Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine

• Status: Unknown status
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: French Innovative Leukemia Organisation
• Treatments: Cytarabine; Dacarbazine; Methotrexate; Procarbazine; Temozolomide; Vincristine

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