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) a

• Status: Terminated
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Brest
• Collaborators: TEVA; Teva Pharmaceuticals USA
• Treatments: BB 1101; Cytarabine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin; Methotrexate

Criteria

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