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

NCT ID: NCT00921167

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-12-31

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

Detailed Description

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Conditions

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Glioblastoma Astrocytoma

Keywords

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Glioblastoma Astrocytoma Chemotherapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bevacizumab/Irinotecan

Group Type EXPERIMENTAL

Bevacizumab/Irinotecan

Intervention Type DRUG

Bevacizumab 10mg/kg D1 Irinotecan 125mg/m2 D1 (without enzyme-inducing antiepileptic drugs \[EIAEDs\] or 340mg/m2 for patients on EIAEDs) every 2 weeks

Interventions

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Bevacizumab/Irinotecan

Bevacizumab 10mg/kg D1 Irinotecan 125mg/m2 D1 (without enzyme-inducing antiepileptic drugs \[EIAEDs\] or 340mg/m2 for patients on EIAEDs) every 2 weeks

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role collaborator

Clinical Research Center for Solid Tumor, Korea

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CRCST-L-0006

Identifier Type: -

Identifier Source: org_study_id