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Ph II Bevacizumab + Etoposide for Pts w Recurrent MG

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: Bevacizumab and Etoposide (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 patients with recurrent malignant glioma treated with Etoposide + Bevacizumab. Secondary Objectives To evaluate safety & tolerability of Etoposide + Bevacizumab among patients with recurrent malignant glioma (RMG). To evaluate radiographic response, progression free survival & overall survival of patients with recurrent malignant glioma treated with Etoposide + Bevacizumab.

Clinical Details

Official title: Phase II Trial of Bevacizumab Plus Etoposide for Patients With Recurrent Malignant Glioma

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 6 Month Progression-Free Survival (PFS)

Secondary outcome:

Objective Response Rate

Safety of Study Treatment Regimen

Median Progression-Free Survival

Median Overall Survival (OS)

Detailed description: Exploratory, single-arm, ph II study designed to assess anti-tumor activity of combinatorial regimen consisting of Etoposide + Bevacizumab among patients with RMG. Primary endpoint of study is probability of progression-free survival at 6 months. Important secondary objective is to further assess safety of Etoposide & Bevacizumab for patients with recurrent malignant glioma. If study demonstrates that combinatorial regimen of Etoposide + Bevacizumab is associated with encouraging anti-tumor activity among patients with RMG, further assessment of regimen in additional phase II & possibly phase III studies, will be considered.

Eligibility

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

Criteria:

Inclusion Criteria:

- Pts have confirmed diagnosis of recurrent/progressive WHO gr III & IV MG

- Age >18 rs

- Interval of >4 wks since prior surgery

- Interval of >4 wks since prior XRT/chemo, unless there is unequivocal evidence of

progressive disease & pts have recovered from all anticipated toxicity of most recent therapy;

- Karnofsky performance status score >60

- Hematocrit >29 percent, ANC >1,500 cells/microliter, platelets >100,000

cells/microliter

- Serum creatinine <1. 5 mg/dl, BUN <25 mg/dl, serum SGOT & bilirubin <1. 5 x ULN

- For pts on corticosteroids, they have been on astable dose for 1wk prior to entry

- Signed informed consent approved by IRB prior to pt entry

- If sexually active, pts must agree to take contraceptive measures for duration of

treatments. Exclusion Criteria:

- Prior therapy w either bevacizumab/etoposide

- >3 prior recurrences

- Pregnancy/breast feeding

- Co-medication w immuno-suppressive agents other than corticosteroids including but

not limited to cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil

- Evidence of CNS hemorrhage on baseline MRI on CT scan

- Pts who require therapeutic anti-coagulation

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active

infection requiring IV antibiotics & psychiatric illness/social situations that would limit compliance w study requirements, or disorders associated w significant immunocompromised state

- Pts w another primary malignancy that has required treatment

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: March 2007
Last updated: July 30, 2013

Page last updated: August 23, 2015

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