Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine

Phase 2

• Conditions: Lymphoma
• Interventions: Drug: Methotrexate and temozolomide; Drug: Methotrexate , procarbazine ,vincristine ,cytarabine

• Registration Number: NCT00503594
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Status Verified: 2007-07
• Study Start: 2007-07
• Study First Submitted: 2007-07-18
• Study First Submitted QC: 2007-07-18
• Study First Posted: 2007-07-19
• Primary Completion: 2010-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-07-27
• Last Update Posted: 2012-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 92

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Methotrexate and temozolomide	Comparative 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 conventional	Methotrexate , procarbazine ,vincristine ,cytarabine	bras conventional

Primary Outcome Measures

Name	Time	Method
Progression-free survival	at one year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Groupe hospitalier la Pitié Salpétrière; 🇫🇷 Paris, France