Depocyte in the Treatment of CNS Relapse in Patients With Lymphoblastic Leucemia or Very Aggressive Lymphoma

Summary

The first purpose is to confirm or not the efficacy of only one administration of DepoCyte®.

Timeline

Start

2006-03

Primary completion

2011-03

Completion

2011-06

Publications

• Background Mastrangelo R, Poplack D, Bleyer A, Riccardi R, Sather H, D'Angio G. Report and recommendations of the Rome workshop concerning poor-prognosis acute lymphoblastic leukemia in children: biologic bases for staging, stratification, and treatment. Med Pediatr Oncol. 1986;14(3):191-4. doi: 10.1002/mpo.2950140317. No abstract available.
• Background Gokbuget N, Hoelzer D. Meningeosis leukaemica in adult acute lymphoblastic leukaemia. J Neurooncol. 1998 Jun-Jul;38(2-3):167-80. doi: 10.1023/a:1005963732481.
• Background Neale GA, Pui CH, Mahmoud HH, Mirro J Jr, Crist WM, Rivera GK, Goorha RM. Molecular evidence for minimal residual bone marrow disease in children with 'isolated' extra-medullary relapse of T-cell acute lymphoblastic leukemia. Leukemia. 1994 May;8(5):768-75.
• Background Ribeiro RC, Rivera GK, Hudson M, Mulhern RK, Hancock ML, Kun L, Mahmoud H, Sandlund JT, Crist WM, Pui CH. An intensive re-treatment protocol for children with an isolated CNS relapse of acute lymphoblastic leukemia. J Clin Oncol. 1995 Feb;13(2):333-8. doi: 10.1200/JCO.1995.13.2.333.
• Background Larson RA, Dodge RK, Burns CP, Lee EJ, Stone RM, Schulman P, Duggan D, Davey FR, Sobol RE, Frankel SR, et al. A five-drug remission induction regimen with intensive consolidation for adults with acute lymphoblastic leukemia: cancer and leukemia group B study 8811. Blood. 1995 Apr 15;85(8):2025-37.
• Background Mandelli F, Annino L, Rotoli B. The GIMEMA ALL 0183 trial: analysis of 10-year follow-up. GIMEMA Cooperative Group, Italy. Br J Haematol. 1996 Mar;92(3):665-72. doi: 10.1046/j.1365-2141.1996.00394.x.
• Background Morra E, Lazzarino M, Brusamolino E, Pagnucco G, Castagnola C, Bernasconi P, Orlandi E, Corso A, Santagostino A, Bernasconi C. The role of systemic high-dose cytarabine in the treatment of central nervous system leukemia. Clinical results in 46 patients. Cancer. 1993 Jul 15;72(2):439-45. doi: 10.1002/1097-0142(19930715)72:23.0.co;2-4.
• Background Ellison RR, Mick R, Cuttner J, Schiffer CA, Silver RT, Henderson ES, Woliver T, Royston I, Davey FR, Glicksman AS, et al. The effects of postinduction intensification treatment with cytarabine and daunorubicin in adult acute lymphocytic leukemia: a prospective randomized clinical trial by Cancer and Leukemia Group B. J Clin Oncol. 1991 Nov;9(11):2002-15. doi: 10.1200/JCO.1991.9.11.2002.
• Background Durrant IJ, Richards SM. Results of Medical Research Council trial UKALL IX in acute lymphoblastic leukaemia in adults: report from the Medical Research Council Working Party on Adult Leukaemia. Br J Haematol. 1993 Sep;85(1):84-92. doi: 10.1111/j.1365-2141.1993.tb08649.x.
• Background Elonen E, Almqvist A, Hänninen A et al. Intensive treatment of acute lymphatic leukaemia in adults: ALL86 protocol. Haematologica. 1991;76 (Suppl 4):133
• Background Gökbuget N, Aguion-Freire E, Diedrich H et al. Characteristics and outcome of CNS relapse in patients with acute lymphoblastic leukemia (ALL) [abstract]. Blood. 1999;94:1287a.
• Background Gökbuget N, Arnold R, Eggeling B et al. Prospective evaluation of neurotoxicity of prophylactic intrathecal therapy in adult acute lymphoblastic leukemia. The Hematology Journal. 2000;1:591a.
• Background Chessells JM. Central nervous system directed therapy in acute lymphoblastic leukaemia. Baillieres Clin Haematol. 1994 Jun;7(2):349-63. doi: 10.1016/s0950-3536(05)80207-0.
• Background Gagliano RG, Costanzi JJ. Paraplegia following intrathecal methotrexate: report of a case and review of the literature. Cancer. 1976 Apr;37(4):1663-8. doi: 10.1002/1097-0142(197604)37:43.0.co;2-7.
• Background Dunton SF, Nitschke R, Spruce WE, Bodensteiner J, Krous HF. Progressive ascending paralysis following administration of intrathecal and intravenous cytosine arabinoside. A Pediatric Oncology Group study. Cancer. 1986 Mar 15;57(6):1083-8. doi: 10.1002/1097-0142(19860315)57:63.0.co;2-b.
• Background Bleyer WA, Poplack DG. Prophylaxis and treatment of leukemia in the central nervous system and other sanctuaries. Semin Oncol. 1985 Jun;12(2):131-48. No abstract available.
• Background Glass JP, Lee YY, Bruner J, Fields WS. Treatment-related leukoencephalopathy. A study of three cases and literature review. Medicine (Baltimore). 1986 May;65(3):154-62.
• Background Graham FL, Whitmore GF. The effect of-beta-D-arabinofuranosylcytosine on growth, viability, and DNA synthesis of mouse L-cells. Cancer Res. 1970 Nov;30(11):2627-35. No abstract available.
• Background Zimm S, Collins JM, Curt GA, O'Neill D, Poplack DG. Cerebrospinal fluid pharmacokinetics of intraventricular and intravenous aziridinylbenzoquinone. Cancer Res. 1984 Apr;44(4):1698-701.
• Background Murry DJ, Blaney SM. Clinical pharmacology of encapsulated sustained-release cytarabine. Ann Pharmacother. 2000 Oct;34(10):1173-8. doi: 10.1345/aph.19347.
• Background Kim S, Chatelut E, Kim JC, Howell SB, Cates C, Kormanik PA, Chamberlain MC. Extended CSF cytarabine exposure following intrathecal administration of DTC 101. J Clin Oncol. 1993 Nov;11(11):2186-93. doi: 10.1200/JCO.1993.11.11.2186.
• Background Chamberlain MC, Khatibi S, Kim JC, Howell SB, Chatelut E, Kim S. Treatment of leptomeningeal metastasis with intraventricular administration of depot cytarabine (DTC 101). A phase I study. Arch Neurol. 1993 Mar;50(3):261-4. doi: 10.1001/archneur.1993.00540030027009.
• Background Chamberlain MC, Kormanik P, Howell SB, Kim S. Pharmacokinetics of intralumbar DTC-101 for the treatment of leptomeningeal metastases. Arch Neurol. 1995 Sep;52(9):912-7. doi: 10.1001/archneur.1995.00540330094020.
• Background Glantz MJ, LaFollette S, Jaeckle KA, Shapiro W, Swinnen L, Rozental JR, Phuphanich S, Rogers LR, Gutheil JC, Batchelor T, Lyter D, Chamberlain M, Maria BL, Schiffer C, Bashir R, Thomas D, Cowens W, Howell SB. Randomized trial of a slow-release versus a standard formulation of cytarabine for the intrathecal treatment of lymphomatous meningitis. J Clin Oncol. 1999 Oct;17(10):3110-6. doi: 10.1200/JCO.1999.17.10.3110.
• Background Howell SB. Liposomal cytarabine for the treatment of lymphomatous meningitis. Biological Therapy of Lymphoma. 2003;6:10-14.
• Background Glantz MJ, Jaeckle KA, Chamberlain MC, Phuphanich S, Recht L, Swinnen LJ, Maria B, LaFollette S, Schumann GB, Cole BF, Howell SB. A randomized controlled trial comparing intrathecal sustained-release cytarabine (DepoCyt) to intrathecal methotrexate in patients with neoplastic meningitis from solid tumors. Clin Cancer Res. 1999 Nov;5(11):3394-402.
• Background Bomgaars J, Geyer J, Franklin J, et al. A phase I study of intrathecal liposomal cytarabine (DepoCyt) in pediatric patients with advanced meningeal malignancies. Proc Am Soc Clin Oncol. 2002;Abstract 433.
• Background Jaeckle KA, Phuphanich S, Bent MJ, Aiken R, Batchelor T, Campbell T, Fulton D, Gilbert M, Heros D, Rogers L, O'Day SJ, Akerley W, Allen J, Baidas S, Gertler SZ, Greenberg HS, LaFollette S, Lesser G, Mason W, Recht L, Wong E, Chamberlain MC, Cohn A, Glantz MJ, Gutheil JC, Maria B, Moots P, New P, Russell C, Shapiro W, Swinnen L, Howell SB. Intrathecal treatment of neoplastic meningitis due to breast cancer with a slow-release formulation of cytarabine. Br J Cancer. 2001 Jan;84(2):157-63. doi: 10.1054/bjoc.2000.1574.
• Background Jaeckle KA, Batchelor T, O'Day SJ, Phuphanich S, New P, Lesser G, Cohn A, Gilbert M, Aiken R, Heros D, Rogers L, Wong E, Fulton D, Gutheil JC, Baidas S, Kennedy JM, Mason W, Moots P, Russell C, Swinnen LJ, Howell SB. An open label trial of sustained-release cytarabine (DepoCyt) for the intrathecal treatment of solid tumor neoplastic meningitis. J Neurooncol. 2002 May;57(3):231-9. doi: 10.1023/a:1015752331041.
• Background Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T; CONSORT GROUP (Consolidated Standards of Reporting Trials). The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001 Apr 17;134(8):663-94. doi: 10.7326/0003-4819-134-8-200104170-00012.

Drugs

Indications