Astrocytoma, Glioblastoma
Conditions
Keywords
Glioblastoma, Astrocytoma, Chemotherapy
Brief summary
To assess the efficacy and safety of bevacizumab plus irinotecan for the patients with recurrent anaplastic astrocytoma or with recurrent glioblastoma multiforme
Interventions
Bevacizumab 10mg/kg D1 Irinotecan 125mg/m2 D1 (without enzyme-inducing antiepileptic drugs \[EIAEDs\] or 340mg/m2 for patients on EIAEDs) every 2 weeks
Sponsors
Seoul National University Hospital
Clinical Research Center for Solid Tumor, Korea
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | 6 months, 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate | 6 weeks, 12 weeks |
| Overall survival | 6 months, 1 year |
| Disease-control rate | 6 weeks, 12 weeks |
| Adverse event | 3 weeks, 6 weeks, 9 weeks, 12 weeks |
Countries
South Korea
Outcome results
None listed