Status:
COMPLETED
Bevacizumab and Irinotecan for Patients With Primary Brain Tumors and Progression After Standard Therapy
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Brain Neoplasms
Glioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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....
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00463203
Start Date
March 1 2007
End Date
June 1 2011
Last Update
June 29 2011
Active Locations (3)
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1
Aalborg University Hospital
Aalborg, Denmark, 9000
2
Rigshospitalet
Copenhagen, Denmark, 2100
3
Odense University Hospital
Odense, Denmark, 5000