Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as methotrexate and thiotepa, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining methotrexate with thiotepa in treating patients who have newly-diagnosed primary CNS lymphoma.

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

Details

• Lead Sponsor: New Approaches to Brain Tumor Therapy Consortium
• Collaborator: National Cancer Institute (NCI)
• Treatments: Calcium; Leucovorin; Levoleucovorin; Methotrexate; Thiotepa

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary CNS lymphoma

• Confirmed by 1 of the following:

• Brain biopsy or resection

• CSF cytology

• Positive cytology or immunohistochemical diagnosis of monoclonality and measurable intracranial tumor

• Vitreal biopsy

• Measurable and contrast-enhancing disease on the postoperative, pretreatment MRI or CT scan

• No radiographic evidence of ascites or pleural effusions

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 2.0 mg/dL

• SGOT no greater than 4 times upper limit of normal

Renal

• Creatinine no greater than 2 mg/dL

• Creatinine clearance at least 50 mL/min

Other

• Mini mental score of at least 15

• HIV negative

• Able to achieve hydration

• No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ

• No allergy to methotrexate

• No serious infection

• No medical illness that would preclude study participation

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior immunotherapy or biologic therapy for this disease

Chemotherapy

• No prior chemotherapy for this disease

• No other concurrent chemotherapeutic agents

Endocrine therapy

• No prior hormonal therapy for this disease

• Prior glucocorticoid therapy allowed

Radiotherapy

• No prior radiotherapy for this disease

• No prior cranial irradiation

Surgery

• See Disease Characteristics

Other

• At least 1 week since prior salicylates, non-steroidal anti-inflammatory drugs, probenecid, folic acid, or sulfonamide medications

• No other concurrent investigational agents