Phase II Trial of Combined Modality Treatment in Primary Central Nervous System Lymphoma

Phase 2

Completed

• Conditions: Lymphoma, B Cell
• Interventions: Drug: high dose methotrexate; Drug: high dose cytarabine; Radiation: radiotherapy

• Registration Number: NCT00210314
• Lead Sponsor: International Extranodal Lymphoma Study Group (IELSG)

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2007-09
• Study Completion: 2007-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-27
• Last Update Posted: 2015-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

1. Histological or cytological diagnosis of non-Hodgkin's lymphoma.
2. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy.
3. Disease exclusively localized into the central nervous system, cranial nerves or eyes.
4. Untreated patients (patients treated with steroids alone are eligible).
5. At least one measurable lesion.
6. Age 18 - 75 years.
7. ECOG performance status < 3
8. HBsAg-negative and Ab anti-HCV-negative serologic status.
9. No known HIV disease or immunodeficiency.
10. 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).
11. 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).
12. Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
13. Non-pregnant and non-lactating status for female patients. Adequate contraceptive measures during study participation for sexually active patients of childbearing potential.
14. No concurrent treatment with other experimental drugs.
15. Informed consent signed by the patient before registration

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-dose methotrexate associated with high dose cytarabine	high dose cytarabine	-
High-dose methotrexate alone	high dose methotrexate	-
High-dose methotrexate alone	radiotherapy	-
High-dose methotrexate associated with high dose cytarabine	high dose methotrexate	-
High-dose methotrexate associated with high dose cytarabine	radiotherapy	-

Primary Outcome Measures

Name	Time	Method
The main endpoint is the complete remission (CR) rate after chemotherapy

Secondary Outcome Measures

Name	Time	Method
Early and late neurotoxicity
Overall response rate
Response duration (time to relapse or progression) for responder patients
Overall survival
Event-free survival
Meningeal relapse rate

Trial Locations

Locations (1)

Oncology Institute of Southern Switzerland (IOSI); 🇨🇭 Bellinzona, Switzerland