A phase I trial of carboplatin administered by convection-enhanced delivery to patients with recurrent/progressive glioblastoma multiforme

Contemporary Clinical Trials

Volumn 33, Issue 2, 2012, Pages 320-331

  White, Edward ^a,b   Bienemann, Alison ^b   Taylor, Hannah ^b   Hopkins, Kirsten ^c   Cameron, Alison ^c   Gill, Steven ^a,b  

^a FRENCHAY HOSPITAL   (United Kingdom)

^b UNIVERSITY OF BRISTOL   (United Kingdom)

^c BRISTOL HAEMATOLOGY AND ONCOLOGY CENTRE   (United Kingdom)

Author keywords

Carboplatin; Convection enhanced delivery; Glioblastoma multiforme

Indexed keywords

CARBOPLATIN;

ADULT; ARTICLE; BLOOD BRAIN BARRIER; CANCER SURGERY; CLINICAL ARTICLE; CONVECTION ENHANCED DELIVERY; DISEASE COURSE; DRUG DELIVERY SYSTEM; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GLIOBLASTOMA; HUMAN; MALE; MAXIMUM TOLERATED DOSE; PHASE 1 CLINICAL TRIAL; RECURRENT DISEASE; THERMODYNAMICS;

ADULT; ANTINEOPLASTIC AGENTS; BLOOD-BRAIN BARRIER; BRAIN NEOPLASMS; CARBOPLATIN; DISEASE PROGRESSION; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG DELIVERY SYSTEMS; FEMALE; FOLLOW-UP STUDIES; GLIOBLASTOMA; HUMANS; MALE; NEOPLASM RECURRENCE, LOCAL; TREATMENT OUTCOME;

EID: 84856234252     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2011.10.010     Document Type: Article

References (61)

1. Deorah S., Lynch C.F., Sibenaller Z.A., Ryken T.C. Trends in brain cancer incidence and survival in the United States: surveillance, epidemiology, and end results program, 1973 to 2001. Neurosurg Focus 2006, 20:E1.
2. Bleehen N.M., Stenning S.P. A Medical Research Council trial of two radiotherapy doses in the treatment of grades 3 and 4 astrocytoma. The Medical Research Council Brain Tumour Working Party. Br J Cancer 1991, 64:769-774.
3. Wallner K.E., Galicich J.H., Krol G., Arbit E., Malkin M.G. Patterns of failure following treatment for glioblastoma multiforme and anaplastic astrocytoma. Int J Radiat Oncol Biol Phys 1989, 16:1405-1409.
4. Chemotherapy for high-grade glioma. Cochrane Database Syst Rev 2002, CD003913.
5. Westphal M., Hilt D.C., Bortey E., Delavault P., Olivares R., Warnke P.C., et al. A phase 3 trial of local chemotherapy with biodegradable carmustine (BCNU) wafers (Gliadel wafers) in patients with primary malignant glioma. Neuro Oncol 2003, 5:79-88.
6. Lidar Z., Mardor Y., Jonas T., Pfeffer R., Faibel M., Nass D., et al. Convection-enhanced delivery of paclitaxel for the treatment of recurrent malignant glioma: a phase I/II clinical study. J Neurosurg 2004, 100:472-479.
7. Grahn A.Y., Bankiewicz K.S., Dugich-Djordjevic M., Bringas J.R., Hadaczek P., Johnson G.A., et al. Non-PEGylated liposomes for convection-enhanced delivery of topotecan and gadodiamide in malignant glioma: initial experience. J Neurooncol 2009, 95:185-197.
8. Chiocca E.A., Abbed K.M., Tatter S., Louis D.N., Hochberg F.H., Barker F., et al. A phase I open-label, dose-escalation, multi-institutional trial of injection with an E1B-attenuated adenovirus, ONYX-015, into the peritumoral region of recurrent malignant gliomas, in the adjuvant setting. Mol Ther 2004, 10:958-966.
9. Harrow S., Papanastassiou V., Harland J., Mabbs R., Petty R., Fraser M., et al. HSV1716 injection into the brain adjacent to tumour following surgical resection of high-grade glioma: safety data and long-term survival. Gene Ther 2004, 11:1648-1658.
10. Markert J.M., Medlock M.D., Rabkin S.D., Gillespie G.Y., Todo T., Hunter W.D., et al. Conditionally replicating herpes simplex virus mutant, G207 for the treatment of malignant glioma: results of a phase I trial. Gene Ther 2000, 7:867-874.
11. Papanastassiou V., Rampling R., Fraser M., Petty R., Hadley D., Nicoll J., et al. The potential for efficacy of the modified (ICP 34.5(-)) herpes simplex virus HSV1716 following intratumoural injection into human malignant glioma: a proof of principle study. Gene Ther 2002, 9:398-406.
12. Rampling R., Cruickshank G., Papanastassiou V., Nicoll J., Hadley D., Brennan D., et al. Toxicity evaluation of replication-competent herpes simplex virus (ICP 34.5 null mutant 1716) in patients with recurrent malignant glioma. Gene Ther 2000, 7:859-866.
13. Chiocca E.A., Smith K.M., McKinney B., Palmer C.A., Rosenfeld S., Lillehei K., et al. A phase I trial of Ad.hIFN-beta gene therapy for glioma. Mol Ther 2008, 16:618-626.
14. Lang F.F., Bruner J.M., Fuller G.N., Aldape K., Prados M.D., Chang S., et al. Phase I trial of adenovirus-mediated p53 gene therapy for recurrent glioma: biological and clinical results. J Clin Oncol 2003, 21:2508-2518.
15. Rainov N.G. A phase III clinical evaluation of herpes simplex virus type 1 thymidine kinase and ganciclovir gene therapy as an adjuvant to surgical resection and radiation in adults with previously untreated glioblastoma multiforme. Hum Gene Ther 2000, 11:2389-2401.
16. Yoshida J., Mizuno M., Fujii M., Kajita Y., Nakahara N., Hatano M., et al. Human gene therapy for malignant gliomas (glioblastoma multiforme and anaplastic astrocytoma) by in vivo transduction with human interferon beta gene using cationic liposomes. Hum Gene Ther 2004, 15:77-86.
17. Kunwar S., Chang S., Westphal M., Vogelbaum M., Sampson J., Barnett G., et al. Phase III randomized trial of CED of IL13-PE38QQR vs Gliadel wafers for recurrent glioblastoma. Neuro Oncol 2010, 12(8):871-881.
18. Hart M.G., Grant R., Garside R., Rogers G., Somerville M., Stein K. Chemotherapeutic wafers for high grade glioma. Cochrane Database Syst Rev 2008, CD007294.
19. Fleming A.B., Saltzman W.M. Pharmacokinetics of the carmustine implant. Clin Pharmacokinet 2002, 41:403-419.
20. Giese A., Kucinski T., Knopp U., Goldbrunner R., Hamel W., Mehdorn H.M., et al. Pattern of recurrence following local chemotherapy with biodegradable carmustine (BCNU) implants in patients with glioblastoma. J Neurooncol 2004, 66:351-360.
21. Chen M.Y., Lonser R.R., Morrison P.F., Governale L.S., Oldfield E.H. Variables affecting convection-enhanced delivery to the striatum: a systematic examination of rate of infusion, cannula size, infusate concentration, and tissue-cannula sealing time. J Neurosurg 1999, 90:315-320.
22. Bobo R.H., Laske D.W., Akbasak A., Morrison P.F., Dedrick R.L., Oldfield E.H. Convection-enhanced delivery of macromolecules in the brain. Proc Natl Acad Sci U S A 1994, 91:2076-2080.
23. Sampson J.H., Raghavan R., Brady M.L., Provenzale J.M., Herndon J.E., Croteau D., et al. Clinical utility of a patient-specific algorithm for simulating intracerebral drug infusions. Neuro Oncol 2007, 9:343-353.
24. Wolff J.E., Trilling T., Molenkamp G., Egeler R.M., Jurgens H. Chemosensitivity of glioma cells in vitro: a meta analysis. J Cancer Res Clin Oncol 1999, 125:481-486.
25. Gruber M.L., Glass J., Choudhri H., Nirenberg A. Carboplatin chemotherapy before irradiation in newly diagnosed glioblastoma multiforme. Am J Clin Oncol 1998, 21:338-340.
26. Prados M.D., Warnick R.E., Mack E.E., Chandler K.L., Rabbitt J., Page M., et al. Intravenous carboplatin for recurrent gliomas. A dose-escalating phase II trial. Am J Clin Oncol 1996, 19:609-612.
27. de Groot J.F., Gilbert M.R., Aldape K., Hess K.R., Hanna T.A., Ictech S., et al. Phase II study of carboplatin and erlotinib (Tarceva, OSI-774) in patients with recurrent glioblastoma. J Neurooncol 2008, 90:89-97.
28. Tang P., Roldan G., Brasher P.M., Fulton D., Roa W., Murtha A., et al. A phase II study of carboplatin and chronic high-dose tamoxifen in patients with recurrent malignant glioma. J Neurooncol 2006, 78:311-316.
29. Limentani S.A., Asher A., Heafner M., Kim J.W., Fraser R. A phase I trial of surgery, Gliadel wafer implantation, and immediate postoperative carboplatin in combination with radiation therapy for primary anaplastic astrocytoma or glioblastoma multiforme. J Neurooncol 2005, 72:241-244.
30. Franceschi E., Cavallo G., Scopece L., Paioli A., Pession A., Magrini E., et al. Phase II trial of carboplatin and etoposide for patients with recurrent high-grade glioma. Br J Cancer 2004, 91:1038-1044.
31. Yamamoto M., Oshiro S., Tsugu H., Hirakawa K., Ikeda K., Soma G., et al. Treatment of recurrent malignant supratentorial astrocytomas with carboplatin and etoposide combined with recombinant mutant human tumor necrosis factor-alpha. Anticancer Res 2002, 22:2447-2453.
32. Robins H.I., Chang S.M., Prados M.D., Yung W.K., Hess K., Schiff D., et al. A phase II trial of thymidine and carboplatin for recurrent malignant glioma: a North American Brain Tumor Consortium Study. Neuro Oncol 2002, 4:109-114.
33. Vinolas N., Gil M., Verger E., Villa S., Pujol T., Ceral L., et al. Pre-irradiation semi-intensive chemotherapy with carboplatin and cyclophosphamide in malignant glioma: a phase II study. Anticancer Drugs 2002, 13:163-167.
34. Lopez-Aguilar E., Sepulveda-Vildosola A.C., Rivera-Marquez H., Cerecedo-Diaz F., Hernandez-Contreras I., Ramon-Garcia G., et al. Preirradiation ifosfamide, carboplatin, and etoposide for the treatment of anaplastic astrocytomas and glioblastoma multiforme: a phase II study. Arch Med Res 2000, 31:186-190.
35. Brandes A.A., Rigon A., Zampieri P., Ermani M., Carollo C., Altavilla G., et al. Carboplatin and teniposide concurrent with radiotherapy in patients with glioblastoma multiforme: a phase II study. Cancer 1998, 82:355-361.
36. Whittle I.R., Malcolm G., Jodrell D.I., Reid M. Platinum distribution in malignant glioma following intraoperative intravenous infusion of carboplatin. Br J Neurosurg 1999, 13:132-137.
37. Cloughesy T.F., Gobin Y.P., Black K.L., Vinuela F., Taft F., Kadkhoda B., et al. Intra-arterial carboplatin chemotherapy for brain tumors: a dose escalation study based on cerebral blood flow. J Neurooncol 1997, 35:121-131.
38. Fortin D., Desjardins A., Benko A., Niyonsega T., Boudrias M. Enhanced chemotherapy delivery by intraarterial infusion and blood-brain barrier disruption in malignant brain tumors: the Sherbrooke experience. Cancer 2005, 103:2606-2615.
39. Stewart D.J., Belanger J.M., Grahovac Z., Curuvija S., Gionet L.R., Aitken S.E., et al. Phase I study of intracarotid administration of carboplatin. Neurosurgery 1992, 30:512-516. (discussion 6-7).
40. Ginos J.Z., Cooper A.J., Dhawan V., Lai J.C., Strother S.C., Alcock N., et al. [13N]cisplatin PET to assess pharmacokinetics of intra-arterial versus intravenous chemotherapy for malignant brain tumors. J Nucl Med 1987, 28:1844-1852.
41. Degen J.W., Walbridge S., Vortmeyer A.O., Oldfield E.H., Lonser R.R. Safety and efficacy of convection-enhanced delivery of gemcitabine or carboplatin in a malignant glioma model in rats. J Neurosurg 2003, 99:893-898.
42. Strege R.J., Liu Y.J., Kiely A., Johnson R.M., Gillis E.M., Storm P., et al. Toxicity and cerebrospinal fluid levels of carboplatin chronically infused into the brainstem of a primate. J Neurooncol 2004, 67:327-334.
43. May B.J., Guarnieri M., Carson B.S., Bachani A., Jallo G.I. Long-term effects of carboplatin brainstem infusions on hearing thresholds in monkeys. Arch Otolaryngol Head Neck Surg 2004, 130:1411-1415.
44. AHFS Drug Information. Monograph - carboplatin.
45. Szentistvanyi I., Patlak C.S., Ellis R.A., Cserr H.F. Drainage of interstitial fluid from different regions of rat brain. Am J Physiol 1984, 246:F835-F844.
46. Gill S.S., Patel N.K., Hotton G.R., O'Sullivan K., McCarter R., Bunnage M., et al. Direct brain infusion of glial cell line-derived neurotrophic factor in Parkinson disease. Nat Med 2003, 9:589-595.
47. Patel N.K., Bunnage M., Plaha P., Svendsen C.N., Heywood P., Gill S.S. Intraputamenal infusion of glial cell line-derived neurotrophic factor in PD: a two-year outcome study. Ann Neurol 2005, 57:298-302.
48. Ng F., Mastoroudes H., Paul E., Davies N., Tibballs J., Hochhauser D., et al. A comparison of Hickman line- and Port-a-Cath-associated complications in patients with solid tumours undergoing chemotherapy. Clin Oncol (R Coll Radiol) 2007, 19:551-556.
49. Mardor Y., Rahav O., Zauberman Y., Lidar Z., Ocherashvilli A., Daniels D., et al. Convection-enhanced drug delivery: increased efficacy and magnetic resonance image monitoring. Cancer Res 2005, 65:6858-6863.
50. Macdonald D.R., Cascino T.L., Schold S.C., Cairncross J.G. Response criteria for phase II studies of supratentorial malignant glioma. J Clin Oncol 1990, 8:1277-1280.
51. Chen M.Y., Hoffer A., Morrison P.F., Hamilton J.F., Hughes J., Schlageter K.S., et al. Surface properties, more than size, limiting convective distribution of virus-sized particles and viruses in the central nervous system. J Neurosurg 2005, 103:311-319.
52. Weaver M., Laske D.W. Transferrin receptor ligand-targeted toxin conjugate (Tf-CRM107) for therapy of malignant gliomas. J Neurooncol 2003, 65:3-13.
53. Krauze M.T., Saito R., Noble C., Bringas J., Forsayeth J., McKnight T.R., et al. Effects of the perivascular space on convection-enhanced delivery of liposomes in primate putamen. Exp Neurol 2005, 196:104-111.
54. Love S., Plaha P., Patel N.K., Hotton G.R., Brooks D.J., Gill S.S. Glial cell line-derived neurotrophic factor induces neuronal sprouting in human brain. Nat Med 2005, 11:703-704.
55. Fiandaca M.S., Varenika V., Eberling J., McKnight T., Bringas J., Pivirotto P., et al. Real-time MR imaging of adeno-associated viral vector delivery to the primate brain. Neuroimage 2009, 47(Suppl. 2):T27-T35.
56. Su X., Kells A.P., Aguilar Salegio E.A., Richardson R.M., Hadaczek P., Beyer J., et al. Real-time MR imaging with Gadoteridol predicts distribution of transgenes after convection-enhanced delivery of AAV2 vectors. Mol Ther 2010, 18(8):1490-1495.
57. Valles F., Fiandaca M.S., Eberling J.L., Starr P.A., Larson P.S., Christine C.W., et al. Qualitative imaging of adeno-associated virus serotype 2-human aromatic L-amino acid decarboxylase gene therapy in a phase I study for the treatment of Parkinson disease. Neurosurgery 2010, 67(5):1377-1385.
58. White E., Bienemann A., Megraw L., Bunnun C., Gill S. Evaluation and optimization of the administration of a selectively replicating herpes simplex viral vector to the brain by convection-enhanced delivery. Cancer Gene Ther 2011, 18(5):358-369.
59. Richardson R.M., Gimenez F., Salegio E.A., Su X., Bringas J., Berger M.S., et al. T2 imaging in monitoring of intraparenchymal real-time convection-enhanced delivery. Neurosurgery 2011, 69:154-163. [discussion 63].
60. Sampson J.H., Raghavan R., Provenzale J.M., Croteau D., Reardon D.A., Coleman R.E., et al. Induction of hyperintense signal on T2-weighted MR images correlates with infusion distribution from intracerebral convection-enhanced delivery of a tumor-targeted cytotoxin. AJR Am J Roentgenol 2007, 188:703-709.
61. Iyer R.R., Butman J.A., Walbridge S., Gai N.D., Heiss J.D., Lonser R.R. Tracking accuracy of T2- and diffusion-weighted magnetic resonance imaging for infusate distribution by convection-enhanced delivery. J Neurosurg 2011, 115:474-480.