Phase I Study of Mitoxantrone Hydrochloride Liposome Injection
Conditions
Malignant Lymphoma
Conditions: official terms
Lymphoma
Conditions: Keywords
safety;malignant lymphoma;
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Mitoxantrone Hydrochloride Liposome
Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to determine the maximum tolerated dose,the safety and effectiveness of Mitoxantrone Hydrochloride Liposome Injection.
Detailed Description
The trial of the dose escalation method is from 18mg/m2 until the maximum tolerated dose and every 3 patient is a dose group.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Cancer Hospital ,Chinese Academy of Mddical Sciences
Beijing, China
Status: Recruiting
Contact: Yuankai Shi, Ph.D - 010-87788701
Start Date
May 2013
Completion Date
October 2015
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Source
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page