Radioimmunotherapy with Lu-177 Labeled 6A10 Fab-fragments in Patients with Glioblastoma After Standard Treatment

Inclusion Criteria:

• Written patient consent after comprehensive information

• Age between 18 and 80 years

• Primary supratentorial high grade glioma after standard therapy (fluorescence-guidedsurgery, radio-chemotherapy, concomitant + adjuvant chemotherapy), with no or stablesmall tumor residue (residual contrast enhancement of up to 5cm3) at earliest 6weeks after completion of radiotherapy

• Histological verification of glioblastoma and CA 12-expression of tumor cellsconfirmed

• Karnofsky-score ≥ 60

• Volume of resection cavity 2,5-25 cm3

• Male and female patients with reproductive potential must use an approvedcontraceptive method

• Pre-menopausal female patients with childbearing potential: a negative serumpregnancy test must be obtained prior to treatment start

• Adequate bone marrow reserve: white blood cell (WBC) count ≥3000/μl, granulocytecount >1500/μl, platelets ≥100000/μl, hemoglobin ≥ 10 g/dl

• Adequate liver function: bilirubin < 1.5 times above upper limit of normal range (ULN), alanine transaminase (ALT/SGPT) and aspartate transaminase (AST/SGOT) < 3times ULN. In the case of documented or suspected Gilbert's disease bilirubin < 3times ULN.

• Blood clotting: INR (=PT) and PTT within acceptable limits according to theinvestigator

• Adequate renal function: creatinine < 3 times above ULN; eGFR > (or equal) 60 ml/min

Exclusion Criteria:

• Patient unable to undergo imaging by CT, PET or contrast-enhanced MRI for whateverreason (i.e., pacemaker)

• Resection cavity with intraventricular access

• Significant leakage of radioactivity into CSF spaces or ventricles

• Other actively treated invasive malignancy

• Breastfeeding women

• Past medical history of diseases with poor prognosis, e.g., severe coronary heartdisease, heart failure (NYHA III/IV), severe and poorly controlled diabetes, immunedeficiency, residual deficits after stroke, severe mental retardation, pre-existingneurological diseases except those related to glioblastoma or other seriousconcomitant systemic disorders incompatible with the study (at the discretion of theinvestigator)

• Any active infection (at the discretion of the investigator)

• Previous participation in a registered clinical trial with therapeutic interventionless than 6 weeks prior to enrolment (date of informed consent)

• Allergy against known constituents of study medication