A Phase II Trial Involving Patients With Recurrent PCNSL Treated With Carboplatin/BBBD, by Adding Rituxan (Rituximab), An Anti CD-20 Antibody, To The Treatment Regimen
- Determine the efficacy of rituximab, carboplatin, cyclophosphamide, etoposide or
etoposide phosphate and cytarabine administered in conjunction with osmotic blood-brain
barrier disruption and high-dose sodium thiosulfate, in terms of complete response
rate, in patients with refractory or recurrent primary CNS lymphoma.
- Determine the overall survival and 2-year progression-free survival of patients treated
with this regimen.
- Determine the quality of life and cognitive function of patients treated with this
- Determine the neurotoxicity of this regimen in these patients.
- Determine the percentage of patients with ototoxicity over time after treatment with
- Determine the effect of delayed administration of sodium thiosulfate on granulocyte and
erythrocyte counts in these patients.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV on day 1. On days 2 and 3, patients receive carboplatin
intra-arterially over 10 minutes, cyclophosphamide IV over 10 minutes, and etoposide or
etoposide phosphate IV over 10 minutes in conjunction with blood-brain barrier disruption.
Patients also receive high-dose sodium thiosulfate IV over 15 minutes administered 4 and 8
hours after carboplatin on days 2 and 3 and intraventricular or intrathecal cytarabine on
day 14. Beginning 48 hours after the last dose of chemotherapy, patients receive filgrastim
(G-CSF)* subcutaneously (SC) daily for 7-10 days or until blood counts recover. Treatment
repeats every 4 weeks for up to 12 courses.
NOTE: * Alternatively, patients may receive a single dose of pegfilgrastim SC, administered
48 hours after the completion of chemotherapy
Patients with intraocular lymphoma also receive methotrexate intravitreally twice weekly
until the vitreous is clear of cells by slit lamp exam; once weekly for 1 month; and then
monthly for 1 year.
Quality of life is assessed at baseline, every 3 months during treatment, within 30 days of
final treatment, then every 6 months for 1 year, and then annually thereafter.
Patients are followed monthly for 3 months, every 2 months for 8 months, every 3 months for
1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 11-25 patients will be accrued for this study within 7-10
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With a Complete Response Rate to Chemotherapy Regimen Assessed by Radiographic Response at 2 Years.
Per RECIST criteria (v1.1) and assessed by magnetic resonance imaging (MRI): Complete response (CR), Disappearance of all target lesions.
Edward A. Neuwelt, MD
OHSU Knight Cancer Institute
United States: Institutional Review Board
|Knight Cancer Institute at Oregon Health and Science University||Portland, Oregon 97239-3098|
|Good Samaritan Hospital Cancer Treatment Center, Hatton Institute||Cincinnati, Ohio 45220|