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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00921167
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Clinical Research Center for Solid Tumor, Korea
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries Korea, Republic of
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, Astrocytoma
Arms & Interventions

Arms

Experimental: Bevacizumab/Irinotecan

Interventions

Drug: - 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Address

Seoul National University Hospital

Seoul, ,

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