At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Randomized Study of Rituximab, Methotrexate, Procarbazine, Vincristine, and Cytarabine With and Without Low-Dose Whole-Brain Radiotherapy for Primary Central Nervous System Lymphoma
In Brief
A Phase 2 clinical trial evaluating Rituximab, Cytarabine, and 4 other interventions for Chemotherapeutic Agent Toxicity and 4 related conditions. Completed, enrolled 91 participants across 45 sites in 2 countries.
Detailed Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, vincristine sulfate, procarbazine hydrochloride, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill cancer cells. It is not yet know whether rituximab and combination chemotherapy are more effective when given with or without radiation therapy in treating patients with primary central nervous system lymphoma. PURPOSE: This randomized phase II trial studies how well giving rituximab and combination chemotherapy with or without radiation therapy works in treating patients with primary central nervous system lymphoma.
Study Details
Timeline
Interventions
One 28-day cycle = 500 mg/m\^2 intravenously on day 1 and day 5.
One 28-day cycle = 3 g/m\^2 intravenously on day 1 and day 2.
One 28-day cycle = 3.5 g/m\^2 intravenously (standard hydration/leucovorin support) on day 2.
One 28-day cycle = 100 mg/m\^2 orally on days 2-8.
One 28-day cycle = 1.4 mg/m\^2 intravenously, dose capped at 2.4mg, on day 2 and day 16.
Total dose of 2340 cGy administered as 13 daily fractions of 180 cGy over 3 weeks. Participants with progressive disease on magnetic resonance imaging (MRI) do not receive WBRT.