Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00503594
• Date of registration: 18/07/2007
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine CNSLymphoma
• Scientific title: Multicenter Randomized Phase II Study of Methotrexate (MTX) and Temozolomide Versus MTX, Procarbazine, Vincristine and Cytarabine for Primary CNS Lymphoma (PCNSL) in the Elderly
• Date of first enrolment: July 2007
• Target sample size: 92
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00503594
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Antonio OMURO, MD,
• Affiliation: Assistance Publique - Hôpitaux de Paris

• Name: Antonio OMURO, MD,PhD

• Name: Antonio OMURO, MD,PhD

Key inclusion & exclusion 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



Age minimum: 60 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lymphoma

Intervention(s)

Drug: Methotrexate , procarbazine ,vincristine ,cytarabine

Drug: Methotrexate and temozolomide

Primary Outcome(s)

Progression-free survival [Time Frame: at one year]

Secondary Outcome(s)

Response rates [Time Frame: at end of treatment]

Overall survival:median and overall survival [Time Frame: at one and two years]

Late toxicity [Time Frame: 2 to 5 years after treatment]

Toxicity [Time Frame: during treatment]

Secondary ID(s)

P060239

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS