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Phase II Study of Rituximab Given in Conjunction With Standard Chemotherapy in Primary Central Nervous System (CNS) Lymphoma
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and 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, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with primary central nervous system (CNS) lymphoma.
OBJECTIVES: Primary * Determine the complete response rate. Secondary * Determine the progression-free survival of these patients. * Determine the proportion of progression-free and overall survival in these patients. * Determine rituximab cerebrospinal fluid pharmacokinetics (only in patients requiring intrathecal chemotherapy). OUTLINE: This is a multicenter study. Patients receive rituximab IV 3 times weekly in weeks 1-4; high-dose methotrexate IV over 2 hours in weeks 1, 3, 5, and 9; oral or IV leucovorin calcium every 6 hours for 12 doses beginning 24 hours after the start of methotrexate in weeks 1, 3, 5, and 9; vincristine IV in weeks 1, 3, 5, 7, and 9; oral procarbazine hydrochloride daily on days 1-7 in weeks 1, 5, and 9; oral dexamethasone daily in weeks 1-6; and cytarabine IV over 2 hours twice weekly in weeks 11 and 14. Patients with positive cerebrospinal fluid also receive methotrexate intrathecally and oral leucovorin calcium every 12 hours for 8 doses beginning 24 hours after the start of methotrexate in weeks 2, 4, 6, 8, and 10. After completion of study treatment, patients are followed periodically for 5 years. PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Stanford Cancer Center
Stanford, California, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States
McFarland Clinic, PC
Ames, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, United States
Hospital District Sixth of Harper County
Anthony, Kansas, United States
Start Date
August 23, 2007
Primary Completion Date
July 1, 2015
Completion Date
July 1, 2015
Last Updated
July 3, 2023
26
ACTUAL participants
Rituximab
BIOLOGICAL
Cytarabine
DRUG
Dexamethasone
DRUG
Leucovorin
DRUG
Methotrexate
DRUG
Procarbazine
DRUG
Vincristine
DRUG
Lead Sponsor
Eastern Cooperative Oncology Group
NCT07388563
NCT06337318
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