Phase I/II study of 131 I-MIBG with vincristine and 5 days of irinotecan for advanced neuroblastoma

British Journal of Cancer

Volumn 112, Issue 4, 2015, Pages 644-649

  Dubois, S G ^a   Allen, S ^a   Bent, M ^a   Hilton, J F ^b   Hollinger, F ^a   Hawkins, R ^b   Courtier, J ^b   Mosse, Y P ^c   Matthay, K K ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

131I MIBG; irinotecan; neuroblastoma; UGT1A1; vincristine

Indexed keywords

(3 IODOBENZYL)GUANIDINE I 131; ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; AMYLASE; ASPARTATE AMINOTRANSFERASE; CEFIXIME; CEFPODOXIME; FILGRASTIM; IRINOTECAN; PEGFILGRASTIM; VINCRISTINE; (3 IODOBENZYL)GUANIDINE; ANTINEOPLASTIC AGENT; CAMPTOTHECIN; RADIOACTIVE IODINE;

ABDOMINAL PAIN; ACUTE GRANULOCYTIC LEUKEMIA; ADOLESCENT; ADULT; ADVANCED CANCER; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ALOPECIA; AMYLASE BLOOD LEVEL; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BONE MARROW SUPPRESSION; BONE PAIN; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER RADIOTHERAPY; CHEMOTHERAPY INDUCED EMESIS; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; CHILD; CONSTIPATION; COUGHING; DEHYDRATION; DIARRHEA; DOSIMETRY; DRUG DOSE ESCALATION; DRUG ERUPTION; FATIGUE; FEMALE; GENOTYPE; HUMAN; HYPOALBUMINEMIA; HYPOKALEMIA; HYPOMAGNESEMIA; HYPONATREMIA; HYPOTHYROIDISM; KARNOFSKY PERFORMANCE STATUS; LIFE EXPECTANCY; MALE; MAXIMUM PERMISSIBLE DOSE; MOUTH PAIN; MULTIMODALITY CANCER THERAPY; MYELODYSPLASTIC SYNDROME; NEUROBLASTOMA; NEUTROPENIA; PERIPHERAL BLOOD STEM CELL TRANSPLANTATION; PHARMACOGENOMICS; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; SKIN DISEASE; SORE THROAT; SYSTEMIC THERAPY; THROMBOCYTOPENIA; TREATMENT RESPONSE; URINARY TRACT PAIN; WEIGHT REDUCTION; WHOLE BODY RADIATION; XEROSTOMIA; ANALOGS AND DERIVATIVES; CHEMORADIOTHERAPY; CLINICAL TRIAL; DOSE RESPONSE; DRUG ADMINISTRATION; GENETICS; MAXIMUM TOLERATED DOSE; PRESCHOOL CHILD; RADIATION DOSE; YOUNG ADULT;

3-IODOBENZYLGUANIDINE; ADOLESCENT; ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; CHEMORADIOTHERAPY; CHILD; CHILD, PRESCHOOL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; IODINE RADIOISOTOPES; MALE; MAXIMUM TOLERATED DOSE; NEUROBLASTOMA; RADIOTHERAPY DOSAGE; VINCRISTINE; YOUNG ADULT;

EID: 84923562128     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/bjc.2015.12     Document Type: Article

References (26)

1. Ady N, Zucker JM, Asselain B, Edeline V, Bonnin F, Michon J, Gongora R, Manil L. (1995). 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 31A: 256-261
2. Bagatell R, London WB, Wagner LM, Voss SD, Stewart CF, Maris JM, Kretschmar C, Cohn SL. (2011). Phase II study of irinotecan and temozolomide in children with relapsed or refractory neuroblastoma: a Children's Oncology Group Study. J Clin Oncol 29: 208-213
3. Clopper CJ, Pearson ES. (1934). The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 26: 404-413
4. Deeken JF, Slack R, Marshall JL. (2008). Irinotecan and uridine diphosphate glucuronosyltransferase 1A1 pharmacogenetics: to test or not to test, that is the question. Cancer 113: 1502-1510
5. DuBois SG, Chesler L, Groshen S, Hawkins R, Goodarzian F, Shimada H, Yanik G, Tagen M, Stewart C, Mosse YP, Maris JM, Tsao-Wei D, Marachelian A, Villablanca JG, Matthay KK. (2012). Phase I study of vincristine, irinotecan, and (1)(3)(1)I-metaiodobenzylguanidine for patients with relapsed or refractory neuroblastoma: a new approaches to neuroblastoma therapy trial. Clin Cancer Res 18: 2679-2686
6. DuBois SG, Matthay KK. (2008). Radiolabeled metaiodobenzylguanidine for the treatment of neuroblastoma. Nucl Med Biol 35(Suppl 1): S35-S48
7. Du Bois SG, Messina J, Maris JM, Huberty J, Glidden DV, Veatch J, Charron M, Hawkins R, Matthay KK. (2004). Hematologic toxicity of high-dose iodine-131-metaiodobenzylguanidine therapy for advanced neuroblastoma. J Clin Oncol 22: 2452-2460
8. Gains JE, Walker C, Sullivan TM, Waddington WA, Fersht NL, Sullivan KP, Armstrong E, D'souza DP, Aldridge MD, Bomanji JB, Gaze MN. (2014). Radiation exposure to comforters and carers during paediatric molecular radiotherapy. Pediatr Blood Cancer
9. Gaze MN, Chang YC, Flux GD, Mairs RJ, Saran FH, Meller ST. (2005). Feasibility of dosimetry-based high-dose 131I-meta-iodobenzylguanidine with topotecan as a radiosensitizer in children with metastatic neuroblastoma. Cancer Biother Radiopharm 20: 195-199
10. Hoskins JM, Goldberg RM, Qu P, Ibrahim JG, Mcleod HL. (2007). UGT1A1∗28 genotype and irinotecan-induced neutropenia: dose matters. J Natl Cancer Inst 99: 1290-1295
11. Hu ZY, Yu Q, Zhao YS. (2010). Dose-dependent association between UGT1A1∗28 polymorphism and irinotecan-induced diarrhoea: a meta-analysis. Eur J Cancer 46: 1856-1865
12. Mascarenhas L, Lyden ER, Breitfeld PP, Walterhouse DO, Donaldson SS, Paidas CN, Parham DM, Anderson JR, Meyer WH, Hawkins DS. (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
13. Matthay KK, Panina C, Huberty J, Price D, Glidden DV, Tang HR, Hawkins RA, Veatch J, Hasegawa B. (2001). Correlation of tumor and whole-body dosimetry with tumor response and toxicity in refractory neuroblastoma treated with (131)I-MIBG. J Nucl Med 42: 1713-1721
14. Matthay KK, Quach A, Huberty J, Franc B, Hawkins R, Jackson H, Groshen S, Shusterman S, Yanik G, Veatch J, Brophy P, Villablanca JG, Maris JM. (2009). 131I-Metaiodobenzylguanidine (131I-MIBG) double infusion with autologous stem cell rescue for neuroblastoma: a new approaches to neuroblastoma therapy (NANT) phase I study. J Clin Oncol 27: 1020-1025
15. Matthay KK, Yanik G, Messina J, Quach A, Huberty J, Cheng SC, Veatch J, Goldsby R, Brophy P, Kersun LS, Hawkins RA, Maris JM. (2007). Phase II study on the effect of disease sites, age, and prior therapy on response to iodine-131-metaiodobenzylguanidine therapy in refractory neuroblastoma. J Clin Oncol 25: 1054-1060
16. McCluskey AG, Boyd M, Ross SC, Cosimo E, Clark AM, Angerson WJ, Gaze MN, Mairs RJ. (2005). [131I]meta-iodobenzylguanidine and topotecan combination treatment of tumors expressing the noradrenaline transporter. Clin Cancer Res 11: 7929-7937
17. O'Leary J, Muggia FM. (1998). Camptothecins: a review of their development and schedules of administration. Eur J Cancer 34: 1500-1508
18. Pappo AS, Lyden E, Breitfeld P, Donaldson SS, Wiener E, Parham D, Crews KR, Houghton P, Meyer WH. (2007). Two consecutive phase II window trials of irinotecan alone or in combination with vincristine for the treatment of metastatic rhabdomyosarcoma: the Children's Oncology Group. J Clin Oncol 25: 362-369
19. Park JR, Scott JR, Stewart CF, London WB, Naranjo A, Santana VM, Shaw PJ, Cohn SL, Matthay KK. (2011). Pilot induction regimen incorporating pharmacokinetically guided topotecan for treatment of newly diagnosed high-risk neuroblastoma: a Children's Oncology Group study. J Clin Oncol 29: 4351-4357
20. Skolnik JM, Barrett JS, Jayaraman B, Patel D, Adamson PC. (2008). Shortening the timeline of pediatric phase I trials: the rolling six design. J Clin Oncol 26: 190-195
21. Stewart CF, Panetta JC, O'shaughnessy MA, Throm SL, Fraga CH, Owens T, Liu T, Billups C, Rodriguez-Galindo C, Gajjar A, FurmanWL, Mcgregor LM. (2007). UGT1A1 promoter genotype correlates with SN-38 pharmacokinetics, but not severe toxicity in patients receiving low-dose irinotecan. J Clin Oncol 25: 2594-2600
22. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, Van Oosterom AT, Christian MC, Gwyther SG. (2000). 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 92: 205-216
23. Treuner J, Feine U, Niethammer D, Muller-SchaumburgW,Meinke J, Eibach E, Dopfer R, Klingebiel T, Grumbach S. (1984). Scintigraphic imaging of neuroblastoma with [131-I]iodobenzylguanidine. Lancet 1: 333-334
24. Wagner LM, Crews KR, Iacono LC, Houghton PJ, Fuller CE, Mccarville MB, Goldsby RE, Albritton K, Stewart CF, Santana VM. (2004). Phase I trial of temozolomide and protracted irinotecan in pediatric patients with refractory solid tumors. Clin Cancer Res 10: 840-848
25. Wagner LM, Crews KR, Stewart CF, Rodriguez-Galindo C, Mcnall-Knapp RY, Albritton K, Pappo AS, Furman WL. (2008). Reducing irinotecanassociated diarrhea in children. Pediatr Blood Cancer 50: 201-207
26. Wilson JS, Gains JE, Moroz V, Wheatley K, Gaze MN. (2014). A systematic review of 131I-meta iodobenzylguanidine molecular radiotherapy for neuroblastoma. Eur J Cancer 50: 801-815