Clinical trial NCT00210314: Phase II Trial of Combined Modality Treatment in Primary Central Nervous System Lymphoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, B Cell
Lead sponsor: International Extranodal Lymphoma Study Group (IELSG)
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: The main endpoint is the complete remission (CR) rate after chemotherapy
Secondary outcomes:
measure: Overall response rate
measure: Response duration (time to relapse or progression) for responder patients
measure: Overall survival
measure: Event-free survival
measure: Meningeal relapse rate
measure: Early and late neurotoxicity
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Oncology Institute of Southern Switzerland (IOSI)
Study officials:
affiliation: Radiochemotherapy. San Raffaele Hospital. Milan
name: Andres JM Ferreri, MD
role: STUDY_CHAIR
affiliation: Radiochemotherapy. San Raffaele Hospital. Milan
name: Michele Reni, MD
role: STUDY_CHAIR
affiliation: International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland (IOSI)
name: Emanuele Zucca, MD
role: STUDY_CHAIR
References:
citation: Ferreri AJ, Reni M, Foppoli M, Martelli M, Pangalis GA, Frezzato M, Cabras MG, Fabbri A, Corazzelli G, Ilariucci F, Rossi G, Soffietti R, Stelitano C, Vallisa D, Zaja F, Zoppegno L, Aondio GM, Avvisati G, Balzarotti M, Brandes AA, Fajardo J, Gomez H, Guarini A, Pinotti G, Rigacci L, Uhlmann C, Picozzi P, Vezzulli P, Ponzoni M, Zucca E, Caligaris-Cappio F, Cavalli F; International Extranodal Lymphoma Study Group (IELSG). High-dose cytarabine plus high-dose methotrexate versus high-dose methotrexate alone in patients with primary CNS lymphoma: a randomised phase 2 trial. Lancet. 2009 Oct 31;374(9700):1512-20. doi: 10.1016/S0140-6736(09)61416-1. Epub 2009 Sep 18.