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Phase 2
18 Years
Not Enrolling
Brain Neoplasms, Glioma

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Trial Information

Inclusion 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression-free survival

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Ulrik Lassen, MD., PH.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rigshospitalet, Dept. of Oncology


Denmark: Danish Medicines Agency

Study ID:




Start Date:

March 2007

Completion Date:

June 2011

Related Keywords:

  • Brain Neoplasms
  • Glioma
  • primary malignant brain tumor
  • grade II glioma
  • meningeoma
  • ependymoma
  • Recurrence or progression after standard treatment
  • Brain Neoplasms
  • Neoplasms
  • Glioma