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

International Extranodal Lymphoma Study Group (IELSG)

Status and phase: Completed; Phase 2

Conditions: Lymphoma, B Cell

Treatments: Radiation: radiotherapy; Drug: high dose methotrexate; Drug: high dose cytarabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00210314

IELSG20

Details and patient eligibility

About

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

Enrollment: 79 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

79 participants in 2 patient groups

High-dose methotrexate alone

Active Comparator group

Treatment:

Radiation: radiotherapy

Drug: high dose methotrexate

High-dose methotrexate associated with high dose cytarabine

Experimental group

Treatment:

Radiation: radiotherapy

Drug: high dose methotrexate

Drug: high dose cytarabine