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Spots Global Cancer Trial Database for Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma

Official Title: Phase II Study of Rituximab Given in Conjunction With Standard Chemotherapy in Primary Central Nervous System (CNS) Lymphoma

Study ID: NCT00335140

Conditions

Lymphoma

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Cancer Center of Kansas, PA - Chanute, Chanute, Kansas, United States

Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States

Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas, United States

Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States

Cancer Center of Kansas-Independence, Independence, Kansas, United States

Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, United States

Lawrence Memorial Hospital, Lawrence, Kansas, United States

Southwest Medical Center, Liberal, Kansas, United States

Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States

Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, United States

Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, United States

Cancer Center of Kansas, PA - Salina, Salina, Kansas, United States

Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, United States

Associates in Womens Health, PA - North Review, Wichita, Kansas, United States

Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas, United States

Cancer Center of Kansas, PA - Wichita, Wichita, Kansas, United States

CCOP - Wichita, Wichita, Kansas, United States

Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States

Wesley Medical Center, Wichita, Kansas, United States

Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

Borgess Medical Center, Kalamazoo, Michigan, United States

West Michigan Cancer Center, Kalamazoo, Michigan, United States

Bronson Methodist Hospital, Kalamazoo, Michigan, United States

Fairview Ridges Hospital, Burnsville, Minnesota, United States

Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States

Fairview Southdale Hospital, Edina, Minnesota, United States

Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States

Hutchinson Area Health Care, Hutchinson, Minnesota, United States

HealthEast Cancer Care at St. John's Hospital, Maplewood, Minnesota, United States

Minnesota Oncology Hematology, PA - Maplewood, Maplewood, Minnesota, United States

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota, United States

Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota, United States

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States

Park Nicollet Cancer Center, Saint Louis Park, Minnesota, United States

Regions Hospital Cancer Care Center, Saint Paul, Minnesota, United States

United Hospital, Saint Paul, Minnesota, United States

St. Francis Cancer Center at St. Francis Medical Center, Shakopee, Minnesota, United States

Ridgeview Medical Center, Waconia, Minnesota, United States

Minnesota Oncology Hematology, PA - Woodbury, Woodbury, Minnesota, United States

Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio, United States

Barberton Citizens Hospital, Barberton, Ohio, United States

Aultman Cancer Center at Aultman Hospital, Canton, Ohio, United States

MetroHealth Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, United States

Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest, Allentown, Pennsylvania, United States

Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania, United States

Geisinger Hazleton Cancer Center, Hazleton, Pennsylvania, United States

Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States

Geisinger Medical Group - Scenery Park, State College, Pennsylvania, United States

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States

Medical X-Ray Center, PC, Sioux Falls, South Dakota, United States

Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota, United States

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

West Virginia University Health Sciences Center - Charleston, Charleston, West Virginia, United States

Gundersen Lutheran Center for Cancer and Blood, La Crosse, Wisconsin, United States

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States

Contact Details

Name: Lode J. Swinnen, MD

Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Role: STUDY_CHAIR

Name: Deborah T. Blumenthal, MD

Affiliation: University of Utah

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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