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Bevacizumab and Irinotecan for Patients With Primary Brain Tumors and Progression After Standard Therapy

Study Purpose

Irinotecan has demonstrated activity in malignant gliomas in multiple phase II studies. The activity is limited, with an approximately 15 % response rate and a progression-free survival of 3-5 months. Given the synergy between irinotecan and bevacizumab in colorectal cancer, and the high-level expression of vascular endothelial growth factor on malignant gliomas, one would expect synergy between bevacizumab and irinotecan against gliomas. Recent data form a small study of 32 patients from Duke University have achieved a response rate of 62% in patients with malignant gliomas. Most included patients had glioblastomas, but this regimen may also have activity in more rare primary malignant brain tumors. The investigators therefore plan to include other primary malignant brain tumors in this study, and the clinical activity will be correlated with biomarkers and PET results of metabolic activity and blood flow. This may result in information that can be used to individualize therapy in the future.

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:

  • - Written informed consent.
  • - Histological verification of primary malignant brain tumor, or grade II glioma, meningeoma or ependymoma with progression and no other treatment options (including brain stem gliomas without histological verification) - Recurrence or progression after standard treatment (debulking surgery of possible, radiotherapy and for grade III or IV tumors temozolomide or other chemotherapy.
  • - Evidence of measurable recurrent progressive disease (CT/MRI scan) - An interval of at least 4 weeks between prior surgical resection and study enrollment.
  • - An interval of at least 4 weeks between prior radiotherapy or chemotherapy and enrollment on this protocol.
  • - PS 0-2 (ECOG scale) - Age > 18.
  • - Life expectancy > 3 month.
  • - Normal organ function: - Platelets > 125 x 109/l.
  • - Hemoglobin >6,2 mmol/l.
  • - Leukocytes > 3 x 109/l.
  • - ACN> 1,5 x 109/l.
  • - ASAT or ALAT < 3 x upper normal limit.
  • - Bilirubin < 1,5 x upper normal limit.
  • - Creatinine clearance > 45 ml/min.
  • - APTT < normal limit.
  • - INR < normal limit.
  • - Fertile females must use oral contraceptive, IUD (intrauterine device), gestagen sustained release injection, subdermal implantation, transdermal patch or hormonal vaginal ring.
This must continue at least three months after the patients is off-study. Fertile males must use preservatives.
  • - No sign of cerebral bleeding.

Exclusion criteria:

  • - Radiotherapy or chemotherapy within the last 4 weeks.
  • - Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids.
  • - Prior VEGF-based therapy.
  • - Any condition (medical, social, psychological), which would prevent adequate information and follow-up.
  • - Any other concurrent active malignancy, except, adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ.
  • - Any significant cardiac disease (New York Heart Association Class II or greater), arrhythmia, congestive heart failure, acute myocardial infarction within 6 months or unstable angina pectoris.
  • - Clinically significant peripheral vascular disease.
  • - Evidence of bleeding diathesis, coagulopathy or taking ASA, NSAIDs or clopidogrel.
  • - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0, anticipation of need for major surgical procedure during the curse of the study.
  • - Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0.
  • - History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 month prior to day 0.
  • - History of known HIV, Hepatitis B and Hepatitis C negative.
  • - Any ongoing infection, uncontrolled diabetes mellitus, serious non-healing wound, ulcer or bone fracture.
  • - Pregnancy or breast feeding.
  • - Requires therapeutic anti-coagulation.
  • - Blood pressure > 150/100 mmHG.
- Grade 2 or greater proteinuria

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.

 NCT00463203
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.

 Rigshospitalet, Denmark
Principal Investigator

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

 Ulrik Lassen, MD., PH.D.
Principal Investigator Affiliation Rigshospitalet, Dept. of Oncology
Agency Class

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

 Other
Overall Status Completed
Countries Denmark
Conditions

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

 Brain Neoplasms, Glioma

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

Aalborg University Hospital, Aalborg, Denmark

Status

Address

Aalborg University Hospital

Aalborg, , 9000

Rigshospitalet, Copenhagen, Denmark

Status

Address

Rigshospitalet

Copenhagen, , 2100

Odense University Hospital, Odense, Denmark

Status

Address

Odense University Hospital

Odense, , 5000

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