Status:
COMPLETED
Phase II Trial of Combined Modality Treatment in Primary Central Nervous System Lymphoma
Lead Sponsor:
International Extranodal Lymphoma Study Group (IELSG)
Conditions:
Lymphoma, B Cell
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Aim of the study is to establish in a prospective, randomized clinical trial the activity of primary chemotherapy containing high dose-methotrexate, alone or combined with high dose cytarabine, in pat...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histological or cytological diagnosis of non-Hodgkin's lymphoma.
- Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy.
- Disease exclusively localized into the central nervous system, cranial nerves or eyes.
- Untreated patients (patients treated with steroids alone are eligible).
- At least one measurable lesion.
- Age 18 - 75 years.
- ECOG performance status \< 3
- HBsAg-negative and Ab anti-HCV-negative serologic status.
- No known HIV disease or immunodeficiency.
- Adequate bone marrow (PLT \> 100000 mm3, Hb ≥ 9 g/dl, ANC ≥ 2.000 mm3), renal (creatinine clearance ≥ 60 mL/min), cardiac (VEF ≥ 50%), and hepatic function (total serum bilirubin \< 3 mg/dL, AST/ALT and gGT \< 2 per upper normal limit value).
- No previous or concurrent malignancies with the exception of surgically cured cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer and of other cancers without evidence of disease since at least 5 years (patients with a previous lymphoma diagnosis will be excluded).
- Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Non-pregnant and non-lactating status for female patients. Adequate contraceptive measures during study participation for sexually active patients of childbearing potential.
- No concurrent treatment with other experimental drugs.
- Informed consent signed by the patient before registration
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00210314
Start Date
July 1 2003
End Date
December 1 2007
Last Update
March 30 2015
Active Locations (1)
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1
Oncology Institute of Southern Switzerland (IOSI)
Bellinzona, Switzerland, 6500