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

Clinical Research Center for Solid Tumor, Korea

Status and phase

Completed

Phase 2

Conditions

Glioblastoma

Astrocytoma

Treatments

Drug: Bevacizumab/Irinotecan

Study type

Interventional

Funder types

Other

Identifiers

NCT00921167

CRCST-L-0006

Details and patient eligibility

About

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

Enrollment

32 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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