Study 12 of 327 for search of: "Gliosarcoma"
Previous Study Return to Search Results Next Study

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Ph II Bevacizumab + Etoposide for Pts w Recurrent MG
This study is currently recruiting participants.
Verified by Duke University, November 2008
Sponsors and Collaborators: Duke University
Genentech
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00612430
  Purpose

Primary Objective to estimate 6-month progression free survival probability of pts w recurrent malignant glioma treated w Etoposide + bevacizumab.

Secondary Objectives To evaluate safety & tolerability of Etoposide + bevacizumab among pts w recurrent malignant glioma.

To evaluate radiographic response, progression free survival & overall survival of pts w recurrent malignant glioma treated w Etoposide + bevacizumab.


Condition Intervention Phase
Glioblastoma
Gliosarcoma
Drug: Bevacizumab and Etoposide
Phase II

Drug Information available for: Etoposide Bevacizumab Etoposide phosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: Phase II Trial of Bevacizumab Plus Etoposide for Patients With Recurrent Malignant Glioma

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 6 mth progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • a.Radiographic response. b.Median progression free survival and overall survival. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Gr 3 or greater, treatment related, non-hematologic toxicities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 59
Study Start Date: March 2007
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bevacizumab and Etoposide
    32 pts w recurrent WHO grade III MG & 27 pts w recurrent WHO grade IV MG will be enrolled in this study. Estimated rate of accrual is 10 pts per month. The estimated date of study completion is 6-9 months from study initiation. Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If pt tolerates 1st bevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day. The Duke investigators will review all la data & order treatment. Treatment will continue until either evidence of progressive disease, unacceptable toxicity, non-compliance w study follow-up, or withdrawal of consent.
Detailed Description:

Exploratory, single-arm, ph II study designed to assess anti-tumor activity of combinatorial regimen consisting of Etoposide + bevacizumab among pts w RMG. Primary endpoint of study is probability of progression-free survival at 6 mths. Important secondary objective is to further assess safety of Etoposide & bevacizumab for pts w RMG.

If study demonstrates that combinatorial regimen of Etoposide + bevacizumab is associated w encouraging anti-tumor activity among pts w RMG, further assessment of regimen in additional ph II & possibly ph III studies, will be considered.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 <past year
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00612430

Contacts
Contact: David A. Reardon, MD (919) 668-1409 david.reardon@duke.edu
Contact: Julie Norfleet (919) 684-8491 julie.norfleet@duke.edu

Locations
United States, North Carolina
Duke University Health System Recruiting
Durham, North Carolina, United States, 27710
Contact: David A. Reardon, MD     919-668-1409     david.reardon@duke.edu    
Contact: Julie Norfleet     (919) 684-8491     julie.norfleet@duke.edu    
Sponsors and Collaborators
Duke University
Genentech
Investigators
Principal Investigator: David A. Reardon, MD Duke University Health System
  More Information

The Preston Robert Tisch Brain Tumor Center at DUKE  This link exits the ClinicalTrials.gov site

Responsible Party: Duke University Health System ( David A. Reardon, MD )
Study ID Numbers: 00000379
Study First Received: January 29, 2008
Last Updated: November 13, 2008
ClinicalTrials.gov Identifier: NCT00612430  
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Gliosarcoma
Glioblastoma
GBM
MG
Brain tumor
Bevacizumab
Avastin
Etoposide
VP-16
Etopophos
Toposar
VePesid
Glioblastoma multiforme
Recurrent GBM
Anaplastic astrocytoma
Malignant glioma

Study placed in the following topic categories:
Glioblastoma
Astrocytoma
Bevacizumab
Etoposide phosphate
Recurrence
Brain Neoplasms
Neuroectodermal Tumors
Glioblastoma multiforme
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Gliosarcoma
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Neoplasms, Neuroepithelial
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009