Phase II Study of Rituximab Given in Conjunction With Standard Chemotherapy in 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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Complete response rate at the end of study treatment
No
Lode J. Swinnen, MD
Study Chair
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
CDR0000475776
NCT00335140
December 2006
Name | Location |
---|---|
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
Aultman Cancer Center at Aultman Hospital | Canton, Ohio 44710-1799 |
MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44109 |
Geisinger Medical Group - Scenery Park | State College, Pennsylvania 16801 |
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
Wesley Medical Center | Wichita, Kansas 67214 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Southwest Medical Center | Liberal, Kansas 67901 |
Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
West Virginia University Health Sciences Center - Charleston | Charleston, West Virginia 25302 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Stanford Cancer Center | Stanford, California 94305-5824 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Hospital District Sixth of Harper County | Anthony, Kansas 67003 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Barberton Citizens Hospital | Barberton, Ohio 44203 |
Geisinger Hazleton Cancer Center | Hazleton, Pennsylvania 18201 |
John H. Stroger, Jr. Hospital of Cook County | Chicago, Illinois 60612-9985 |