A Phase I/II Study of Patient With Newly Diagnosed Primary Central Nervous System Lymphoma Treated With Methotrexate/BBBD, and Adding Rituximab (an Anti CD-20 Antibody) and Carboplatin, to the Treatment Regimen
- Evaluate the safety and toxicities of rituximab in combination with blood-brain barrier
disruption with mannitol, combination chemotherapy comprising methotrexate and
carboplatin, and delayed sodium thiosulfate.
- Determine the effect of this regimen on complete response (CR) rate within the first 3
months of treatment in these patients.
- Estimate the overall CR response rate, the 2-year overall survival, and the 2-year
event-free survival of these patients.
OUTLINE: This is a multicenter, phase I/II study
- Patients receive rituximab IV over 5 hours on day 1 followed by blood-brain barrier
disruption comprising mannitol intra-arterially (IA) and combination chemotherapy
comprising methotrexate IA over 10 minutes and carboplatin IA over 10 minutes on days 2
and 3. Patients also receive sodium thiosulfate IV over 15 minutes twice on days 2 and
3 and filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 5 and
continuing for approximately 7-10 days or until blood counts recover OR pegfilgrastim
SC once on day 5. Patients with positive cerebrospinal fluid (CSF) cytology also
receive cytarabine via Ommaya reservoir or lumbar puncture on day 14. Patients with
ocular involvement also receive injections of methotrexate into the eye(s) twice a week
until the vitreous is clear of cancer cells and then once a week for 1 month and once a
month for up to 1 year.
- Quality of life is assessed at baseline, every 6 months during treatment, at completion
of treatment, and then every 3 months for 2 years, every 6 months for 3 years, and
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response rate
first 3 months of treatment
Edward A. Neuwelt, MD
Oregon Health and Science University
United States: Institutional Review Board
|Oregon Health and Science University||Portland, Oregon 97201|
|Good Samaritan Hospital, Hatton Institute||Cincinnati, Ohio 45220|