Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Glioblastoma

Brain Neoplasms

Gliosarcoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Irinotecan

Etoposide

Temozolomide

Etoposide phosphate

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients treated with bevacizumab + temozolomide

Patients treated with bevacizumab and VP-16 (etoposide)

Patients have progressed/had gr3/\> toxicity related to etoposide, with no had progression/gr 3/\> toxicity related to temozolomide, will only be considered for bevacizumab and temozolomide. Bevacizumab intravenously at dose 10mg/kg every other wk. For patients on bevacizumab and temozolomide, temozolomide administered on continuous dosing schedule at 50mg/m2/day.

Temo + Avastin

Patients have progressed/had gr3/\> toxicity related to temozolomide, but have not progressed/gr3/\> toxicity related to etoposide,considered only for bevacizumab and etoposide. Bevacizumab intravenously at dose 10mg/kg every other wk. Patients on bevacizumab and etoposide, etoposide once daily at 50mg/m2/day first 21 days of each 28-day cycle.

VP-16 + Avastin

David A. Reardon, MD

Primary objective To estimate 6-month progression free survival probability of pts w recurrent GBM treated w bev + either daily temozolomide/etoposide following progression on bev + irinotecan Secondary Objectives To evaluate safety \& tolerability of bev + either daily temozolomide/etoposide among pts w recurrent GBM who have progressed on bev + irinotecan To evaluate radiographic response, progression free survival \& overall survival of pts w recurrent GBM treated w bev + either daily temozolomide/etoposide following progression on bev + irinotecan

This is exploratory, two-arm, phase II study designed to assess anti-tumor activity of bev + either daily temozolomide/etoposide among GBM pts w progressive disease following bev + irinotecan. About 48 participants w recurrent GBM will take part in this study. Approximately 24 participants will receive bev plus temozolomide \& approximately 24 will receive bev + etoposide. Pts must have confirmed diagnosis of GBM \& radiographic evidence of recurrence following prior therapy bev + irinotecan. 24 pts will be enrolled onto each arm of this single-stage study. If 4 or more of these 24 pts live 6/more months without disease progression, treatment regimen will be considered worthy of further investigation. Otherwise, treatment regimen will be determined not worthy of further investigation within pt population. Type I \& II error rates associated w testing are 0.030 \& 0.115 respectively. Management guidelines dose reduction/interruption for temo, etoposide, \& bev.

Ph II Bev + Either Temozolomide/Etoposide for GBM Pts Who Have Failed Bev + Irinotecan

Phase II Study of Bevacizumab Plus Either Temozolomide or Etoposide for (GBM) Patients Who Have Failed Bevacizumab Plus Irinotecan

Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.

Percentage of participants with an objective response (complete response or partial response) based on modified Macdonald criteria.

Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.

Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.

Incidence of ≥Grade 3 treatment related, non-hematologic toxicity

Genentech, Inc.

Duke University

Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov

Temozolomide Arm

Etoposide Arm

Total

Age Continuous

Sex: Female, Male

The Primary Outcome Measure is 6 Month Progression-free Survival.

Radiographic Response

Median Progression-free Survival (PFS)

Median Overall Survival (OS)

Grade 3 or Greater, Treatment Related, Non-hematologic Toxicities.

Bevacizumab + Temozolomide: Patients who progressed or had grade 3 or greater toxicity related to prior daily etoposide dosing, but have not had prior progression or grade 3 toxicity related to prior daily temozolomide therapy. Patients who have not had prior progression or grade 3 or greater toxicity with either daily temozolomide or etoposide or who have no prior exposure to either will be randomized to one of the groups. Bevacizumab will be administered intravenously at 10mg/kg every other week. Temozolomide will be administered ona continuous daily dosing schedule at 50 mg/m\^2/day.

Bevacizumab + Etoposide: Patients who progressed or had grade 3 or greater toxicity related to prior daily temozolomide dosing, but have not had prior progression or grade 3 or greater toxicity related to prior daily etoposide therapy. Patients who have not had prior progression or grade 3 or greater toxicity with either daily temozolomide or etoposide or who have no prior exposure to either will be randomized to one of the groups. Bevacizumab will be administered intravenously at 10mg/kg every other week. Etoposide will be administered once daily at 50 mg/m\^2/day for the first 21 days of each 28-day cycle.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ph II Bev + Either Temozolomide/Etoposide for GBM Pts Who Have Failed Bev + Irinotecan	NCT00613028	Glioblastoma Gliosarcoma	Temo + Avastin VP-16 + Avastin	18 Years -	Duke University
Ph II Bev + Either Temozolomide/Etoposide for GBM Pts Who Have Failed Bev + Irinotecan	NCT00613028	Glioblastoma Gliosarcoma	Temo + Avastin VP-16 + Avastin	18 Years -	Duke University

Spots Global Cancer Trial Database for temo + avastin