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

• Status: Terminated
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: BB 1101; Cytarabine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Leucovorin; Levoleucovorin; Methotrexate; Procarbazine; Rituximab; Vincristine

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