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. (MYLY)

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.

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.

Study Overview

• Status: Terminated
• Conditions: Cerebral Lymphoma B Cell Refractory
• Intervention / Treatment: Drug: infusion of MYOCET

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU de Brest
  • Paris, France, 75651
    • Hopital Pitie Salpetriere
  • Rennes, France, 35033
    • CHU de Rennes Hôpital Pontchaillou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MYOCET	Drug: infusion of MYOCET

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Collaborators: Teva Pharmaceuticals USA
• Investigators: Principal Investigator: Adrian TEMPESCUL, Dr, University Hospital of Brest

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: May 3, 2013
• First Submitted That Met QC Criteria: May 3, 2013
• First Posted (Estimate): May 7, 2013

Study Record Updates

• Last Update Posted (Estimate): July 14, 2015
• Last Update Submitted That Met QC Criteria: July 13, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: safety; efficacy; cerebral lymphoma B cell refractory; Myocet
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Doxorubicin
• Other Study ID Numbers: RB 12.032 - MYLY