Status:
TERMINATED
Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma
Lead Sponsor:
Eastern Cooperative Oncology Group
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 t...
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 surviv...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 23 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00335140
Start Date
August 23 2007
End Date
July 1 2015
Last Update
July 3 2023
Active Locations (68)
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1
Stanford Cancer Center
Stanford, California, United States, 94305-5824
2
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
3
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
4
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612-3785