At a glance
ClinicalIndex Comparison Record- ✓Primary CNS lymphoma that is B-cell, CD20 antigen positive, confirmed by biopsy or CSF/vitreous cytology with monoclonal lymphocytic population
- ✓Life expectancy at least 8 weeks
- ✓Age ≥18 years
- ✓Zubrod performance status 0–2
- ✕Evidence of systemic lymphoma
- ✕Prior malignancy within 5 years (except in situ cervical carcinoma or non-melanomatous skin cancer)
- ✕Prior radiotherapy to brain or head/neck
- ✕Prior chemotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Study Of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, And Temozolomide And Post -Irradiation Temozolomide For Primary Central Nervous System Lymphoma
In Brief
A Phase 2 clinical trial evaluating rituximab, methotrexate, and 5 other interventions for Brain and Central Nervous System Tumors and Lymphoma. Completed, enrolled 60 participants across 26 sites.
Detailed Summary
RATIONALE: Drugs used in chemotherapy such as methotrexate and temozolomide use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining methotrexate, temozolomide, and rituximab with radiation therapy may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide when given together with methotrexate and rituximab followed by radiation therapy and to see how well they work in treating patients with primary central nervous system lymphoma.
Study Details
Timeline
Interventions
375 mg/m2, intravenously three days prior to the first cycle of methotrexate
Five cycles of methotrexate (MTX) at 3.5 gm/m2 administered every two weeks on weeks 1, 3, 5, 7, and 9 via intravenous infusion over four hours once per cycle. Calcium leucovorin 25 mg orally or intravenously every six hours initiated exactly 24 hours following the start of the MTX infusion. Methotrexate levels to be monitored daily, and calcium leucovorin discontinued when the MTX level is less than 10 micromolar.
Temozolomide 100 mg/m\^2 by mouth per day for five days on weeks 4 and 8.
Temozolomide 150 mg/m\^2 by mouth per day for five days on weeks 4 and 8.
Temozolomide 200 mg/m\^2 per day by mouth for five days on weeks 4 and 8.
Whole brain irradiation (WBRT) during weeks 11, 12, and 13, five days per week (excluding weekends). A daily dose of 2.4 Gy delivered in two fractions of 1.2 Gy each with a minimum inter-fraction interval of 6 hours, with a total dose to brain and meninges of 36 Gy.
Temozolomide (TMZ) 200 mg/m\^2 by mouth per day for 5 days on weeks 14, 18, 22, 26, 30, 34, 38, 42, 46, and 50 for a total of 10 cycles.