Phase 1 clinical trial of bortezomib in adults with recurrent malignant glioma

Journal of Neuro-Oncology

Volumn 100, Issue 1, 2010, Pages 95-103

  Phuphanich, Surasak ^a   Supko, Jeffrey G ^a   Carson, Kathryn A ^a   Grossman, Stuart A ^a   Burt Nabors, L ^a   Mikkelsen, Tom ^a   Lesser, Glenn ^a   Rosenfeld, Steve ^a   Desideri, Serena ^a   Olson, Jeffrey J ^a  

^a New Approaches to Brain Tumor Therapy CNS Consortium   (United States)

Author keywords

Bortezomib; Cancer; Clinical trials; Malignant gliomas; Pharmacodynamics; Proteasome inhibitors

Indexed keywords

BORTEZOMIB; CARBAMAZEPINE; OXCARBAZEPINE; PHENOBARBITAL; PHENYTOIN; PRIMIDONE;

ABDOMINAL PAIN; ACIDOSIS; ADULT; AGED; ANTINEOPLASTIC ACTIVITY; ARTICLE; CANCER SURVIVAL; CLINICAL TRIAL; CONSCIOUSNESS DISORDER; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DRUG DOSE ESCALATION; DRUG INDUCED HEADACHE; DRUG RESPONSE; ENZYME INHIBITION; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GLIOBLASTOMA; HISTOPATHOLOGY; HUMAN; HYPOKALEMIA; HYPOTENSION; HYPOXIA; INFECTION; KARNOFSKY PERFORMANCE STATUS; MAJOR CLINICAL STUDY; MALE; MAXIMUM TOLERATED DOSE; MULTIPLE CYCLE TREATMENT; NEUTROPHIL COUNT; OLIGODENDROGLIOMA; PETECHIA; PHASE 1 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; PROTHROMBIN TIME; RECURRENT CANCER; SENSORY NEUROPATHY; SIDE EFFECT; THROMBOCYTE COUNT; THROMBOCYTOPENIA;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; BORONIC ACIDS; BRAIN NEOPLASMS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; GLIOMA; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; PROTEASOME ENDOPEPTIDASE COMPLEX; PYRAZINES; TREATMENT OUTCOME;

EID: 79952194923     PISSN: 0167594X     EISSN: 15737373     Source Type: Journal    
DOI: 10.1007/s11060-010-0143-7     Document Type: Article

References (59)

1. Adams J, Palombella VJ, Elliott PJ (2000) Proteasome inhibition: a new strategy in cancer treatment. Invest New Drugs 18:109-121 (Pubitemid 30261285)
2. King RW, Deshaies RJ, Peters JM, Kirschner MW (1996) How proteolysis drives the cell cycle. Science 274:1652-1659 (Pubitemid 26414887)
3. Sherr CJ (1996) Cancer cell cycles. Science 274:1672-1677
4. Read MA, Neish AS, Luscinskas FW, Palombella VJ, Maniatis T, Collins T (1995) The proteasome pathway is required for cytokine-induced endothelial-leukocyte adhesion molecule expression. Immunity 2:493-506
5. Tariman JD (2007) Current therapies for multiple myeloma. J Infus Nurs 30:113-118 quiz 121
6. Sunwoo JB, Chen Z, Dong G et al (2001) Novel proteasome inhibitor PS-341 inhibits activation of nuclear factor-kappa B, cell survival, tumor growth, and angiogenesis in squamous cell carcinoma. Clin Cancer Res 7:1419-1428 (Pubitemid 32708698)
7. Lun M, Zhang PL, Pellitteri PK, Law A, Kennedy TL, Brown RE (2005) Nuclear factor-kappaB pathway as a therapeutic target in head and neck squamous cell carcinoma: Pharmaceutical and molecular validation in human cell lines using velcade and siRNA/ NF-kappaB. Ann Clin Lab Sci 35:251-258 (Pubitemid 41176783)
8. Allen C, Saigal K, Nottingham L, Arun P, Chen Z, Van Waes C (2008) Bortezomib-induced apoptosis with limited clinical response is accompanied by inhibition of canonical but not alternative nuclear factor-{kappa}B subunits in head and neck cancer. Clin Cancer Res 14:4175-4185
9. Frankel A, Man S, Elliott P, Adams J, Kerbel RS (2000) Lack of multicellular drug resistance observed in human ovarian and prostate carcinoma treated with the proteasome inhibitor PS-341. Clin Cancer Res 6:3719-3728
10. Bold RJ, Virudachalam S, McConkey DJ (2001) Chemosensitization of pancreatic cancer by inhibition of the 26S proteasome. J Surg Res 100:11-17 (Pubitemid 32802698)
11. Hideshima T, Richardson P, Chauhan D et al (2001) The proteasome inhibitor PS-341 inhibits growth, induces apoptosis, and overcomes drug resistance in human multiple myeloma cells. Cancer Res 61:3071-3076 (Pubitemid 32691956)
12. LeBlanc R, Catley LP, Hideshima T et al (2002) Proteasome inhibitor PS-341 inhibits human myeloma cell growth in vivo and prolongs survival in a murine model. Cancer Res 62:4996-5000 (Pubitemid 34984425)
13. Mitsiades N, Mitsiades CS, Richardson PG et al (2003) The proteasome inhibitor PS-341 potentiates sensitivity of multiple myeloma cells to conventional chemotherapeutic agents: therapeutic applications. Blood 101:2377-2380 (Pubitemid 36302084)
14. Schenkein D (2002) Proteasome inhibitors in the treatment of B-cell malignancies. Clin Lymphoma 3:49-55
15. Orlowski RZ, Eswara JR, Lafond-Walker A, Grever MR, Orlowski M, Dang CV (1998) Tumor growth inhibition induced in a murine model of human burkitt's lymphoma by a proteasome inhibitor. Cancer Res 58:4342-4348 (Pubitemid 28450035)
16. Giles F (2002) New drugs in acute myeloid leukemia. Curr Oncol Rep 4:369-374
17. Yu C, Rahmani M, Conrad D, Subler M, Dent P, Grant S (2003) The proteasome inhibitor bortezomib interacts synergistically with histone deacetylase inhibitors to induce apoptosis in Bcr/ Abl+ cells sensitive and resistant to STI571. Blood 102:3765-3774 (Pubitemid 37409399)
18. Sayers TJ, Brooks AD, Koh CY et al (2003) The proteasome inhibitor PS-341 sensitizes neoplastic cells to TRAIL-mediated apoptosis by reducing levels of c-FLIP. Blood 102:303-310 (Pubitemid 36759669)
19. Tan C, Waldmann TA (2002) Proteasome inhibitor PS-341, a potential therapeutic agent for adult T-cell leukemia. Cancer Res 62:1083-1086 (Pubitemid 34160291)
20. Richardson PG, Barlogie B, Berenson J et al (2003) A phase 2 study of bortezomib in relapsed, refractory myeloma. N Engl J Med 348:2609-2617 (Pubitemid 36741588)
21. Richardson PG, Barlogie B, Berenson J et al (2005) Clinical factors predictive of outcome with bortezomib in patients with relapsed, refractory multiple myeloma. Blood 106:2977-2981 (Pubitemid 41565888)
22. Jagannath S, Barlogie B, Berenson J et al (2004) A phase 2 study of two doses of bortezomib in relapsed or refractory myeloma. Br J Haematol 127:165-172 (Pubitemid 39371809)
23. Richardson PG, Sonneveld P, Schuster MW et al (2007) Safety and efficacy of bortezomib in high-risk and elderly patients with relapsed multiple myeloma. Br J Haematol 137:429-435 (Pubitemid 46698286)
24. Anderson K, Richardson P, Chanan-Khan A (2006) Single-agent bortezomib in previously untreated multiple myeloma (MM): results of a phase II multicenter study. J Clin Oncol 24(18S):7504
25. Raab MS, Breitkreutz I, Anderson KC (2007) Targeted treatments to improve stem cell outcome: Old and new drugs. Bone Marrow Transplant 40:1129-1137 (Pubitemid 350193804)
26. Strzelczyk J, Safadi R (2004) Radiation safety considerations in GliaSite 125I brain implant procedures. Health Phys 86:S120-S123 (Pubitemid 38509208)
27. Koschny R, Holland H, Sykora J et al (2007) Bortezomib sensitizes primary human astrocytoma cells of WHO grades I to IV for tumor necrosis factor-related apoptosis-inducing ligand-induced apoptosis. Clin Cancer Res 13:3403-3412 (Pubitemid 46944929)
28. Olson JJ, Bowers G, Zhang Z (2004) Protease inhibitors in a brain tumor model. In: Adams J (ed) Cancer drug discovery and development: proteasome inhibitors in cancer therapy. Humana Press Inc, Totowa
29. Zunkeler B, Carson RE, Olson J et al (1996) Quantification and pharmacokinetics of blood-brain barrier disruption in humans. J Neurosurg 85:1056-1065 (Pubitemid 26396559)
30. Glantz MJ, Cole BF, Forsyth PA et al (2000) Practice parameter: anticonvulsant prophylaxis in patients with newly diagnosed brain tumors. Report of the quality standards subcommittee of the American academy of neurology. Neurology 54:1886-1893
31. Vecht CJ, Wagner GL, Wilms EB (2003) Interactions between antiepileptic and chemotherapeutic drugs. Lancet Neurol 2: 404-409 (Pubitemid 36793932)
32. Pekol T, Daniels JS, Labutti J et al (2005) Human metabolism of the proteasome inhibitor bortezomib: identification of circulating metabolites. Drug Metab Dispos 33:771-777 (Pubitemid 40686630)
33. Watling CJ, Lee DH, Macdonald DR, Cairncross JG (1994) Corticosteroid-induced magnetic resonance imaging changes in patients with recurrent malignant glioma. J Clin Oncol 12:1886-1889 (Pubitemid 24349391)
34. Gilbert MR, Supko JG, Batchelor T et al (2003) Phase I clinical and pharmacokinetic study of irinotecan in adults with recurrent malignant glioma. Clin Cancer Res 9:2940-2949 (Pubitemid 37006309)
35. Lightcap ES, McCormack TA, Pien CS, Chau V, Adams J, Elliott PJ (2000) Proteasome inhibition measurements: clinical application. Clin Chem 46:673-683 (Pubitemid 30318423)
36. Aghajanian C, Soignet S, Dizon DS et al (2002) A phase I trial of the novel proteasome inhibitor PS341 in advanced solid tumor malignancies. Clin Cancer Res 8:2505-2511 (Pubitemid 34856332)
37. Orlowski RZ, Stinchcombe TE, Mitchell BS et al (2002) Phase I trial of the proteasome inhibitor PS-341 in patients with refractory hematologic malignancies. J Clin Oncol 20:4420-4427 (Pubitemid 35334752)
38. Papandreou CN, Daliani DD, Nix D et al (2004) Phase I trial of the proteasome inhibitor bortezomib in patients with advanced solid tumors with observations in androgen-independent prostate cancer. J Clin Oncol 22:2108-2121 (Pubitemid 41095144)
39. Cortes J, Thomas D, Koller C et al (2004) Phase I study of bortezomib in refractory or relapsed acute leukemias. Clin Cancer Res 10:3371-3376 (Pubitemid 38685442)
40. Richardson PG, Sonneveld P, Schuster M et al (2007) Extended follow-up of a phase 3 trial in relapsed multiple myeloma: Final time-to-event results of the APEX trial. Blood 110:3557-3560 (Pubitemid 350159621)
41. Fetell MR, Grossman SA, Fisher JD et al (1997) Preirradiation paclitaxel in glioblastoma multiforme: efficacy, pharmacology, and drug interactions. New approaches to brain tumor therapy central nervous system consortium. J Clin Oncol 15:3121-3128
42. Faucette SR, Wang H, Hamilton GA et al (2004) Regulation of CYP2B6 in primary human hepatocytes by prototypical inducers. Drug Metab Dispos 32:348-358 (Pubitemid 38263894)
43. Raucy JL (2003) Regulation of CYP3A4 expression in human hepatocytes by pharmaceuticals and natural products. Drug Metab Dispos 31:533-539
44. Uttamsingh V, Lu C, Miwa G, Gan LS (2005) Relative contributions of the five major human cytochromes P450, 1A2, 2C9, 2C19, 2D6, and 3A4, to the hepatic metabolism of the proteasome inhibitor bortezomib. Drug Metab Dispos 33:1723-1728 (Pubitemid 41539972)
45. Horton TM, Pati D, Plon SE et al (2007) A phase 1 study of the proteasome inhibitor bortezomib in pediatric patients with refractory leukemia: a children's oncology group study. Clin Cancer Res 13:1516-1522 (Pubitemid 46450443)
46. Attar EC, De Angelo DJ, Supko JG et al (2008) Phase I and pharmacokinetic study of bortezomib in combination with idarubicin and cytarabine in patients with acute myelogenous leukemia. Clin Cancer Res 14:1446-1454 (Pubitemid 351413928)
47. Stanford BL, Zondor SD (2003) Bortezomib treatment for multiple myeloma. Ann Pharmacother 37:1825-1830 (Pubitemid 37466582)
48. Davis NB, Taber DA, Ansari RH et al (2004) Phase II trial of PS-341 in patients with renal cell cancer: a university of Chicago phase II consortium study. J Clin Oncol 22:115-119
49. Richardson PG, Briemberg H, Jagannath S et al (2006) Frequency, characteristics, and reversibility of peripheral neuropathy during treatment of advanced multiple myeloma with bortezomib. J Clin Oncol 24:3113-3120 (Pubitemid 46638949)
50. Lonial S, Waller EK, Richardson PG et al (2005) Risk factors and kinetics of thrombocytopenia associated with bortezomib for relapsed, refractory multiple myeloma. Blood 106:3777-3784 (Pubitemid 41739012)
51. Balmaceda C, Peereboom D, Pannullo S, Cheung YK, Fisher PG, Alavi J, Sisti M, Chen J, Fine RL (2008) Multi-institutional phase II study of temozolomide administered twice daily in the treatment of recurrent high-grade gliomas. Cancer 112:1139-1146 (Pubitemid 351304600)
52. Carson KA, Grossman SA, Fisher JD, Shaw EG (2007) Prognostic factors for survival in adult patients with recurrent glioma enrolled onto the new approaches to brain tumor therapy CNS consortium phase I and II clinical trials. J Clin Oncol 25:2601-2606 (Pubitemid 47041234)
53. Wong ET, Hess KR, Gleason MJ et al (1999) Outcomes and prognostic factors in recurrent glioma patients enrolled onto phase II clinical trials. J Clin Oncol 17:2572-2578 (Pubitemid 29368260)
54. Grossman SA, Carson KA, Phuphanich S et al (2008) Phase I and pharmacokinetic study of karenitecin in patients with recurrent malignant gliomas. Neuro Oncol 10:608-616
55. Shapiro WR, Shapiro JR (2006) A changing paradigm of glioma biology. Hematol Oncol Clin North Am 20:1171-1191 (Pubitemid 44739217)
56. Chi A, Norden AD, Wen PY (2007) Inhibition of angiogenesis and invasion in malignant gliomas. Expert Rev Anticancer Ther 7:1537-1560
57. de Groot JF, Gilbert MR (2007) New molecular targets in malignant giomas. Curr Opin Neurol 20:712-718
58. Anderson KC, Jagannath S, Jakubowiak SA, Lonial S, Raje N, Schlossman R, Munshi N, Knight Esseltine RD, Richardson PG (2008) Phase II study to evaluate the efficacy and safety of bortezomib (PS-341) in chemotherapy-naive patients with advanced stage non-small cell lung cancer. J Clin Oncol 26(15S):8545
59. Ho L, Li T, Piperdi B, Macapinlac M, Rigas JR, Camacho F, Perez-Soler R, Gucalp R (2008) Phase II study of lenalidomide, bortezomib, and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma. J Clinc Oncol 26(15S):19096