| July 18, 2007 |
| July 20, 2007 |
| July 2007 |
| |
| Progression-free survival [ Time Frame: at one year ] |
| Same as current |
| Complete list of historical versions of study NCT00503594 on ClinicalTrials.gov Archive Site |
- Overall survival:median and overall survival [ Time Frame: at one and two years ]
- Response rates [ Time Frame: at end of treatment ]
- Toxicity [ Time Frame: during treatment ]
- Late toxicity [ Time Frame: 2 to 5 years after treatment ]
|
| Same as current |
| |
| Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine |
| 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 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
|
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. |
| Phase II |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Lymphoma |
- Drug: Methotrexate and temozolomide
- Drug: Methotrexate , procarbazine ,vincristine ,cytarabine
|
| Active Comparator: Comparative evaluation of the efficiency of a new protocol of the primitive lymphome of the central nervous system ( LPSNC) to the old subject, associating Méthotrexate and Témozolomide with regard to a standard protocol associating Méthotrexate, Procarbazine, Vincristine and Cytarabine. |
| Omuro AM, Abrey LE. Chemotherapy for primary central nervous system lymphoma. Neurosurg Focus. 2006 Nov 15;21(5):E12. Review. |
| |
| Recruiting |
| 92 |
| July 2012 |
|
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
|
| Both |
| 60 Years and older |
| No |
|
|
| France |
| |
| NCT00503594 |
|
| P060239, AOM06175 |
| Assistance Publique - Hôpitaux de Paris |
- ANOCEF – Association de Neuro-Oncologues d’Expression Francaise
- Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
|
| Principal Investigator: |
Antonio OMURO, MD, |
Assistance Publique - Hôpitaux de Paris |
|
|
| Assistance Publique - Hôpitaux de Paris |
| July 2007 |
