CNSLymphoma: Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Unknown status

CT.gov ID

NCT00503594

Collaborator

French Innovative Leukemia Organisation (Other)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: Methotrexate and temozolomide Drug: Methotrexate , procarbazine ,vincristine ,cytarabine	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Jul 1, 2010

Anticipated Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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.	Drug: Methotrexate and temozolomide Methotrexate and temozolomide
Active Comparator: bras conventional bras conventional	Drug: Methotrexate , procarbazine ,vincristine ,cytarabine Methotrexate , procarbazine ,vincristine ,cytarabine

Arm

Intervention/Treatment

Experimental: 1

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.

Drug: Methotrexate and temozolomide

Methotrexate and temozolomide

Active Comparator: bras conventional

bras conventional

Drug: Methotrexate , procarbazine ,vincristine ,cytarabine

Methotrexate , procarbazine ,vincristine ,cytarabine

Outcome Measures

Primary Outcome Measures

Progression-free survival [at one year]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts 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