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.

University Hospital, Brest3 sites in 1 country5 target enrollmentOctober 2013

ConditionsCerebral Lymphoma B Cell Refractory

Interventionsinfusion of MYOCET

Drugsinfusion of MYOCET

Overview

Phase: Phase 2
Intervention: infusion of MYOCET
Conditions: Cerebral Lymphoma B Cell Refractory
Sponsor: University Hospital, Brest
Enrollment: 5
Locations: 3
Primary Endpoint: Answer at treatment
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

May 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Brest

Responsible Party

Sponsor

Eligibility 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

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

Arms & Interventions

MYOCET

Intervention: infusion of MYOCET

Outcomes

Primary Outcomes

Answer at treatment

Time Frame: 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 ®).