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

Sponsor

International Extranodal Lymphoma Study Group (IELSG) (Other)

Overall Status

Completed

CT.gov ID

NCT00210314

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, B Cell	Drug: high dose methotrexate Drug: high dose cytarabine Radiation: radiotherapy	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

79 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2003

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: High-dose methotrexate alone	Drug: high dose methotrexate Radiation: radiotherapy
Experimental: High-dose methotrexate associated with high dose cytarabine	Drug: high dose methotrexate Drug: high dose cytarabine Radiation: radiotherapy

Arm

Intervention/Treatment

Active Comparator: High-dose methotrexate alone

Drug: high dose methotrexate

Radiation: radiotherapy

Experimental: High-dose methotrexate associated with high dose cytarabine

Drug: high dose methotrexate

Drug: high dose cytarabine

Radiation: radiotherapy

Outcome Measures

Primary Outcome Measures

The main endpoint is the complete remission (CR) rate after chemotherapy []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oncology Institute of Southern Switzerland (IOSI)	Bellinzona		Switzerland	6500

Sponsors and Collaborators

International Extranodal Lymphoma Study Group (IELSG)

Investigators

Study Chair: Andres JM Ferreri, MD, Radiochemotherapy. San Raffaele Hospital. Milan
Study Chair: Michele Reni, MD, Radiochemotherapy. San Raffaele Hospital. Milan
Study Chair: Emanuele Zucca, MD, International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland (IOSI)