Status:
TERMINATED
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.
Lead Sponsor:
University Hospital, Brest
Collaborating Sponsors:
Teva Pharmaceuticals USA
Conditions:
Cerebral Lymphoma B Cell Refractory
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 dexametha...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01848652
Start Date
October 1 2013
End Date
May 1 2015
Last Update
July 14 2015
Active Locations (3)
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1
CHRU de Brest
Brest, France, 29609
2
Hôpital Pitié Salpêtrière
Paris, France, 75651
3
CHU de Rennes Hôpital Pontchaillou
Rennes, France, 35033