Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases

• Status: Unknown status
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to evaluate the clinical efficacy and safety of continuous Endostar infusion combined with radiotherapy for treatment of brain metastases.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Collaborator: The First People's Hospital of Lianyungang
• Treatments: Endostar protein

Criteria

Inclusion Criteria:

• Histologically confirmed malignancy with presence of intraparenchymal brain metastases

• Karnofsky performance status ≥ 40

• Measurable disease according to RECIST criteria

• Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L

• Renal function: Cr ≤ 2.0×ULN

• Hepatic function: BIL ≤ 2.0×ULN, ALT/AST ≤ 5.0×ULN

• Adequate cardiac function

• Life expectancy ≥ 3 months

Exclusion Criteria:

• Evidence of bleeding diathesis or serious infection

• Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)

• Uncontrollable mental and nervous disorders

• Pregnant or lactating women