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.
- Conditions
- Cerebral Lymphoma B Cell Refractory
- Interventions
- Drug: infusion of MYOCET
- Registration Number
- NCT01848652
- Lead Sponsor
- University Hospital, Brest
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MYOCET infusion of MYOCET -
- Primary Outcome Measures
Name Time Method Answer at treatment after 2 cycles of treatment (84 days) 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 ®).
- Secondary Outcome Measures
Name Time Method Tolerance at treatment after each cycle and until the end of follow 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.
Trial Locations
- Locations (3)
Hôpital Pitié Salpêtrière
🇫🇷Paris, France
CHRU de Brest
🇫🇷Brest, France
CHU de Rennes Hôpital Pontchaillou
🇫🇷Rennes, France