Multicenter Randomized Phase II Study of Methotrexate (MTX) and Temozolomide Versus MTX, Procarbazine, Vincristine and Cytarabine for Primary CNS Lymphoma (PCNSL) in the Elderly
Overview
- Phase
- Phase 2
- Intervention
- Methotrexate and temozolomide
- Conditions
- Lymphoma
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Last Updated
- 13 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
1
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.
Intervention: Methotrexate and temozolomide
bras conventional
bras conventional
Intervention: Methotrexate , procarbazine ,vincristine ,cytarabine
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: at one year
Secondary Outcomes
- 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)