89Zr-RO5323441 PET scan in patients with recurrent high grade brain tumor treated with bevacizumab

• Conditions: Recurrent malignant glioma; MedDRA version: 14.0Level: PTClassification code 10065443Term: Malignant gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-004974-27-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-28
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Age = 18 years
•WHO Performance status 0 - 2
•Histologically or biopsy proven glioblastoma at recurrence
•Patients treated with one line of systemic chemotherapy (combined treatment with temozolomide/ RT followed by 6 cycles of temozolomide is considered as one line of systemic chemotherapy).
•Adequate hematological functions: Neutrophils = 1.5 x 109 cells/L, platelets = 100 x 109 cells/L, Hb = 6.2 mmol/L
•Adequate liver function: Bilirubin < 1.5 x upper limit of the normal range (ULN), alkaline phosphatase and transaminases (ASAT/ALAT) < 2.5 x ULN, INR < 1.5
•Adequate renal function:
- Serum creatinine increased ? 3x ULN or/and Calculated (Cockcroft-Gault) or measured creatinine clearance > 30 mL/min
- Urine dipstick for proteinuria < 2+. Patients with = 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hrs urine collection and must demonstrate = 1 g of protein/24 hr
•Women of reproductive potential, female patients within one year of entering the menopause as well as males must agree to use an effective non-hormonal method of contraception during the treatment period and for at least 6 months after the last dose of bevacizumab
•Patients must be able to give written informed consent to participate.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

•Last surgical procedure (including biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) < 28 days prior to start study treatment
•Current or recent (within 4 weeks of enrolment) treatment with another investigational drug or participation in another investigational study
•No radiotherapy within the 1 months prior to the diagnosis of progression
•No chemotherapy in the past 4 weeks
•Arterial or venous thrombosis = 6 months prior to registration
•History of myocardial infarction (= 6 months prior to inclusion), unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring digoxin treatment
•Uncontrolled hypertension defined by a systolic blood pressure (BP) > 140 mm Hg and/or diastolic pressure > 100 mm Hg, with or without anti-hypertensive medication. Patients with initial blood pressure elevation are eligible if initiation or adjustment of anti-hypertensive medication lowers pressure to meet the entry criteria
•Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (> 325 mg/day) or other NSAID with anti-platelet activity or treatment with dipyramidole, ticlopidine, clopidogrel and cilostaz
•Use of therapeutic-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes
•Clinically serious (as judged by the investigator) non-healing wounds, active skin ulcers or incompletely healed bone fracture
•Evidence of any active infection requiring hospitalization or antibiotics, within 2 weeks prior to day 1 of cycle 1
•Known hypersensitivity to any part of the bevacizumab formulation
•No geographical, psychological or other non-medical conditions interfering with follow-up
•Pregnant or lactating females. Serum pregnancy test to be assessed before entry in the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified