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

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

Official Title
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A Phase II Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Anaplastic Astrocytoma or Recurrent Glioblastoma Multiforme

Conditions
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Glioblastoma, Astrocytoma

Intervention / Treatment
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* Drug: Bevacizumab/Irinotecan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab/Irinotecan<br> | Drug: Bevacizumab/Irinotecan<br>* Bevacizumab 10mg/kg D1 Irinotecan 125mg/m2 D1 (without enzyme-inducing antiepileptic drugs [EIAEDs] or 340mg/m2 for patients on EIAEDs) every 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 6 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glioblastoma, Astrocytoma, Chemotherapy