Remote effects of cancer
Conditions
Interventions
Natalizumab 300 mg, intravenous infusions q 4 weeks for a maximum of 3
infusions over 12 weeks.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - PEM/PSN associated with high titer (>=400) anti-Hu antibodies in serum or plasma - The neurological symptoms must still be progressing defined as neurological deterioration over the last 4 weeks - Score mRS >= 2 - Absolute CD4+ cell count >=400 x 109 cells per liter - Patients aged >=18 years - Patients who receive or will receive anti-tumor therapy are allowed to participate - Patients who have given written informed consent
Exclusion criteria
Exclusion criteria: - Patients who are unwilling to undergo lumbar puncture - Known hypersensitivity to natalizumab or one of the additives - Progressive multifocal leukoencephalopathy (PML) - Immune compromised patients (patients using immunosuppressive medications other than short course (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional improvement with one point or more on the modified Rankin scale after the 12th week of natalizumab (compared to baseline). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include neurological improvement and safety. Neurological improvement is defined as a positive score (>0) in the EFIT overall evaluation and improvement on the AMC linear disability scale, Barthel index and PNS neurological scale after three natalizumab infusions (the 12th week of natalizumab), compared to baseline. Safety is assessed by CTC AE 4.0 criteria, from date of registration until 12 weeks after last study drug administration. | — |
Countries
Netherlands
Outcome results
None listed