Non Hodgkin Lymphoma Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria:

Histologically confirmed non-Hodgkin's lymphoma by brain biopsy

Patients with inconclusive biopsy or patients who are not candidates for biopsy must have typical CT scan or MRI of the brain AND meet ≥ 1 of the following criteria:

Positive cerebrospinal fluid cytology for lymphoma OR a monoclonal lymphoid population as defined by cell surface markers or immunoglobulin gene rearrangement studies
Biopsy-proven involvement of the vitreous or uvea if cells are apparent in the posterior chamber or vitreous by ophthalmological examination

Bideminsionally measurable disease, defined as contrast-enhancing tumor ≥ 1 cm by pretreatment MRI/CT scan

Meningeal or vitreous involvement constitutes evaluable but not measurable disease
If an excisional, rather than a needle biopsy was done, measurable disease must be present on a postoperative scan (not a PET-CT scan)
ECOG performance status 0-3
Absolute granulocyte count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Bilirubin ≤ upper limit of normal (ULN)
SGOT ≤ 2.0 times ULN
Creatinine clearance ≥ 50 mL/min
Negative pregnancy test
Fertile patients must use effective contraception

Exclusion criteria:

Pregnant or nursing
HIV-1 positivity
Other malignancy within the past 5 years except basal cell skin cancer or any carcinoma in situ
Pre-existing immunodeficiency
Hepatitis B surface antigen positivity
Systemic lymphoma (as determined by pre-registration CT scans and physical examination)
Prior chemotherapy or radiotherapy for primary central nervous system lymphoma
Prior organ or bone marrow transplantation

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

26

Study ID:

NCT00335140

Recruitment Status:

Terminated

Sponsor:

Eastern Cooperative Oncology Group

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There are 59 Locations for this study

See Locations Near You

Stanford Cancer Center
Stanford California, 94305, United States
University of Florida Shands Cancer Center
Gainesville Florida, 32610, United States
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago Illinois, 60612, United States
Hinsdale Hematology Oncology Associates
Hinsdale Illinois, 60521, United States
McFarland Clinic, PC
Ames Iowa, 50010, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Hospital District Sixth of Harper County
Anthony Kansas, 67003, United States
Cancer Center of Kansas, PA - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence Kansas, 67301, United States
Cancer Center of Kansas, PA - Kingman
Kingman Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence Kansas, 66044, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina Kansas, 67042, United States
Cancer Center of Kansas, PA - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Wesley Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield Kansas, 67156, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
Borgess Medical Center
Kalamazoo Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson Minnesota, 55350, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood Minnesota, 55109, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis Minnesota, 55415, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale Minnesota, 55422, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park Minnesota, 55416, United States
Regions Hospital Cancer Care Center
Saint Paul Minnesota, 55101, United States
United Hospital
Saint Paul Minnesota, 55102, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee Minnesota, 55379, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury Minnesota, 55125, United States
Summa Center for Cancer Care at Akron City Hospital
Akron Ohio, 44309, United States
Barberton Citizens Hospital
Barberton Ohio, 44203, United States
Aultman Cancer Center at Aultman Hospital
Canton Ohio, 44710, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland Ohio, 44109, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown Pennsylvania, 18105, United States
Geisinger Cancer Institute at Geisinger Health
Danville Pennsylvania, 17822, United States
Geisinger Hazleton Cancer Center
Hazleton Pennsylvania, 18201, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia Pennsylvania, 19111, United States
Geisinger Medical Group - Scenery Park
State College Pennsylvania, 16801, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre Pennsylvania, 18711, United States
Medical X-Ray Center, PC
Sioux Falls South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls South Dakota, 57117, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
West Virginia University Health Sciences Center - Charleston
Charleston West Virginia, 25304, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse Wisconsin, 54601, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison Wisconsin, 53792, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

26

Study ID:

NCT00335140

Recruitment Status:

Terminated

Sponsor:


Eastern Cooperative Oncology Group

How clear is this clinincal trial information?

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