Methotrexate, Glucarpidase, and Leucovorin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as methotrexate and leucovorin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Glucarpidase may help return the level of methotrexate in the blood to a safe range. Giving high-dose methotrexate together with glucarpidase and leucovorin may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of methotrexate when given together with glucarpidase and leucovorin in treating patients with newly diagnosed primary central nervous system lymphoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Collaborator: Cancer Research UK
• Treatments: Calcium; Leucovorin; Levoleucovorin; Methotrexate

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed newly diagnosed primary CNS lymphoma (PCNSL)

• Previously untreated disease

• Diffuse large B-cell lymphoma histology

• Must be clinically eligible to receive standard 3 g/m² methotrexate if outside trial

• No clinically significant effusions or edema

PATIENT CHARACTERISTICS:

Inclusion criteria:

• ECOG performance status 0-3

• Neutrophils ≥ 1 x 10^9/L

• Platelet count ≥ 100 x 10^9/L

• Bilirubin < 1.5 times upper limit of normal

• Glomerular filtration rate (initially measured by EDTA/isotope method) ≥ 50 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after completion of study therapy

Exclusion criteria:

• HIV positivity

• Dementia or neurological dysfunction not considered to be due to the PCNSL

• Other serious or uncontrolled medical conditions

• Prior malignancy, except adequately treated nonmelanoma skin cancer or carcinoma in situ

PRIOR CONCURRENT THERAPY:

• No prior cytotoxic chemotherapy

• No concurrent prophylactic antibiotics

• No concurrent co-trimoxazole