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

Stopped early · Phase 2

Conditions studied: Lymphoma

In brief

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.

Key facts

Study ID

NCT00335140

Run by

Eastern Cooperative Oncology Group

People needed

26

Starts

2007-08-23

Expected to finish

2015-07-01

Last updated by the study team

2023-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Stanford Cancer Center — Stanford, California, United States

Full record on ClinicalTrials.gov

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