Bevacizumab and Irinotecan for Patients With Primary Brain Tumors and Progression After Standard Therapy

Sponsor
Rigshospitalet, Denmark
Study ID
NCT00463203
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    10 mg/kg every 2 weeks
  • Irinotecan — DRUG
    125 mg/m2 non-EIAED or 340 mg/m2 EIAED every 2 weeks

Study Details

Irinotecan has demonstrated activity in malignant gliomas in multiple phase II studies. The activity is limited, with an approximately 15 % response rate and a progression-free survival of 3-5 months. Given the synergy between irinotecan and bevacizumab in colorectal cancer, and the high-level expression of vascular endothelial growth factor on malignant gliomas, one would expect synergy between bevacizumab and irinotecan against gliomas. Recent data form a small study of 32 patients from Duke University have achieved a response rate of 62% in patients with malignant gliomas. Most included patients had glioblastomas, but this regimen may also have activity in more rare primary malignant brain tumors. The investigators therefore plan to include other primary malignant brain tumors in this study, and the clinical activity will be correlated with biomarkers and PET results of metabolic activity and blood flow. This may result in information that can be used to individualize therapy in the future.

Key Dates

Start date
Mar 31, 2007
Status verified
Jun 2011
Primary completion
Mar 31, 2011
Completion
Jun 30, 2011

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

progression-free survival [ Time Frame: 6 months ]

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