Status:
COMPLETED
A Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Gliomas
Lead Sponsor:
Clinical Research Center for Solid Tumor, Korea
Collaborating Sponsors:
Seoul National University Hospital
Conditions:
Glioblastoma
Astrocytoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To assess the efficacy and safety of bevacizumab plus irinotecan for the patients with recurrent anaplastic astrocytoma or with recurrent glioblastoma multiforme
Eligibility Criteria
Inclusion
- Histologically diagnosed recurrent anaplastic astrocytoma or recurrent glioblastoma multiforme
- At least 18 years of age
- Performance status of 0 and 1 on the Eastern Cooperative Oncology Group (ECOG) criteria
- One or more measurable disease
- Adequate hematologic (neutrophil count \>= 1500/uL, platelets \>= 100,000/uL), hepatic (transaminase =\< upper normal limit (UNL)x2.5, bilirubin level =\< UNLx1.5, alkaline phosphatase =\< UNLx2.5), and renal (creatinine clearance \>= 30mL/min)
- Expected life time more than at least 2 months
- A patients who signed the informed consent prior to the participation in the study
Exclusion
- A pregnant or lactating patient
- A patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (A premenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
- A man or woman of childbearing potential without the willingness to use a contraceptive measures during the study
- A patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer
- Medically uncontrolled serious heart, lung, neurological, psychological, or metabolic disease
- Uncontrolled serious infection
- Enrollment in other study within 30 days
- Hemorrhage on baseline radiologic examination
- A patient who refused to sign the informed consent
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00921167
Start Date
June 1 2009
End Date
December 1 2013
Last Update
December 4 2013
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea