Phase I trial of irinotecan plus temozolomide in adults with recurrent malignant glioma

Cancer

Volumn 104, Issue 7, 2005, Pages 1478-1486

  Reardon, David A ^a   Quinn, Jennifer A ^a   Rich, Jeremy N ^a   Desjardins, Annick ^a   Vredenburgh, James ^a   Gururangan, Sridharan ^a   Sathornsumetee, Sith ^a   Badruddoja, Michael ^a   McLendon, Roger ^a   Provenzale, James ^a   Herndon II, James E ^a   Dowell, Jeannette M ^a   Burkart, Jill L ^b   Hewton, Herbert B ^b   Friedman, Allan H ^a   Friedman, Henry S ^a  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b THE OHIO STATE UNIVERSITY WEXNER MEDICAL CENTER   (United States)

Author keywords

DNA methylators; Malignant glioma; Phase I study; Topoisomerase 1 inhibitors

Indexed keywords

ATROPINE; DEXAMETHASONE; DNA TOPOISOMERASE INHIBITOR; HEMOPOIETIC GROWTH FACTOR; IRINOTECAN; LOPERAMIDE; ONDANSETRON; TEMOZOLOMIDE;

ADULT; AGED; ARTICLE; BLOOD TOXICITY; CANCER GROWTH; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DRUG EFFICACY; FEMALE; GASTROINTESTINAL SYMPTOM; GLIOBLASTOMA; HUMAN; INFECTION; LIVER DISEASE; MAJOR CLINICAL STUDY; MALE; MAXIMUM TOLERATED DOSE; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; THROMBOSIS;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BRAIN NEOPLASMS; CAMPTOTHECIN; DACARBAZINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; GLIOMA; HUMANS; MAGNETIC RESONANCE IMAGING; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; PROGNOSIS; SALVAGE THERAPY; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 25144467368     PISSN: 0008543X     EISSN: None     Source Type: Journal    
DOI: 10.1002/cncr.21316     Document Type: Article

References (25)

1. Stupp R, Mason WP, Van Den Bent MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;352:987-996.
2. 6-alkylguanine-DNA alkyltransferase analysis and response to Temodal in newly diagnosed malignant glioma. J Clin Oncol. 1998;16:3851-3857.
3. Hegi ME, Diserens AC, Gorlia T, et al. MGMT gene silencing and benefit from temozolomide in glioblastoma. N Engl J Med. 2005;352:987-1003.
4. Friedman HS, Petros WP, Friedman AH, et al. Irinotecan therapy in adults with recurrent or progressive malignant glioma. J Clin Oncol. 1999;17:1516-1525.
5. Reardon DA, Quinn JA, Vredenburgh J, et al. Phase II trial of irinotecan plus celecoxib in adults with recurrent malignant glioma. Cancer. 2005;103:329-338.
6. Batchelor TT, Gilbert MR, Supko JG, et al. Phase 2 study of weekly irinotecan in adults with recurrent malignant glioma: final report of NABTT 97-11. Neurooncology. 2004;6:21-27.
7. Cloughesy TF, Filka E, Kuhn J, et al. Two studies evaluating irinotecan treatment for recurrent malignant glioma using an every-3-week regimen. Cancer. 2003;97:2381-2386.
8. Gilbert MR, Supko JG, Batchelor T, et al. Phase I clinical and pharmacokinetic study of irinotecan in adults with recurrent malignant glioma. Clin Cancer Res. 2003;9:2940-2949.
9. Prados MD, Yung WK, Jaeckle KA, et al. Phase 1 trial of irinotecan (CPT-11) in patients with recurrent malignant glioma: a North American Brain Tumor Consortium study. Neurooncology. 2004;6:44-54.
10. Raymond E, Fabbro M, Boige V, et al. Multicentre phase II study and pharmacokinetic analysis of irinotecan in chemotherapy-naive patients with glioblastoma. Ann Oncol. 2003;14:603-614.
11. 6-methylguanine-DNA methyltransferase and mismatch repair phenotypes in xenograft models. Clin Cancer Res. 2000;6:4110-4118.
12. Patel VJ, Elion GB, Houghton PJ, et al. Schedule-dependent activity of temozolomide plus CPT-11 against a human central nervous system tumor-derived xenograft. Clin Cancer Res. 2000;6:4154-4157.
13. 6-methylguanine. Cancer Research. 2001;61:53-58.
14. Kaplan E, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457-481.
15. Brookmeyer R, Crowley J. A confidence interval for the median survival time. Biometrics. 1982;38:29-41.
16. Reardon DA, Quinn JA, Rich JN, et al. Phase 2 trial of BCNU plus irinotecan in adults with malignant glioma. Neurooncology. 2004;6:134-144.
17. Yung WK, Albright RE, Olson J, et al. A phase II study of temozolomide vs. procarbazine in patients with glioblastoma multiforme at first relapse. Br J Cancer. 2000;83:588-593.
18. Yung WK, Prados MD, Yaya-Tur R, et al. Multicenter phase II trial of temozolomide in patients with anaplastic astrocytoma or anaplastic oligoastrocytoma at first relapse. Temodal Brain Tumor Group. J Clin Oncol 1999;17:2762-2771.
19. Turner CD, Gururangan S, Eastwood J, et al. Phase II study of irinotecan (CPT-11) in children with high-risk malignant brain tumors: the Duke experience. Neurooncology. 2002;4:102-108.
20. 6-benzylguanine-mediated enhancement of chemotherapy. Mol Cancer Ther. 2002;1:943-948.
21. Quinn JA, Reardon DA, Friedman AH, et al. Phase 1 trial of irinotecan plus BCNU in patients with progressive or recurrent malignant glioma. Neurooncology. 2004;6:145-153.
22. Fuchs CS, Moore MR, Harker G, et al. Phase III comparison of two irinotecan dosing regimens in second-line therapy of metastatic colorectal cancer. J Clin Oncol. 2003;21:807-814.
23. Ferez EA, Hillman DW, Mailliard JA, et al. Randomized phase II study of two irinotecan schedules for patients with metastatic breast cancer refractory to an anthracycline, a taxane, or both. J Clin Oncol. 2004;22:2849-2855.
24. Jones SF, Gian VG, Greco FA, et al. Phase I trial of irinotecan and temozolomide in patients with solid tumors. Oncology (Hunting). 2003;17:41-45.
25. Gruber ML, Buster WP. Temozolomide in combination with irinotecan for treatment of recurrent malignant glioma. Am J Clin Oncol. 2004;27:33-38