Phase I Study of Mitoxantrone Hydrochloride Liposome Injection

Study Overview
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Brief Summary
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The purpose of this study is to determine the maximum tolerated dose,the safety and effectiveness of Mitoxantrone Hydrochloride Liposome Injection.

Detailed Description
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The trial of the dose escalation method is from 18mg/m2 until the maximum tolerated dose and every 3 patient is a dose group.

Official Title
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Phase I Dose Escalation Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Malignant Lymphoma

Conditions
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Malignant Lymphoma

Intervention / Treatment
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* Drug: Mitoxantrone Hydrochloride Liposome


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must compliance with the requirements and restrictions listed in the consent form Patients with Pathology and / or cytologically proven malignant lymphoma Patients must be 18-70 years old ,both male and female Failure of standard chemotherapy Patients have no better choice and may be benefit from the use of anthracyclines Patients with Eastern Cooperative Oncology Group (ECOG)Performance Status of 0-2 Objective tumor from the last chemotherapy, biological therapy or other experimental interval treatment least 4 weeks Expected survival time ≥ 3 months Patients agreed to take effective contraceptive measures during the trial Blood routine, liver and kidney function, cardiac function examination in accordance with the following requirements. Exclusion Criteria: Pregnancy and breast-feeding women Multiple sclerosis Patients that have histories of ischemic heart disease and heart congestive,arrhythmia that need to be a treatment and significant valvular disease Patients with heart disease induced by anthracycline Patients requiring other antineoplastic treatment Patients with temperature above 38 degrees or active infection that may effects in clinical tests Patients are allergic to anthracycline and liposomal drugs Patients are allergic to eggs,egg products,soybean and soybean products Patients with uncontrolled primary or metastatic brain tumorsMultiple sclerosis Patients that have histories of ischemic heart disease and heart congestive,arrhythmia that need to be a treatment and significant valvular disease Patients with heart disease induced by anthracycline Patients requiring other antineoplastic treatment Patients with temperature above 38 degrees or active infection that may effects in clinical tests Patients are allergic to anthracycline and liposomal drugs Patients are allergic to eggs,egg products,soybean and soybean products Patients with uncontrolled primary or metastatic brain tumors Total amount of Doxorubicin(or Pirarubicin)≥360mg/m2,Epirubicin ≥600mg/m2

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mitoxantrone Hydrochloride Liposome<br> | Drug: Mitoxantrone Hydrochloride Liposome<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose (MTD) of Mitoxantrone Hydrochloride Liposome Injection |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety;malignant lymphoma;