Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine
Conditions
Lymphoma
Conditions: official terms
Lymphoma
Conditions: Keywords
Primary central nervous system lymphoma, Brain lymphoma, Elderly, Chemotherapy, Methotrexate, Temozolomide, Procarbazine, Vincristine, Cytarabine
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Methotrexate and temozolomide Type: Drug
Name: Methotrexate , procarbazine ,vincristine ,cytarabine Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 60 Years
Gender: Both
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
Location
Groupe hospitalier la Pitié Salpétrière
Paris, France
Status: Recruiting
Contact: Antonio OMURO, MD,PhD - + 33(0) 1 42 16 41 60 - antonio.omuro@psl.aphp.fr
Start Date
July 2007
Completion Date
July 2012
Sponsors
Assistance Publique - Hôpitaux de Paris
Source
Assistance Publique - Hôpitaux de Paris
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page