Phase i trial of capecitabine rapidly disintegrating tablets and concomitant radiation therapy in children with newly diagnosed brainstem gliomas and high-grade gliomas

Neuro-Oncology

Volumn 15, Issue 6, 2013, Pages 759-766

  Kilburn, Lindsay B ^a,g   Kocak, Mehmet ^b,h   Schaedeli Stark, Franziska ^c   Meneses Lorente, Georgina ^c   Brownstein, Carrie ^d   Hussain, Sazzad ^d   Chintagumpala, Murali ^a   Thompson, Patrick A ^a   Gururangan, Sri ^e   Banerjee, Anuradha ^f   Paulino, Arnold C ^a   Kun, Larry ^b   Boyett, James M ^b   Blaney, Susan M ^a  

^a BAYLOR COLLEGE OF MEDICINE   (United States)

^b ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^c F HOFFMANN LA ROCHE LTD   (Switzerland)

^d HOFFMANN LA ROCHE INC   (United States)

^e DUKE CANCER INSTITUTE   (United States)

^f UNIVERSITY OF CALIFORNIA   (United States)

^g CHILDREN'S NATIONAL MEDICAL CENTER   (United States)

^h UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

Author keywords

brainstem glioma; capecitabine; pediatric; pharmacokinetic; phase I

Indexed keywords

CAPECITABINE;

ADOLESCENT; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BRAIN STEM TUMOR; CHEMORADIOTHERAPY; CHILD; CLINICAL ARTICLE; CONSTIPATION; DESQUAMATION; DIARRHEA; DISTRIBUTION VOLUME; DOSE CALCULATION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; GLIOBLASTOMA; GLIOMA; HAND FOOT SYNDROME; HUMAN; HYPERGLYCEMIA; INFECTION; LEUKOPENIA; LYMPHOCYTOPENIA; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; NAUSEA; NEUTROPENIA; PAIN; PERIPHERAL EDEMA; PHASE 1 CLINICAL TRIAL; PRESCHOOL CHILD; RADIATION DOSE; RASH; SCHOOL CHILD; SIDE EFFECT; SWEATING; TABLET DISINTEGRATION; TREATMENT RESPONSE; VOMITING;

BRAINSTEM GLIOMA; CAPECITABINE; PEDIATRIC; PHARMACOKINETIC; PHASE I;

ADOLESCENT; ADULT; ANTIMETABOLITES, ANTINEOPLASTIC; BRAIN STEM NEOPLASMS; CHEMORADIOTHERAPY; CHILD; CHILD, PRESCHOOL; DEOXYCYTIDINE; FEMALE; FLUOROURACIL; GLIOMA; HUMANS; MALE; MAXIMUM TOLERATED DOSE; NEOPLASM GRADING; PROGNOSIS; RADIOTHERAPY DOSAGE; SURVIVAL RATE; TABLETS; TISSUE DISTRIBUTION; YOUNG ADULT;

EID: 84878319132     PISSN: 15228517     EISSN: 15235866     Source Type: Journal    
DOI: 10.1093/neuonc/nos315     Document Type: Article

References (27)

1. Pollack IF. Brain tumors in children. N Engl J Med. 1994; 331(22): 1500-1507.
2. Broniscer A, Gajjar A. Supratentorial high-grade astrocytoma and diffuse brainstem glioma: two challenges for the pediatric oncologist. Oncologist. 2004; 9(2): 197-206.
3. Wisoff JH, Boyett JM, Berger MS, et al. Current neurosurgical management and the impact of the extent of resection in the treatment of malignant gliomas of childhood: a report of the Children's Cancer Group trial no. CCG-945. J Neurosurg. 1998; 89(1): 52-59.
4. Finlay JL, Zacharoulis S. The treatment of high grade gliomas and diffuse intrinsic pontine tumors of childhood and adolescence: a historical - and futuristic - perspective. J Neurooncol. 2005; 75(3): 253-266.
5. Albright AL, Packer RJ, Zimmerman R, et al. Magnetic resonance scans should replace biopsies for the diagnosis of diffuse brain stem gliomas: a report from the Children's Cancer Group. Neurosurgery. 1993; 33(6): 1026-1029. discussion 1029-1030.
6. Packer RJ, Boyett JM, Zimmerman RA, et al. Hyperfractionated radiation therapy (72 Gy) for children with brain stem gliomas. A Childrens Cancer Group phase I/II trial. Cancer. 1993; 72(4): 1414-1421.
7. Bradley KA, Pollack IF, Reid JM, et al. Motexafin gadolinium and involved field radiationtherapy for intrinsic pontine gliomaof childhood: a Children's Oncology Group phase I study. Neuro Oncol. 2008; 10(5): 752-758.
8. Turner CD, Chi S, Marcus KJ, et al. Phase II study of thalidomide and radiation in children with newly diagnosed brain stem gliomas and glioblastoma multiforme. J Neurooncol. 2007; 82(1): 95-101.
9. Fouladi M, Nicholson HS, Zhou T, et al. A phase II study of the farnesyl transferase inhibitor, tipifarnib, in children with recurrent or progressive high-grade glioma, medulloblastoma/primitive neuroectodermal tumor, or brainstem glioma: a Children's Oncology Group study. Cancer. 2007; 110(11): 2535-2541.
10. Broniscer A, Iacono L, Chintagumpala M, et al. Role of temozolomide after radiotherapy for newly diagnosed diffuse brainstem glioma in children: results of a multiinstitutional study (SJHG-98). Cancer. 2005; 103(1): 133-139.
11. Sanghavi SN, Needle MN, Krailo MD, et al. A phase I study of topotecan as a radiosensitizer for brainstem glioma of childhood: first report of the Children's Cancer Group-0952. Neuro Oncol. 2003; 5(1): 8-13.
12. Stupp R, Hegi ME, Mason WP, et al. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009; 10(5): 459-466.
13. Cohen KJ, Heideman RL, Zhou T, et al. Temozolomide in the treatment of children with newly diagnosed diffuse intrinsic pontine gliomas: a report from the Children's Oncology Group. Neuro Oncol. 2011; 13(4): 410-416.
14. Reigner B, Blesch K, Weidekamm E. Clinical pharmacokinetics of capecitabine. Clin Pharmacokinet. 2001; 40(2): 85-104.
15. Andreetta C, Puppin C, Minisini A, et al. Thymidine phosphorylase expression and benefit from capecitabine in patients with advanced breast cancer. Ann Oncol. 2009; 20(2): 265-271.
16. Blanquicett C, Gillespie GY, Nabors LB, et al. Induction of thymidine phosphorylase in both irradiated and shielded, contralateral human U87MG glioma xenografts: implications for a dual modality treatment using capecitabine and irradiation. Mol Cancer Ther. 2002; 1(12): 1139-1145.
17. Kim TD, Li G, Song KS, et al. Radiation-induced thymidine phosphorylase upregulation in rectal cancer is mediated by tumor-associated macrophages by monocyte chemoattractant protein-1 from cancer cells. Int J Radiat Oncol Biol Phys. 2009; 73(3): 853-860.
18. Vermund H, Gollin FF. Mechanisms of action of radiotherapy and chemotherapeutic adjuvants. A review. Cancer. 1968; 21(1): 58-76.
19. Zhu AX, Willett CG. Chemotherapeutic and biologic agents as radiosensitizers in rectal cancer. Semin Radiat Oncol. 2003; 13(4): 454-468.
20. Grunda JM, Fiveash J, Palmer CA, et al. Rationally designed pharmacogenomic treatment using concurrent capecitabine and radiotherapy for glioblastoma: gene expression profiles associated with outcome. Clin Cancer Res. 16(10): 2890-2898.
21. Institute. Common Terminology for Adverse Events (CTCAE). Version 3.0. Vol NIH Pub. No 03-5410. Bethesda, MD: US Deparment of Health and Human Services, National Institutes of Health; 2006.
22. Gieschke R, Burger HU, Reigner B, et al. Population pharmacokinetics and concentration-effect relationships of capecitabine metabolites in colorectal cancer patients. Br J Clin Pharmacol. 2003; 55(3): 252-263.
23. Beal, SL, Sheiner, LB, Boeckmann, AJ (eds). NONMEM User's Guides (1989-2006). Ellicott City, MD: Icon Development Solutions; 2006.
24. Endo M, Shinbori N, Fukase Y, et al. Induction of thymidine phosphorylase expression and enhancement of efficacy of capecitabine or 5′-deoxy-5- fluorouridine by cyclophosphamide in mammary tumor models. Int J Cancer. 1999; 83(1): 127-134.
25. Meropol NJ, Gold PJ, Diasio RB, et al. Thymidine phosphorylase expression is associated with response to capecitabine plus irinotecan in patients with metastatic colorectal cancer. J Clin Oncol. 2006; 24(25): 4069-4077.
26. Fabi A, Vidiri A, Ferretti G, et al. Dramatic regression of multiple brain metastases from breast cancer with capecitabine: another arrow at the bow? Cancer Invest. 2006; 24(4): 466-468.
27. Barrett-Lee P, Bidard FC, Pierga JY. Contemporary issues and the potential uses of capecitabine in metastatic breast cancer. Cancer Treat Rev. 2009; 35(7): 582-589.