CNS Lymphoma
Trial overview
There is a clear need to optimise the delivery of MTX in patients with PCNSL to improve current therapy, allow treatment of older patients and inform trial development. It is hoped that the planned use of glucarpidase as described in this protocol will allow safer and more effective drug delivery and open up further possibilities for future studies of combined therapy for this disease.
Inclusion criteria
• Newly diagnosed, untreated PCNSL of diffuse large B-cell lymphoma histology
• Clinically considered eligible to receive standard 3g/m2 MTX if outside trial
• Age 18 or older
• GFR (initially measured by EDTA / isotope method) >=50ml/min
• ECOG Performance status 0-3Able to provide signed informed consent
• Patient must be willing to use appropriate contraception for the duration of treatment and six months after the cessation of methotrexate therapy
Exclusion criteria
• ECOG Performance status 4
• GFR < 50ml/min
• Clinically significant effusions or oedema
• Bilirubin>1.5 x normal upper limit
• HIV positive
• Dementia or neurological dysfunction not considered to be due to the PCNSL.
• Other serious or uncontrolled medical conditions
• Previous malignancy except adequately treated non-melanoma skin cancer or CIN
• Women who are pregnant or lactating (women of child bearing potential must have a negative pregnancy test before being registered in the study)
• Previous cytotoxic chemotherapy.