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

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glioblastoma; Gliosarcoma

Intervention: Temo + Avastin (Drug); VP-16 + Avastin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
David A. Reardon, MD, Principal Investigator, Affiliation: Duke University Health System

Summary

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

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

Radiographic Response

Median Progression-free Survival (PFS)

Median Overall Survival (OS)

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

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Pts have confirmed diagnosis of GBM & radiographic evidence of recurrence following

prior therapy w bev + irinotecan

- Age >18 yrs

- Interval of >4 wks between prior surgical resection/1 week from stereotactic biopsy

- Interval of >12 wks from end of prior external beam radiation therapy (XRT) unless

there is new area of enhancement consistent w recurrent tumor outside of XRT field,/there are progressive changes on MRI on >2 consecutive MRI scans >4wks apart, /there is biopsy-proven tumor progression

- Interval of >4 wks from prior chemo / investigational agent unless pt has recovered

from all anticipated toxicities associated w that therapy.

- Eastern Cooperative Oncology Group (ECOG) 0-1

- Hematocrit >29percent, absolute neutrophil count (ANC)>1,000 cells/ml l, platelets >

100,000 cells/ml l

- Serum creatinine<1. 5 mg/dl, serum glutamate oxaloacetate transaminase (SGOT) &

bilirubin<1. 5 times upper limit of normal (ULN)

- Signed informed consent approved by Institutional Review Board (IRB) prior to pt

entry

- No evidence of hemorrhage on baseline MRI/CT scan other than those that are stable

gr1

- If sexually active, pts will take contraceptive measures for duration of treatments

Exclusion Criteria:

- Co-medication that may interfere w study results

- Active infection requiring intravenous antibiotics

- Progression to daily etoposide/progression to daily temo

- Gr3/greater toxicity related to prior bev therapy,/prior temozolomide/etoposide

- Requires therapeutic anti-coagulation with warfarin.

- Inability to comply w study and/or follow-up procedures

- Current, recent,/planned participation in experimental drug study other than

Genentech-sponsored bev cancer study

- Inadequately controlled hypertension

- Any prior history of hypertensive crisis/hypertensive encephalopathy

- New York Heart Association (NYHA) Gr II/greater congestive heart failure

- History of myocardial infarction (MI)/unstable angina within 6 mths prior to study

enrollment

- History of stroke/transient ischemic attack within 6 mths prior to study enrollment

- Significant vascular disease

- Symptomatic peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days

prior to study enrollment or anticipation of need for major surgical procedure during the course of the study

- Core biopsy or other minor surgical procedure, excluding placement of a vascular

access device, within 7 days prior to study enrollment

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal

abscess within 6 months prior to study enrollment

- Serious, non-healing wound, ulcer, or bone fracture

- Proteinuria at screening as demonstrated by either:

- urine protein: creatinine (UPC) ratio >1. 0 at screening /

- Urine dipstick for proteinuria ≥ 2+

- Known hypersensitivity to any component of bevacizumab

- Pregnant or lactating. Use of effective means of contraception in subjects of

child-bearing potential

Locations and Contacts

Duke University Health System, Durham, North Carolina 27710, United States
Additional Information

The Preston Robert Tisch Brain Tumor Center at DUKE

Starting date: April 2008
Last updated: July 10, 2013

Page last updated: August 23, 2015

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