Lymphoma | Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine
Lymphoma research study
What is the primary objective of this study?
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
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Methotrexate and temozolomideMethotrexate and temozolomide
Drug:Methotrexate , procarbazine ,vincristine ,cytarabineMethotrexate , procarbazine ,vincristine ,cytarabine
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
1Comparative 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.
bras conventionalbras conventional
Start Date: July 2007
Completed Date: July 2012
Phase: Phase 2
Primary Outcome: Progression-free survival
Secondary Outcome: Overall survival:median and overall survival
Study sponsors, principal investigator, and references
Principal Investigator: Antonio OMURO, MD,
Lead Sponsor: Assistance Publique - Hôpitaux de Paris
Collaborator: French Innovative Leukemia Organisation
Omuro AM, Abrey LE. Chemotherapy for primary central nervous system lymphoma. Neurosurg Focus. 2006 Nov 15;21(5):E12. Review.