brain tumor recurrent glioblastoma multiforme
Conditions
Interventions
Bevacizumab at a dose of 10 mg/kg body weight i.v. in 90 min on day 1 is given
every 2 weeks in cycles of 6 weeks. 89Zr-RO5323441 will be administered i.v. at
a tracer dose of 5 mg (37 MBq) on day -
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 89Zr-RO5323441 tumor uptake and organ distribution will be scored visually and quantitatively. Standardized uptake value (SUV) and relative uptake value (RUV) will be determined and compared in the recurrent GBM lesions and in relevant tissues at baseline and day 15. | — |
Secondary
| Measure | Time frame |
|---|---|
| - | — |
Countries
Netherlands
Outcome results
None listed