Lymphoma Clinical Trial
Official title:
Phase I/II Study Of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, And Temozolomide And Post -Irradiation Temozolomide For Primary Central Nervous System Lymphoma
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.
OBJECTIVES:
- To assess the maximum tolerated dose (MTD) of temozolomide (TMZ) in combination with
methotrexate (MTX) and rituximab (RTX) when administered prior to twice daily
fractionated whole brain radiation therapy (WBRT) in patients with primary central
nervous system lymphoma.
- To compare the two-year survival rate in patients receiving pre-irradiation
chemotherapy, twice daily fractionated whole brain radiation therapy and
post-irradiation temozolomide to the reported two-year survival rate of Radiation
Therapy Oncology Group (RTOG) trial 93-10. RTOG 9310 does not fall within
ClinicalTrials.gov registration/reporting requirements.)
- To compare the pre-irradiation chemotherapy tumor response rates to the reported rate
from RTOG 93-10.
- To report progression-free survival.
- To assess acute and long-term neurologic toxicity, and to collect quality of life data
for this patient group.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
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