A Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Gliomas

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy and safety of bevacizumab plus irinotecan for the patients with recurrent anaplastic astrocytoma or with recurrent glioblastoma multiforme

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinical Research Center for Solid Tumor, Korea
• Collaborator: Seoul National University Hospital
• Treatments: Bevacizumab; Camptothecin; Irinotecan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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