Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine

Study Overview
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Brief Summary
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The purpose of this study is to evaluate two types of chemotherapy for primary central nervous system lymphoma in the elderly (age older than 60) : Methotrexate, procarbazine, vincristine and cytarabine Methotrexate and temozolomide

Detailed Description
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The aim of the study is to evaluate efficacy and toxicity associated with both protocols in this population, without radiotherapy. Patients will be randomized to receive one of the two regimens in one of the participating centers. Neuropsychological evaluation will be performed in all patients. Patients will be followed with serial MRIs.

Official Title
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Multicenter Randomized Phase II Study of Methotrexate (MTX) and Temozolomide Versus MTX, Procarbazine, Vincristine and Cytarabine for Primary CNS Lymphoma (PCNSL) in the Elderly

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: Methotrexate and temozolomide
* Drug: Methotrexate , procarbazine ,vincristine ,cytarabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary central nervous system lymphoma histologically confirmed by brain biopsy, CSF cytology or vitrectomy KPS 40 or higher Absence of systemic disease as evaluated by chest-abdomen-pelvis CT scan Leucocytes>3.500/mm3, platelets>130.000/mm3, Bilirubin < 2 mg, transaminases < 2.5 N), creatinine < 150 μM/l, creatinine clearance > 40 ml/min Age ≥ 60 years Negative HIV test Signature of informed consent Exclusion Criteria: previous cranial radiotherapy prior chemotherapy for primary central nervous system lymphoma presence of another cancer (excepting basal cell carcinoma of the skin and cervical carcinoma in situ ) systemic lymphoma (outside the CNS) Isolated ocular lymphoma Immunosuppressed patients (HIV , use of immunosuppressors) Other uncontrolled or progressive disease compromising shot-term survival Severe renal or hepatic disease Patients not legally covered by the French Social Security Inability to swallow the medication

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Comparative evaluation of the efficiency of a new protocol of the primitive LYMPHOME of the central nervous system ( LPSNC) to the old subject, associating Methotrexate and Temozolomide with regard to a standard protocol associating Methotrexate, Procarbazine, Vincristine and Cytarabine. | Drug: Methotrexate and temozolomide<br>* Methotrexate and temozolomide<br>|
| Active Comparator: bras conventional<br>bras conventional | Drug: Methotrexate , procarbazine ,vincristine ,cytarabine<br>* Methotrexate , procarbazine ,vincristine ,cytarabine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | at one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival:median and overall survival |  | at one and two years | 
| Response rates |  | at end of treatment | 
| Toxicity |  | during treatment | 
| Late toxicity |  | 2 to 5 years after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary central nervous system lymphoma, Brain lymphoma, Elderly, Chemotherapy, Methotrexate, Temozolomide, Procarbazine, Vincristine, Cytarabine