Phase 2 trial of pemetrexed in children and adolescents with refractory solid tumors: A Children's Oncology Group study

Pediatric Blood and Cancer

Volumn 60, Issue 2, 2013, Pages 237-241

  Warwick, Anne B ^a   Malempati, Suman ^b   Krailo, Mark ^c   Melemed, Allen ^d   Gorlick, Richard ^e   Ames, Matthew M ^f   Safgren, Stephanie L ^f   Adamson, Peter C ^g   Blaney, Susan M ^h  

^a UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES   (United States)

^b OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^c UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^d ELI LILLY AND COMPANY   (United States)

^e MONTEFIORE MEDICAL CENTER   (United States)

^f MAYO GRADUATE SCHOOL   (United States)

^g CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

^h BAYLOR COLLEGE OF MEDICINE   (United States)

Author keywords

Antifolate; Pemetrexed; Phase 2

Indexed keywords

CYANOCOBALAMIN; DEXAMETHASONE; FOLINIC ACID; MULTIVITAMIN; PEMETREXED; SEROTONIN 3 ANTAGONIST;

ADOLESCENT; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; BONE MARROW SUPPRESSION; BRAIN TUMOR; CHILD; DRUG DOSE REDUCTION; EPENDYMOMA; EWING SARCOMA; FATIGUE; FEMALE; FEVER; GLIOMA; HUMAN; HYPERGLYCEMIA; HYPOPHOSPHATEMIA; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MEDULLOBLASTOMA; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROBLASTOMA; NEUROECTODERM TUMOR; NEUTROPENIA; NON BRAINSTEM HIGH GRADE GLIOMA; OSTEOSARCOMA; PHASE 2 CLINICAL TRIAL; PRESCHOOL CHILD; PRIORITY JOURNAL; RASH; RHABDOMYOSARCOMA; SCHOOL CHILD; SIDE EFFECT; SOLID TUMOR; THROMBOCYTOPENIA; TREATMENT RESPONSE; TUMOR RECURRENCE; VITAMIN SUPPLEMENTATION; VOMITING;

ADOLESCENT; ANTIMETABOLITES, ANTINEOPLASTIC; CHILD; CHILD, PRESCHOOL; FEMALE; GLUTAMATES; GUANINE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; NEOPLASMS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84871104475     PISSN: 15455009     EISSN: 15455017     Source Type: Journal    
DOI: 10.1002/pbc.24244     Document Type: Article

References (30)

1. Jones RJ, Twelves CJ. Pemetrexed: A multitargeted antifolate (ALIMTA, LY-231514). Expert Rev Anticancer Ther 2002;2:13-22.
2. Paz-Ares L, Bezares S, Tabernero JM, et al. Review of a promising new agent-Pemetrexed disodium. Cancer 2003;97:2056-2063.
3. Hazarika M, White RM, Johnson JR, et al. FDA drug approval summaries: Pemetrexed (Alimta). Oncologist 2004;9:482-488.
4. Shih C, Chen VJ, Gossett LS, et al. Ly231514, a pyrrolo[2, 3-d]pyrimidine-based antifolate that inhibits multiple folate-requiring enzymes. Cancer Res 1997;57:1116-1123.
5. Mendelsohn LG, Shih C, Chen VJ, et al. Enzyme inhibition, polyglutamation, and the effect of LY 231514 (MTA) on purine biosynthesis. Semin Oncol 1999;26:42-47.
6. Schultz RM, Patel VF, Worzalla JF, et al. Role of thymidylate synthase in the antitumor activity of the multitargeted antifolate, LY231514. Anticancer Res 1999;19:437-443.
7. Shih C, Habeck LL, Mendelsohn LG, et al. Multiple folate enzyme inhibition: Mechanism of a novel pyrrolopyrimidine-based antifolate LY231514 (MTA). Adv Enzyme Regul 1998;38:135-152.
8. Hum MC, Kamen BA. Folate, antifolates, and folate analogs in pediatric oncology. Invest New Drugs 1996;14:101-111.
9. Ahmad K. Folic acid in food prevents neuroblastoma. Lancet Oncol 2003;4:649.
10. Field MS, Anguera MC, Page R, et al. 5, 10-Methenyltetrahydrofolate synthetase activity is increased in tumors and modifies the efficacy of antipurine LY309887. Arch Biochem Biophys 2009;481:145-150.
11. Field MS, Szebenyi DM, Stover PJ. Regulation of de novo purine biosynthesis by methenyltetrahydrofolate synthetase in neuroblastoma. J Biol Chem 2006;281:4215-4221.
12. French AE, Grant R, Weitzman S, et al. Folic acid food fortification is associated with a decline in neuroblastoma. Clin Pharmacol Ther 2003;74:288-294.
13. Malempati S, Nicholson HS, Reid JM, et al. Phase I trial and pharmacokinetic study of pemetrexed in children with refractory solid tumors: The Children's Oncology Group. J Clin Oncol 2007;25:1505-1511.
14. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European organization for research and treatment of cancer, national cancer institute of the united states, national cancer institute of canada. J Natl Cancer Inst 2000. 92:205-216.
15. CTEP. Common terminology criteria for adverse events. Version 3.0, 2006.
16. Ady N, Zucker JM, Asselain B, et al. A new 123I-MIBG whole body scan scoring method-Application to the prediction of the response of metastases to induction chemotherapy in stage IV neuroblastoma. Eur J Cancer 1995;31A:256-261.
17. Database of Single Nucleotide Polymorphisms (dbSNP). Bethesda (MD): National center for biotechnology information, national library of medicine. dbSNP accession:{rs1801133, rs1801131, rs34743033, rs34489327}. Available from URL: http://www.ncbi.nlm.nih.gov/snp/. Last accessed November 23, 2011.
18. Ulrich CM, Curtin K, Potter JD, et al. Polymorphisms in the reduced folate carrier, thymidylate synthase, or methionine synthase and risk of colon cancer. Cancer Epidemiol Biomarkers Prev 2005;14:2509-2516.
19. Kawakami K, Omura K, Kanehira E, et al. Polymorphic tandem repeats in the thymidylate synthase gene is associated with its protein expression in human gastrointestinal cancers. Anticancer Res 1999;19:3249-3252.
20. Pharmacogenomics Knowledge Base (PharmGKB). Variant at chr18:647646. Available from URL: http://www.pharmgkb.org/views/reports/loadVariantReport.action?varRptId=127844061&tabType=17-tabview=tab2. Last accessed November 1, 2011.
21. PharmGKB. Variant rs1801133 at chr1:11778965 in clcn6/mthfr. Available from URL: http://www.pharmgkb.org/search/search.action?exactMatch=true&query=Variant+rs1801133+at+chr1%3A11778965+in+CLCN6%2FMTHFR&autoFlag=false. Last accessed November 1, 2011.
22. 5, 10-Methylenetetrahydrofolate Reductase; MTHFR, at Online Mendelian Inheritance in Man. Available from URL: http://omim.org/entry/607093#607093_AllelicVariant0004. Last accessed November 23, 2011.
23. Fossella FV, Gatzemeier U. Phase i trials of pemetrexed. Semin Oncol 2002;29:8-16.
24. Rinaldi DA, Kuhn JG, Burris HA, et al. A phase i evaluation of multitargeted antifolate (MTA, LY231514), administered every 21 days, utilizing the modified continual reassessment method for dose escalation. Cancer Chemother Pharmacol 1999;44:372-380.
25. Adjei AA. Pemetrexed (Alimta), a novel multitargeted antineoplastic agent. Clin Cancer Res 2004;10:4276s-4280s.
26. 12 as front-line therapy in malignant pleural mesothelioma. J Clin Oncol 2003;21:1556-1561.
27. 12 in japanese patients with solid tumours. Br J Cancer 2006;95:677-682.
28. Zhao R, Babani S, Gao F, et al. The mechanism of transport of the multitargeted antifolate (MTA) and its cross-resistance pattern in cells with markedly impaired transport of methotrexate. Clin Cancer Res 2000;6:3687-3695.
29. Schultz RM, Chen VJ, Bewley JR, et al. Biological activity of the multitargeted antifolate, MTA (LY231514), in human cell lines with different resistance mechanisms to antifolate drugs. Semin Oncol 1999;26:68-73.
30. Hanna N, Shepherd FA, Fossella FV, et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 2004;22:1589-1597.