serial octadecyl stationary phases. J Chromatogr B Biomed Sci Appl 1998;719:169-176.
17. Wong ET, Hess KR, Gleason MJ, et al. Outcomes and prognostic factors in recurrent glioma patients enrolled onto phase II clinical trials. J Clin Oncol 1999;17:2572-2578. (Pubitemid 29368260)
18. Klimek VM, Fircanis S, Maslak P, et al. Tolerability, pharmacodynamics, and pharmacokinetics studies of depsipeptide (romidepsin) in patients with acute myelogenous leukemia or advanced myelodysplastic syndromes. Clin Cancer Res 2008;14:826-832. (Pubitemid 351231166)
19. Byrd JC, Marcucci G, Parthun MR, et al. A phase 1 and pharmacodynamic study of depsipeptide (FK228) in chronic lymphocytic leukemia and acute myeloid leukemia. Blood 2005;105:959-967. (Pubitemid 40170861)
20. Sandor V, Bakke S, Robey RW, et al. Phase I trial of the histone deacetylase inhibitor, depsipeptide (FR901228, NSC 630176), in patients with refractory neoplasms. Clin Cancer Res 2002;8:718-728. (Pubitemid 34742100)
21. Fouladi M, Furman WL, Chin T, et al. Phase I study of depsipeptide in pediatric patients with refractory solid tumors: a Children's Oncology Group report. J Clin Oncol 2006;24:3678-3685. (Pubitemid 46630544)
22. Lin JH, Lu AY. Inhibition and induction of cytochrome P450 and the clinical implications. Clin Pharmacokinet 1998;35:361-390. (Pubitemid 28520008)
23. Woo S, Gardner ER, Chen X, et al. Population pharmacokinetics of romidepsin in patients with cutaneous T-cell lymphoma and relapsed peripheral T-cell lymphoma. Clin Cancer Res 2009;15:1496-1503.
24. Shah MH, Binkley P, Chan K, et al. Cardiotoxicity of histone deacetylase inhibitor depsipeptide in patients with metastatic neuroendocrine tumors. Clin Cancer Res 2006;12:3997-4003. (Pubitemid 44078086)
25. Lamborn KR, Yung WK, Chang SM, et al. Progression-free survival: an important end point in evaluating therapy for recurrent high-grade gliomas. Neuro Oncol 2008;10:162-170.
26. Berg SL, Stone J, Xiao JJ, et al. Plasma and cerebrospinal fluid pharmacokinetics of depsipeptide (FR901228) in nonhuman primates. Cancer Chemother Pharmacol 2004;54:85-88. (Pubitemid 38858370)
27. Calatozzolo C, Gelati M, Ciusani E, et al. Expression of drug resistance proteins Pgp, MRP1, MRP3, MRP5 and GST-pi in human glioma. J Neurooncol 2005;74:113-121. (Pubitemid 41478906)
28. Choudhary C, Kumar C, Gnad F, et al. Lysine acetylation targets protein complexes and co-regulates major cellular functions. Science 2009;325:834-840.
29. Peart MJ, Smyth GK, van Laar RK, et al. Identification and functional significance of genes regulated by structurally different histone deacetylase inhibitors. Proc Natl Acad Sci U S A 2005;102:3697-3702. (Pubitemid 40354674)