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RTOG 0913: A phase I study of daily everolimus (RAD001) in combination with radiation therapy and temozolomide in patients with newly diagnosed glioblastoma.

CNS Tumors

Central Nervous System Tumors

2013 ASCO Annual Meeting

Abstract No:

J Clin Oncol 31, 2013 (suppl; abstr 2047)

Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2013 Annual Meeting but not presented at the Meeting, can be found online only.

Author(s): Prakash Chinnaiyan, Minhee Won, Patrick Y. Wen, Amyn Rojiani, Merideth M Wendland, Thomas A. DiPetrillo, Benjamin W. Corn, Minesh P. Mehta; H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL; Radiation Therapy Oncology Group, Philadelphia, PA; Dana-Farber Cancer Institute, Boston, MA; Georgia Health Sciences University, Augusta, GA; Willamette Valley Cancer Institute, Eugene, OR; Department of Radiation Oncology, Rhode Island Hospital, Providence, RI; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of Maryland, Baltimore, MD

Abstract Disclosures


Background: To determine the safety of the mTOR inhibitor everolimus (RAD001) administered daily with concurrent radiation and temozolomide in newly diagnosed glioblastoma patients. Methods: Everolimus was administered daily with concurrent radiation (60 Gy in 30 fractions) and temozolomide (TMZ) (75 mg/m2/day). Everolimus was escalated from 2.5 (Dose Level 1), to 5 (Dose Level 2), to 10 mg/day (Dose Level 3). Maintenance TMZ was delivered at 150-200 mg/m2 on days 1 to 5 every 28 days for up to 12 cycles with concurrent everolimus at the previously established daily dose of 10 mg/day. Dose escalation continued if a dose level produced DLTs in ≤ 2 of the first 6 evaluable patients. Results: Between October 28, 2010 and July 2, 2012, the Radiation Therapy Oncology Group (RTOG) 0913 protocol initially registered a total of 35 patients, with 25 patients successfully meeting enrollment criteria, receiving drug and evaluable for toxicity. Everolimus was successfully escalated to the predetermined MTD of 10 mg/day. Two of the first 6 eligible patients experienced a DLT at each dose level. DLTs included: gait disturbance, febrile neutropenia, rash, fatigue, thrombocytopenia, hypoxia, ear pain, headache, and mucositis. Other common toxicities were Grade 1/2 hypercholesterolemia and hypertriglyceridemia. At the time of analysis, there was one death reported, which was attributed to tumor progression. Conclusions: Daily oral everolimus (10 mg) combined with both concurrent radiation therapy and TMZ followed by maintenance TMZ, is well tolerated, with an acceptable toxicity profile. A phase II randomized clinical trial with mandatory correlative biomarker analysis is currently underway, designed to both determine the efficacy of this regimen and identify molecular determinants of response. Supported by RTOG U10 CA21661 and CCOP U10 CA37422 grants from NCI and Novartis. Clinical trial information: NCT01062399.


  Other Abstracts in this Sub-Category:


1. RTOG 0825: Phase III double-blind placebo-controlled trial evaluating bevacizumab (Bev) in patients (Pts) with newly diagnosed glioblastoma (GBM).

Meeting: 2013 ASCO Annual Meeting Abstract No: 1 First Author: M. R. Gilbert
Category: Central Nervous System Tumors - CNS Tumors


2. Bevacizumab, irinotecan, and radiotherapy versus standard temozolomide and radiotherapy in newly diagnosed, MGMT-nonmethylated glioblastoma patients: First results from the randomized multicenter GLARIUS trial.

Meeting: 2013 ASCO Annual Meeting Abstract No: LBA2000 First Author: U. Herrlinger
Category: Central Nervous System Tumors - CNS Tumors


3. A randomized phase II study of bevacizumab versus bevacizumab plus lomustine versus lomustine single agent in recurrent glioblastoma: The Dutch BELOB study.

Meeting: 2013 ASCO Annual Meeting Abstract No: 2001 First Author: W. Taal
Category: Central Nervous System Tumors - CNS Tumors