Bevacizumab Beyond Progression (BBP)

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT01740258
Phase
PHASE2
Status
Completed

Conditions

  • Glioblastoma
  • Gliosarcoma
  • Grade 4 Malignant Glioma
  • Malignant Glioma

Eligibility Criteria

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

Interventions

  • Radiation Therapy — RADIATION
  • Temozolomide — DRUG
  • Bevacizumab — DRUG

Study Details

Studies which have separately studied bevacizumab for recurrent gliomas and bevacizumab for newly-diagnosed glioma have shown good results and the regimens have been well-tolerated by patients. This study seeks to investigate the use of bevacizumab with the standard therapy (radiation therapy and temozolomide) in newly diagnosed patients, followed by bevacizumab and temozolomide with the continuation of bevacizumab following progression. Two critical questions remain- the role of bevacizumab maintenance and bevacizumab at the time of progression in a patient previously treated with bevacizumab at the time of initial diagnosis.

Key Dates

First listed
Dec 4, 2012
Start date
Jan 31, 2013
Status verified
Jan 2021
Primary completion
Nov 14, 2019
Completion
Nov 14, 2019

Study Design

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

Arms

  • Experimental: Bevaczimab, Radiation Therapy, Temozolomide
    In Part A, newly-diagnosed patients with Grade 4 malignant gliomas will receive standard radiation therapy, daily Temodar 75mg/M for 6-8 weeks. Bevacizumab will be given concurrently with radiation therapy and Temodar, 10 mg/kg every two weeks. If they are stable at the end of Part A, they will continue to Part B. In Part B patients will receive up to 12 cycles of bevacizumab and Temodar. Bevacizumab will be given on Days 1 and 15 of a 28-day cycle. Temodar will be 200 mg/meter squared daily for 5 days (days 1-5) of each cycle. If they have not progressed, patients will start Part C. In Part C, patients will receive bevacizumab 10mg/kg approximately every 2 weeks or 15 mg/kg approximately every 3 weeks. If patients progress during Part B or C, they will start Part D. In Part D, patients will receive bevacizumab-based therapy containing bevacizumab in combination with a chemotherapy and/or biologic agent, as determined by the Duke treating physician.

Primary Outcome Measure

Overall Survival [ Time Frame: 5 Years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Cancer CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Duke Cancer Center· Durham, NC

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