RT, Temozolomide, and Bevacizumab Followed by Bevacizumab/Everolimus in First-line Treatment of GBM

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT00805961
Phase
PHASE2
Status
Completed

Conditions

  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiation therapy — RADIATION
    Radiation therapy, 2.0 Gy daily, 5 days per week by single daily dose, to a total of 60 Gy over 6 weeks
  • Temozolomide — DRUG
    Temozolomide 75mg/m2 by mouth daily, beginning day 1 of radiation therapy and continuing through the last day of radiation therapy
  • Bevacizumab — DRUG
    Bevacizumab 10mg/kg IV, every 2 weeks, beginning day 1 of radiation therapy
  • Bevacizumab — DRUG
    Bevacizumab 10mg/kg IV, every 2 weeks, beginning Week 11
  • Everolimus — DRUG
    Everolimus 10mg by mouth daily, beginning Week 11

Study Details

In this phase II trial the investigators plan to incorporate two targeted agents, bevacizumab and everolimus, into the first-line multimodality therapy of glioblastoma. In the first portion of the treatment, bevacizumab will be added to standard concurrent radiation therapy plus temozolomide. After completing radiation therapy, patients will continue treatment with the combination of bevacizumab and everolimus.

Key Dates

First listed
Dec 10, 2008
Start date
Jan 31, 2009
Status verified
Nov 2021
Primary completion
Oct 31, 2009
Completion
May 31, 2013

Study Design

Enrollment
68 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention
    Combined Modality Treatment and Systemic Therapy Combined Modality Therapy - Radiation Therapy: 2 Gy/fraction, single daily fractions Monday-Friday, to total of 60 Gy Temozolomide: 75 mg/m2 by mouth daily Bevacizumab: 10 mg/kg IV every 2 weeks (Weeks 1, 3, 5, and 7) After the last dose of radiation, patients exhibiting an objective response, stable disease on MRI scan, or have stable/improved tumor-related symptoms will begin systemic therapy Systemic Therapy - Bevacizumab: 10 mg/kg IV every 2 weeks Everolimus: 10 mg by mouth daily

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: 18 months ]

Locations (13)

FacilityCityStateZIPSite coordinators
Clearview Cancer InstituteHuntsvilleAlabama35805-
Florida Cancer SpecialistsFort MyersFlorida33901-
Northeast Georgia Medical CenterGainesvilleGeorgia30501-
Consultants in Blood Disorders and CancerLouisvilleKentucky40207-
Center for Cancer and Blood DisordersBethesdaMaryland20817-
Grand Rapids Clinical Oncology ProgramGrand RapidsMichigan49503-
St. Louis Cancer CareChesterfieldMissouri63017-
Research Medical CenterKansas CityMissouri64132-
Methodist Cancer CenterOmahaNebraska68114-
South Carolina Oncology Associates, PAColumbiaSouth Carolina29210-
Tennessee Oncology, PLLCNashvilleTennessee37023-
Peninsula Cancer InstituteNewport NewsVirginia23601-
Virginia Cancer InstituteRichmondVirginia23235-

Find similar trials in Huntsville, AL

By research site
Clearview Cancer Institute· Huntsville, ALFlorida Cancer Specialists· Fort Myers, FLNortheast Georgia Medical Center· Gainesville, GAConsultants in Blood Disorders and Cancer· Louisville, KYCenter for Cancer and Blood Disorders· Bethesda, MDGrand Rapids Clinical Oncology Program· Grand Rapids, MI

Related Studies