Phase II Study Evaluating a Combination of Pegylated Liposomal Doxorubicin and Dexamethasone for the Treatment of Immunocompetent Patients With Cerebral Lymphoma Relapsed or Refractory to First-line Chemotherapy With High Dose Methotrexate (MTXHD) and / or High-dose Cytarabine.

Study Overview
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Brief Summary
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The protocol is to assess the overall response rate (complete response and partial response) of treatment with non-pegylated liposomal doxorubicin at a dose of 50 mg / m² in combination with dexamethasone in immunocompetent adult patients with primary brain lymphoma large B-cell refractory or relapsed after first-line treatment MTXHD and high-dose cytarabine, excluding strict eye lymphomas. This is a Phase II, open, prospective, multicenter, non-comparative with direct individual benefit.

Official Title
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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.

Conditions
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Cerebral Lymphoma B Cell Refractory

Intervention / Treatment
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* Drug: infusion of MYOCET


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MYOCET<br> | Drug: infusion of MYOCET<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Answer at treatment | Answer, whether complete or partial, according to the International Primary CNS Lymphoma Collaborative Group (IPCG) (ASH 2004) after two cycles of treatment (4 infusions MYOCET ®). | after 2 cycles of treatment (84 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance at treatment | Tolerance, assessed according to the criteria of the National Cancer Institute (NCI)-Common Toxicity Criteria (CTC) version (version 4.03) after administration of each cycle, overall survival, progression-free and disease-free event for complete responses. | after each cycle and until the end of follow | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocet, cerebral lymphoma B cell refractory, efficacy, safety