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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00503594

Acronym

CNSLymphoma

Enrollment

Registered

2007-07-19

Start date

2007-07-31

Completion date

2012-07-31

Last updated

2012-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

Primary central nervous system lymphoma, Brain lymphoma, Elderly, Chemotherapy, Methotrexate, Temozolomide, Procarbazine, Vincristine, Cytarabine

Brief 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

Detailed description

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.

Interventions

DRUGMethotrexate and temozolomide

Methotrexate and temozolomide

DRUGMethotrexate , procarbazine ,vincristine ,cytarabine

Methotrexate , procarbazine ,vincristine ,cytarabine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progression-free survival	at one year

Secondary

Measure	Time frame
Overall survival:median and overall survival	at one and two years
Response rates	at end of treatment
Toxicity	during treatment
Late toxicity	2 to 5 years after treatment

Countries

France

Contacts

Primary ContactAntonio OMURO, MD,PhD

antonio.omuro@psl.aphp.fr+ 33(0) 1 42 16 41 60

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026