Multicenter Randomized Phase II Study of Methotrexate (MTX) and Temozolomide Versus MTX, Procarbazine, Vincristine and Cytarabine for Primary CNS Lymphoma (PCNSL) in the Elderly
60 Years
N/A
Both
Lymphoma
Trial Information
Multicenter Randomized Phase II Study of Methotrexate (MTX) and Temozolomide Versus MTX, Procarbazine, Vincristine and Cytarabine for Primary CNS Lymphoma (PCNSL) in the Elderly
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Time Frame:
at one year
Safety Issue:
Yes
Principal Investigator
Antonio OMURO, MD,
Investigator Role:
Principal Investigator
Investigator Affiliation:
Assistance Publique - Hôpitaux de Paris
Authority:
France: Ministry of Health
Study ID:
P060239
NCT ID:
NCT00503594
Start Date:
July 2007
Completion Date:
July 2012
Related Keywords:
- Lymphoma
- Primary central nervous system lymphoma
- Brain lymphoma
- Elderly
- Chemotherapy
- Methotrexate
- Temozolomide
- Procarbazine
- Vincristine
- Cytarabine
- Lymphoma
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