89Zr-RO5323441 PET imaging in patients with recurrent glioblastoma treated with bevacizumab
- Conditions
- brain tumorrecurrent glioblastoma multiforme10029211
- Registration Number
- NL-OMON37750
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 7
• 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.
• 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>89Zr-RO5323441 tumor uptake and organ distribution will be scored visually and<br /><br>quantitatively. Standardized uptake value (SUV) and relative uptake value (RUV)<br /><br>will be determined and compared in the recurrent GBM lesions and in relevant<br /><br>tissues at baseline and day 15. </p><br>
- Secondary Outcome Measures
Name Time Method <p>-</p><br>