drugset / Trial / NCT00074165

Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen

NCT00074165

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, etoposide phosphate, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain tumor. Chemoprotective drugs such as sodium thiosulfate may protect normal cells from the side effects of carboplatin-based chemotherapy. Combining rituximab with chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in treating patients who have refractory or recurrent primary CNS lymphoma.

Timeline

Start
2003-01
Primary completion
2010-06
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 200 mg/m2 Other
Subject Cyclophosphamide Other / unclassified 330 mg/m2 Intravenous
Subject Cytarabine Small molecule 40 mg Intrathecal
Subject Etoposide Small molecule 200 mg/m2 Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous
Background Sodium Thiosulfate Diagnostic / imaging agent 16000 mg/m2 Intravenous
Background Sodium Thiosulfate Diagnostic / imaging agent 20000 mg/m2 Intravenous
Background filgrastim Protein / enzyme biologic Subcutaneous