A Phase I Study of Vincristine, Irinotecan, Temozolomide and Bevacizumab (Vitb) in Pediatric Patients with Relapsed Solid Tumors

PLoS ONE

Volumn 8, Issue 7, 2013, Pages

  Venkatramani, Rajkumar ^a,b   Malogolowkin, Marcio ^c   Davidson, Tom B ^d   May, William ^a,b   Sposto, Richard ^a,b   Mascarenhas, Leo ^a,b  

^a CHILDREN S HOSPITAL LOS ANGELES   (United States)

^b UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^c MEDICAL COLLEGE OF WISCONSIN   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIHYPERTENSIVE AGENT; BEVACIZUMAB; IRINOTECAN; LOPERAMIDE; TEMOZOLOMIDE; VINCRISTINE; ANTINEOPLASTIC AGENT; CAMPTOTHECIN; DACARBAZINE; MONOCLONAL ANTIBODY;

ADOLESCENT; ADULT; ANEMIA; ANGIOSARCOMA; ANTINEOPLASTIC ACTIVITY; ARTERIAL THROMBOEMBOLISM; ARTICLE; BLEEDING DISORDER; BLOOD TOXICITY; BONE MARROW SUPPRESSION; BRAIN HEMORRHAGE; CANCER PATIENT; CARDIOTOXICITY; CHILD; CLINICAL ARTICLE; COLITIS; CONTROLLED STUDY; DIARRHEA; DRUG DOSE ESCALATION; DRUG FEVER; DRUG WITHDRAWAL; EPISTAXIS; EWING SARCOMA; FEMALE; GROWTH PLATE; HUMAN; HYPERBILIRUBINEMIA; HYPERTENSION; HYPOALBUMINEMIA; HYPOCALCEMIA; HYPOKALEMIA; HYPONATREMIA; INTESTINE PERFORATION; LEUKOENCEPHALOPATHY; LEUKOPENIA; LIPOSARCOMA; LIVER CELL CARCINOMA; MALE; MEDULLOBLASTOMA; MULTIPLE CYCLE TREATMENT; NEPHROBLASTOMA; NEUROPATHY; NEUTROPENIA; OSTEOSARCOMA; PAIN; PHASE 1 CLINICAL TRIAL; POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME; PRESCHOOL CHILD; PROSPECTIVE STUDY; PROTEINURIA; SIDE EFFECT; SOLID TUMOR; SYNOVIAL SARCOMA; THROMBOCYTOPENIA; THROMBOSIS; TREATMENT RESPONSE; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; DOSE RESPONSE; MAXIMUM TOLERATED DOSE; NEOPLASMS; RECURRENT DISEASE; YOUNG ADULT;

ADULT; AGED; ANTINEOPLASTIC AGENTS, ALKYLATING; BRACHYTHERAPY; BRAIN NEOPLASMS; CHEMORADIOTHERAPY; CHEMOTHERAPY, ADJUVANT; DACARBAZINE; DOSE FRACTIONATION; FEMALE; FOLLOW-UP STUDIES; GLIOBLASTOMA; HUMANS; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; PROGNOSIS; PROSPECTIVE STUDIES; RADIOTHERAPY PLANNING, COMPUTER-ASSISTED; RADIOTHERAPY, CONFORMAL; RADIOTHERAPY, INTENSITY-MODULATED; SURVIVAL RATE; YOUNG ADULT; ADOLESCENT; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; CAMPTOTHECIN; CHILD; CHILD, PRESCHOOL; DOSE-RESPONSE RELATIONSHIP, DRUG; MAXIMUM TOLERATED DOSE; NEOPLASMS; RECURRENCE; VINCRISTINE;

EID: 84880684324     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0068416     Document Type: Article

References (27)

1. Kushner BH, Kramer K, Modak S, Cheung N-KV, (2006) Irinotecan Plus Temozolomide for Relapsed or Refractory Neuroblastoma. J Clin Oncol 24: 5271-5276. doi:10.1200/JCO.2006.06.7272. PubMed: 17114661.
2. Wagner LM, McAllister N, Goldsby RE, Rausen AR, McNall-Knapp RY, et al. (2007) Temozolomide and intravenous irinotecan for treatment of advanced Ewing sarcoma. Pediatr Blood Cancer 48: 132-139. doi:10.1002/pbc.20697. PubMed: 16317751.
3. Houghton PJ, Stewart CF, Cheshire PJ, Richmond LB, Kirstein MN, et al. (2000) Antitumor Activity of Temozolomide Combined with Irinotecan Is Partly Independent of O6-Methylguanine-DNA Methyltransferase and Mismatch Repair Phenotypes in Xenograft Models. Clin Cancer Res 6: 4110-4118. PubMed: 11051264.
4. Wagner LM, Crews KR, Iacono LC, Houghton PJ, Fuller CE, et al. (2004) Phase I Trial of Temozolomide and Protracted Irinotecan in Pediatric Patients with Refractory Solid Tumors. Clin Cancer Res 10: 840-848. doi:10.1158/1078-0432.CCR-03-0175. PubMed: 14871959.
5. Mascarenhas L, Lyden ER, Breitfeld PP, Walterhouse DO, Donaldson SS, et al. (2010) Randomized phase II window trial of two schedules of irinotecan with vincristine in patients with first relapse or progression of rhabdomyosarcoma: a report from the Children's Oncology Group. J Clin Oncol 28: 4658-4663. doi:10.1200/JCO.2010.29.7390. PubMed: 20837952.
6. Furman WL, Stewart CF, Poquette CA, Pratt CB, Santana VM, et al. (1999) Direct translation of a protracted irinotecan schedule from a xenograft model to a phase I trial in children. J Clin Oncol 17: 1815-1824. PubMed: 10561220.
7. Wagner LM, Perentesis JP, Reid JM, Ames MM, Safgren SL, et al. (2010) Phase I trial of two schedules of vincristine, oral irinotecan, and temozolomide (VOIT) for children with relapsed or refractory solid tumors: a Children's Oncology Group phase I consortium study. Pediatr Blood Cancer 54: 538-545. PubMed: 20049936.
8. Presta LG, Chen H, O'Connor SJ, Chisholm V, Meng YG, et al. (1997) Humanization of an Anti-Vascular Endothelial Growth Factor Monoclonal Antibody for the Therapy of Solid Tumors and Other Disorders. Cancer Res 57: 4593-4599. PubMed: 9377574.
9. Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, et al. (2004) Bevacizumab plus Irinotecan, Fluorouracil, and Leucovorin for Metastatic Colorectal Cancer. N Engl J Med 350: 2335-2342. doi:10.1056/NEJMoa032691. PubMed: 15175435.
10. Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, et al. (2009) Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil. J Clin Oncol 27: 1227-1234. doi:10.1200/JCO.2007.14.5466. PubMed: 19188680.
11. Yang JC, Haworth L, Sherry RM, Hwu P, Schwartzentruber DJ, et al. (2003) A Randomized Trial of Bevacizumab, an Anti-Vascular Endothelial Growth Factor Antibody, for Metastatic Renal Cancer. N Engl J Med 349: 427-434. doi:10.1056/NEJMoa021491. PubMed: 12890841.
12. Rowe DH, Huang J, Kayton ML, Thompson R, Troxel A, et al. (2000) Anti-VEGF antibody suppresses primary tumor growth and metastasis in an experimental model of Wilms' tumor. J Pediatr Surg 35: 30-32; discussion 32-3. doi:10.1016/S0022-3468(00)80008-1. PubMed: 10646769.
13. McCrudden KW, Hopkins B, Frischer J, Novikov A, Huang J, et al. (2003) Anti-VEGF antibody in experimental hepatoblastoma: suppression of tumor growth and altered angiogenesis. J Pediatr Surg 38: 308-314; discussion 308-314. doi:10.1053/jpsu.2003.50099. PubMed: 12632340.
14. Rowe DH, Huang J, Li J, Manley C, O'Toole KM, et al. (2000) Suppression of primary tumor growth in a mouse model of human neuroblastoma. J Pediatr Surg 35: 977-981. doi:10.1053/jpsu.2000.6946. PubMed: 10873048.
15. Glade Bender JL, Adamson PC, Reid JM, Xu L, Baruchel S, et al. (2008) Phase I trial and pharmacokinetic study of bevacizumab in pediatric patients with refractory solid tumors: a Children's Oncology Group Study. J Clin Oncol 26: 399-405. doi:10.1200/JCO.2007.11.9230. PubMed: 18202416.
16. Packer RJ, Jakacki R, Horn M, Rood B, Vezina G, et al. (2009) Objective response of multiply recurrent low-grade gliomas to bevacizumab and irinotecan. Pediatr Blood Cancer 52: 791-795. doi:10.1002/pbc.21935. PubMed: 19165892.
17. Narayana A, Kunnakkat S, Chacko-Mathew J, Gardner S, Karajannis M, et al. (2010) Bevacizumab in recurrent high-grade pediatric gliomas. Neuro Oncol 12: 985-990. doi:10.1093/neuonc/noq033. PubMed: 20363768.
18. Aguilera D, Mazewski C, Fangusaro J, Macdonald TJ, McNall-Knapp RY, et al. (2013) Response to bevacizumab, irinotecan, and temozolomide in children with relapsed medulloblastoma: a multi-institutional experience. Childs: Nerv Syst.
19. Blaney S, Berg SL, Pratt C, Weitman S, Sullivan J, et al. (2001) A Phase I Study of Irinotecan in Pediatric Patients: A Pediatric Oncology Group Study. Clin Cancer Res 7: 32-37. PubMed: 11205914.
20. Vassal G, Doz F, Frappaz D, Imadalou K, Sicard E, et al. (2003) A Phase I Study of Irinotecan As a 3-Week Schedule in Children With Refractory or Recurrent Solid Tumors. J Clin Oncol 21: 3844-3852. doi:10.1200/JCO.2003.08.175. PubMed: 14551303.
21. Bomgaars LR, Bernstein M, Krailo M, Kadota R, Das S, et al. (2007) Phase II Trial of Irinotecan in Children With Refractory Solid Tumors: A Children's Oncology Group Study. J Clin Oncol 25: 4622-4627. doi:10.1200/JCO.2007.11.6103. PubMed: 17925558.
22. Vredenburgh JJ, Desjardins A, Herndon JE, Marcello J, Reardon DA, et al. (2007) Bevacizumab Plus Irinotecan in Recurrent Glioblastoma Multiforme. J Clin Oncol 25: 4722-4729. doi:10.1200/JCO.2007.12.2440. PubMed: 17947719.
23. Houghton PJ, Cheshire PJ, Hallman JD 2nd, Lutz L, Friedman HS, et al. (1995) Efficacy of topoisomerase I inhibitors, topotecan and irinotecan, administered at low dose levels in protracted schedules to mice bearing xenografts of human tumors. Cancer Chemother Pharmacol 36: 393-403. doi:10.1007/BF00686188. PubMed: 7634381.
24. Gururangan S, Chi SN, Young Poussaint T, Onar-Thomas A, Gilbertson RJ, et al. (2010) Lack of Efficacy of Bevacizumab Plus Irinotecan in Children With Recurrent Malignant Glioma and Diffuse Brainstem Glioma: A Pediatric Brain Tumor Consortium Study. J Clin Oncol 28: 3069-3075. doi:10.1200/JCO.2009.26.8789. PubMed: 20479404.
25. Ryan AM, Eppler DB, Hagler KE, Bruner RH, Thomford PJ, et al. (1999) Preclinical safety evaluation of rhuMAbVEGF, an antiangiogenic humanized monoclonal antibody. Toxicol Pathol 27: 78-86. doi:10.1177/019262339902700115. PubMed: 10367678.
26. Rowe DH, Huang J, Kayton ML, Thompson R, Troxel A, et al. (2000) Anti-VEGF antibody suppresses primary tumor growth and metastasis in an experimental model of Wilms' tumor. J Pediatr Surg 35: 30-32; discussion 32-33. doi:10.1016/S0022-3468(00)80008-1. PubMed: 10646769.
27. Frischer JS, Huang J, Serur A, Kadenhe-Chiweshe A, McCrudden KW, et al. (2004) Effects of potent VEGF blockade on experimental Wilms tumor and its persisting vasculature. Int J Oncol 25: 549-553. PubMed: 15289855.