A Safety Study of Rituximab Plus MTX Injected Into the Cerebrospinal Fluid in the Treatment of Brain Lymphoma

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

January 31, 2012

Study Completion Date

March 31, 2013

Conditions
Central Nervous System LymphomaIntraocular Lymphoma
Interventions
DRUG

Intraventricular Rituximab Plus MTX

"Intraventricular injection of rituximab into an Ommaya reservoir on day 1 of each week. Intraventricular rituximab plus methotrexate (MTX) on day 4 of each week.~First three patients at dose A : 25 mg rituximab on day 1, and MTX (12 mg) plus rituximab (10 mg) on day 4 each week.~If there are no dose limiting toxicities at Dose A in all of the first 3 patients or in 5 of the first 6 patients, the next 3 patients will receive dose level B: 25 mg rituximab on day 1, and combination MTX (12 mg) plus rituximab (25 mg) on day 4 of each week.~Oral leucovorin rescue 24 hours after each MTX administration. Maximum injections will be 16 over 9-weeks. Subjects who experience a partial response at week 10 will be given the option for extended dosing."

Trial Locations (4)

94123

Memorial Sloan-Kettering Cancer Center, New York

94143

University of California, San Francisco, San Francisco

Unknown

Massachusetts General Hospital, Boston

MD Anderson Cancer Center, Houston

All Listed Sponsors
lead

University of California, San Francisco

OTHER

NCT00221325 - A Safety Study of Rituximab Plus MTX Injected Into the Cerebrospinal Fluid in the Treatment of Brain Lymphoma | Biotech Hunter | Biotech Hunter