60
Participants
Start Date
July 31, 2003
Primary Completion Date
December 31, 2016
Study Completion Date
December 31, 2016
rituximab
375 mg/m2, intravenously three days prior to the first cycle of methotrexate
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
Temozolomide 100 mg/m\^2 by mouth per day for five days on weeks 4 and 8.
temozolomide 150 mg/m^2
Temozolomide 150 mg/m\^2 by mouth per day for five days on weeks 4 and 8.
temozolomide 200 mg/m^2
Temozolomide 200 mg/m\^2 per day by mouth for five days on weeks 4 and 8.
radiation therapy
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.
post-radiation therapy temozolomide
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.
Hollings Cancer Center at Medical University of South Carolina, Charleston
Integrated Community Oncology Network - Orange Park, Orange Park
Flagler Cancer Center, Saint Augustine
Florida Cancer Center - Palatka, Palatka
Baptist Cancer Institute - Jacksonville, Jacksonville
Integrated Community Oncology Network at Southside Cancer Center, Jacksonville
Integrated Community Oncology Network, Jacksonville Beach
Baptist Medical Center South, Jacksonville
Cleveland Clinic Taussig Cancer Center, Cleveland
Borgess Medical Center, Kalamazoo
Bronson Methodist Hospital, Kalamazoo
Community Memorial Hospital Cancer Care Center, Menomonee Falls
Medical College of Wisconsin Cancer Center, Milwaukee
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, St Louis
CCOP - Kansas City, Kansas City
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center, Murray
Utah Valley Regional Medical Center - Provo, Provo
CCOP - Nevada Cancer Research Foundation, Las Vegas
Providence Milwaukie Hospital, Milwaukie
CCOP - Columbia River Oncology Program, Portland
Providence St. Vincent Medical Center, Portland
Southwest Washington Medical Center Cancer Center, Vancouver
West Michigan Cancer Center, Kalamazoo
John F. Kennedy Medical Center, Edison
Providence Cancer Center at Providence Portland Medical Center, Portland
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia
Collaborators (1)
National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK