Phase II Study of High Dose Systemic Methotrexate in Patients with Primary Central Nervous System Lymphoma
High-Dose Methotrexate in Treating Patients With Primary Central Nervous System Lymphoma
Basic Trial Information
|Phase II||Treatment||Completed||18 and over||NCI||NABTT-9607|
I. Determine the response rate of primary central nervous system lymphoma to induction therapy with systemic methotrexate. II. Assess the time to progression, site of relapse, and toxicity of systemic methotrexate in patients with primary central nervous system lymphoma. III. Assess the survival time and quality of life of this patient population.
Histologically proven primary central nervous system lymphoma of the following types: Non-Hodgkin's B-cell lymphoma by brain biopsy or resection Intracranial disease by positive cytology or immunohistochemical diagnosis of monoclonality Vitreal lymphoma with measurable intracranial tumor Disease must be confined to eye, brain, leptomeninges, or CSF
Biologic therapy: No prior transplant Chemotherapy: No prior chemotherapy for primary central nervous system lymphoma No concurrent chemotherapy Endocrine therapy: No concurrent immunosuppressive treatment Radiotherapy: No prior cranial radiotherapy Surgery: Prior biopsy or resection allowed Other: At least 1 week since salicylates, non-steroidal anti-inflammatory drugs, or sulfonamides
Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT/SGPT no greater than 4 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min Other: Not allergic to methotrexate Not HIV positive No preexisting immunosuppression Not pregnant or nursing No prior malignancy within 5 years except basal cell skin cancer or carcinoma in situ of the cervix
A total of 25 patients will be accrued for the study.
Patients receive induction chemotherapy with high-dose methotrexate intravenously every 14 days for 4 to 8 courses of treatment. Patients with complete response receive consolidation therapy with methotrexate for 2 more courses, followed by maintenance therapy with monthly methotrexate IV for 11 months. Patients not achieving a complete response after 8 courses of induction therapy are removed from study. Quality of life is assessed before treatment, then at 3 and 12 months, and annually thereafter. Patients are followed for survival every 2 months or until death.
Gerstner ER, Carson KA, Grossman SA, et al.: Long-term outcome in PCNSL patients treated with high-dose methotrexate and deferred radiation. Neurology 70 (5): 401-2, 2008.[PUBMED Abstract]
Gerber DE, Grossman SA, Batchelor T, et al.: Calculated versus measured creatinine clearance for dosing methotrexate in the treatment of primary central nervous system lymphoma. Cancer Chemother Pharmacol 59 (6): 817-23, 2007.[PUBMED Abstract]
Batchelor T, Carson K, O'Neill A, et al.: Treatment of primary CNS lymphoma with methotrexate and deferred radiotherapy: a report of NABTT 96-07. J Clin Oncol 21 (6): 1044-9, 2003.[PUBMED Abstract]
Batchelor TT, Hochberg F, O'Neill A, et al.: The treatment of primary central nervous system lymphoma (PCNSL) with methotrexate and deferred radiotherapy: NABTT 96-07. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A616, 2000.
Trial Contact Information
Trial Lead Organizations
New Approaches to Brain Tumor Therapy
Ph: 617-643-1938; 877-726-5130
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.