Phase II trial of irinotecan and thalidomide in adults with recurrent glioblastoma multiforme

Neuro-Oncology

Volumn 10, Issue 2, 2008, Pages 216-222

  Puduvalli, Vinay K ^a,b   Giglio, Pierre ^a   Groves, Morris D ^a   Hess, Kenneth R ^a   Gilbert, Mark R ^a   Mahankali, Srikanth ^b   Jackson, Edward F ^b   Levin, Victor A ^a   Conrad, Charles A ^a   Hsu, Sigmund H ^a   Colman, Howard ^a   De Groot, John F ^a   Ritterhouse, Melesa G ^a   Ictech, Sandra E ^a   Yung, W K Alfred ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b UNIVERSITY OF TEXAS   (United States)

Author keywords

Angiogenesis; Combination chemotherapy; Glioblastoma multiforme; Progression free survival

Indexed keywords

CARMUSTINE; CYTOTOXIC AGENT; ERLOTINIB; GEFITINIB; IRINOTECAN; ISOTRETINOIN; LOMUSTINE; PEG INTERFERON; PROCARBAZINE; TEMOZOLOMIDE; THALIDOMIDE; TIPIFARNIB; UNCLASSIFIED DRUG; VINCRISTINE; WARFARIN; ANTINEOPLASTIC AGENT; CAMPTOTHECIN; DRUG DERIVATIVE;

ABDOMINAL CRAMP; ABDOMINAL PAIN; ADULT; AGED; AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; BONE MARROW TOXICITY; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; DEHYDRATION; DIARRHEA; DIZZINESS; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; ELECTROLYTE DISTURBANCE; FATIGUE; FEMALE; GLIOBLASTOMA; HEADACHE; HUMAN; HYPERGLYCEMIA; LYMPHOCYTOPENIA; MALE; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; RECURRENT CANCER; RELAPSE; SIDE EFFECT; SURVIVAL RATE; SURVIVAL TIME; TOXICITY; BRAIN TUMOR; DISEASE FREE SURVIVAL; KAPLAN MEIER METHOD; MIDDLE AGED; NUCLEAR MAGNETIC RESONANCE IMAGING; TUMOR RECURRENCE;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BRAIN NEOPLASMS; CAMPTOTHECIN; DISEASE-FREE SURVIVAL; FEMALE; GLIOBLASTOMA; HUMANS; KAPLAN-MEIERS ESTIMATE; MAGNETIC RESONANCE IMAGING; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; THALIDOMIDE;

EID: 44849144705     PISSN: 15228517     EISSN: 15235866     Source Type: Journal    
DOI: 10.1215/15228517-2007-060     Document Type: Article

References (30)

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. Puduvalli VK. Inhibition of angiogenesis as a therapeutic strategy against brain tumors. Cancer Treat Res. 2004;117:307-336.
3. Tong RT, Boucher Y, Kozin SV, et al. Vascular normalization by vascular endothelial growth factor receptor 2 blockade induces a pressure gradient across the vasculature and improves drug penetration in tumors. Cancer Res. 2004;64:3731-3736.
4. Nakatsu S, Kondo S, Kondo Y, et al. Induction of apoptosis in multidrug resistant (MDR) human glioblastoma cells by SN-38, a metabolite of the camptothecin derivative CPT-11. Cancer Chemother Pharmacol. 1997;39:417-423.
5. Buckner JC, Reid JM, Wright K, et al. Irinotecan in the treatment of glioma patients: current and future studies of the North Central Cancer Treatment Group. Cancer. 2003;97:2352-2358.
6. Reardon DA, Friedman HS, Powell JB Jr, et al. Irinotecan: promising activity in the treatment of malignant glioma. Oncology (Williston Park). 2003;17:9-14.
7. Sandmeier D, Chaubert P, Bouzourene H. Irinotecan-induced colitis. Int J Surg Pathol. 2005;13:215-218.
8. Govindarajan R. Irinotecan and thalidomide in metastatic colorectal cancer. Oncology (Williston Park). 2000;14:29-32.
9. Govindarajan R, Heaton KM, Broadwater R, et al. Effect of thalidomide on gastrointestinal toxic effects of irinotecan. Lancet. 2000;356: 566-567.
10. Short SC, Traish D, Dowe A, et al. Thalidomide as an anti-angiogenic agent in relapsed gliomas. J Neurooncol 2001;51:41-45.
11. Fine HA, Figg WD, Jaeckle K, et al. Phase II trial of the antiangiogenic agent thalidomide in patients with recurrent high-grade gliomas. J Clin Oncol. 2000;18:708-715.
12. Marx GM, Pavlakis N, McCowatt S, et al. Phase II study of thalido-mide in the treatment of recurrent glioblastoma multiforme. J Neu-rooncol. 2001;54:31-38.
13. Kuhn JG. Influence of anticonvulsants on the metabolism and elimination of irinotecan: a North American Brain Tumor Consortium preliminary report. Oncology (Williston Park) 2002;16:33-40.
14. Ikhlaque N, Seshadri V, Kathula S, et al. Efficacy of prophylactic warfarin for prevention of thalidomide-related deep venous thrombosis. Am J Hematol. 2006;81:420-422.
15. Macdonald DR, Cascino TL, Schold SC Jr, et al. Response criteria for phase II studies of supratentorial malignant glioma. J Clin Oncol. 1990;8:1277-1280.
16. Wong ET, Hess KR, Gleason MJ, et al. Outcomes and prognostic factors in recurrent glioma patients enrolled onto phase II clinical trials. J Clin Oncol. 1999;17:2572-2578.
17. 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.
18. 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.
19. Prados MD, Lamborn K, Yung WK, et al. A phase 2 trial of irinotecan (CPT-11) in patients with recurrent malignant glioma: a North American Brain Tumor Consortium study. Neuro-oncol. 2006; 8:189-193.
20. 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. Neuro-oncol. 2004;6:21-27.
21. Reardon DA, Quinn JA, Rich JN, et al. Phase 2 trial of BCNU plus irinotecan in adults with malignant glioma. Neuro-oncol. 2004;6:134-144.
22. Brandes AA, Tosoni A, Basso U, et al. Second-line chemotherapy with irinotecan plus carmustine in glioblastoma recurrent or progressive after first-line temozolomide chemotherapy: a phase II study of the Gruppo Italiano Cooperativo di Neuro-Oncologia (GICNO). J Clin Oncol. 2004;22:4779-4786.
23. Gilbert MR, Wen P, Lieberman F, et al. Phase I/II study of combination temozolomide (TMZ) and irinotecan (CPT-11) for recurrent malignant gliomas: a North American Brain Tumor Consortium (NABTC) study [abstract]. Proc Am Soc Clin Oncol. 2003: 410.
24. Gruber ML, Buster WP. Temozolomide in combination with irinote-can for treatment of recurrent malignant glioma. Am J Clin Oncol. 2004;27:33-38.
25. Groves MD, Puduvalli VK, Chang SM, et al. A North American Brain Tumor Consortium (NABTC 99-04) phase II trial of temozolomide plus thalidomide for recurrent glioblastoma multiforme. J Neurooncol. 2007;81:271-277.
26. Zangari M, Anaissie E, Barlogie B, et al. Increased risk of deep-vein thrombosis in patients with multiple myeloma receiving thalidomide and chemotherapy. Blood. 2001;98:1614-1615.
27. Marras LC, Geerts WH, Perry JR. The risk of venous thromboem-bolism is increased throughout the course of malignant glioma: an evidence-based review. Cancer. 2000; 89: 640-646.
28. Brandes AA, Scelzi E, Salmistraro G, et al. Incidence of risk of throm-boembolism during treatment high-grade gliomas: a prospective study. Eur J Cancer. 1997;33:1592-1596.
29. Gilbert MR, Supko JG, Batchelor T, et al. Phase I clinical and phar-macokinetic study of irinotecan in adults with recurrent malignant glioma. Clin Cancer Res. 2003;9:2940-2949.
30. Fine HA, Kim L, Royce C, Duic JP, Cohen LJ, Mitchell S. A phase I trial of CC-5103, a potent thalidomide analog, in patients with recurrent high-grade gliomas and other refractory CNS malignancies [abstract]. Proc Am Soc Clin Oncol. 2003:22.