Phase II Study Evaluating the Combination Pegylated Liposomal Doxorubicin and Dexamethasone for the Treatment of Immunocompetent Patients With Cerebral Lymphoma Relapsed or Refractory to First-line Chemotherapy Containing High Dose Methotrexate (MTXHD) and / or High-dose Cytarabine.
Inclusion Criteria:
- Patient with cerebral lymphoma B cell refractory or relapsed within 12 months after
first-line chemotherapy with high-dose methotrexate (1.5 g / m²) and high dose
cytarabine (2g / m²) and / or radiotherapy or autologous, or patient with an
indication against these treatments.
Refractory disease is defined by the absence of objective response to treatment or relapse
within 3 months of it. A relapse is defined as disease progression after obtaining a
complete or partial response.
- Age greater than or equal to 18 years
- Performance Index less than 4
- Illness measured by CT or MRI
- Hematologic adequate: neutrophils> 1.5 x 106 / L, platelets> 100x106 / L
- Adequate hepatic function: ALT / AST and bilirubin less than the upper limit of the
normal laboratory
- Adequate renal function: creatinine clearance greater than 60 ml / min
- adequate cardiac function measured by ejection fraction of the left ventricle> 50% by
echocardiography
- Informed consent signed
- Negative pregnancy test for women of childbearing age
- Able to understand the arrangements for monitoring the study and to comply
- Corticosteroids are only accepted during the first cycle
Exclusion Criteria:
- Patients with immunosuppression from any cause (HIV, history of transplantation,
immunosuppressive treatments ...)
- Prior treatment MYOCET ® or other anthracycline
- Active infection
- Surgery large (more than 3 days hospitalization) within 28 days before enrollment in
the study, except for a diagnostic neurosurgical
- Hypersensitivity to any component of the treatment
- Contraindications to the administration of MYOCET ® and / or dexamethasone
Participation in a clinical trial within 4 weeks prior to study entry