Randomized Phase II Trial on Primary Chemotherapy With High-dose Methotrexate, Alone or Associated With High-dose Cytarabine, Followed by Response- and Age-tailored Radiotherapy for Immunocompetent Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

International Extranodal Lymphoma Study Group (IELSG)1 site in 1 country79 target enrollmentJuly 2003

ConditionsLymphoma, B Cell

Interventionshigh dose methotrexate radiotherapy high dose cytarabine

Drugshigh dose methotrexate high dose cytarabine

Overview

Phase: Phase 2
Intervention: high dose methotrexate
Conditions: Lymphoma, B Cell
Sponsor: International Extranodal Lymphoma Study Group (IELSG)
Enrollment: 79
Locations: 1
Primary Endpoint: The main endpoint is the complete remission (CR) rate after chemotherapy
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 patients with primary central nervous system lymphoma

Registry

clinicaltrials.gov

Start Date

July 2003

End Date

December 2007

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

International Extranodal Lymphoma Study Group (IELSG)

Eligibility Criteria

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).