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

Primary Purpose

Glioblastoma, Astrocytoma

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bevacizumab/Irinotecan
Sponsored by
Clinical Research Center for Solid Tumor, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Glioblastoma, Astrocytoma, Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bevacizumab/Irinotecan

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Objective response rate
Overall survival
Disease-control rate
Adverse event

Full Information

First Posted
June 13, 2009
Last Updated
December 3, 2013
Sponsor
Clinical Research Center for Solid Tumor, Korea
Collaborators
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00921167
Brief Title
A Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Gliomas
Official Title
A Phase II Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Anaplastic Astrocytoma or Recurrent Glioblastoma Multiforme
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinical Research Center for Solid Tumor, Korea
Collaborators
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Astrocytoma
Keywords
Glioblastoma, Astrocytoma, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab/Irinotecan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bevacizumab/Irinotecan
Intervention Description
Bevacizumab 10mg/kg D1 Irinotecan 125mg/m2 D1 (without enzyme-inducing antiepileptic drugs [EIAEDs] or 340mg/m2 for patients on EIAEDs) every 2 weeks
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
6 months, 1 year
Secondary Outcome Measure Information:
Title
Objective response rate
Time Frame
6 weeks, 12 weeks
Title
Overall survival
Time Frame
6 months, 1 year
Title
Disease-control rate
Time Frame
6 weeks, 12 weeks
Title
Adverse event
Time Frame
3 weeks, 6 weeks, 9 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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