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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2007-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Lymphoma, B Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High-dose methotrexate alone

Group Type ACTIVE_COMPARATOR

high dose methotrexate

Intervention Type DRUG

radiotherapy

Intervention Type RADIATION

High-dose methotrexate associated with high dose cytarabine

Group Type EXPERIMENTAL

high dose methotrexate

Intervention Type DRUG

high dose cytarabine

Intervention Type DRUG

radiotherapy

Intervention Type RADIATION

Interventions

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high dose methotrexate

Intervention Type DRUG

high dose cytarabine

Intervention Type DRUG

radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No