Endostatin Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

1)Preliminarily evaluate the treatment effect of continuous vein injection of recombinant human endostatin on NF2; 2)Preliminarily evaluate the safety and the patient's tolerance of the treatment of endostatin; 3)Provide an objective basis for an enlarged randomized double-blind trial.

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

Details

• Lead Sponsor: Beijing Tiantan Hospital
• Collaborator: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
• Treatments: Endostatins

Criteria

Inclusion Criteria:

• 1)Patients must be at the age of 16-30

• 2)Patients must meet the diagnostic criteria for NF2, with bilateral acoustic neuroma and other central nervous system tumors

• 3)Patients must not be treated with other drugs or radiation therapy recently

• 4)Patients should live in Beijing or nearby and can be treated in hospital

• 5)Patients must be healthy and not be seriously allergic with biological agents

• 6)Patients must join the clinical trial voluntarily, with good compliance, cooperate with the researchers well, sign a written informed consent.

Exclusion Criteria:

• 1)Treated with other drugs, surgery or radiation therapy recently

• 2)Brainstem is compressed seriously, with hydrocephalus, need to be treated with surgery in short time

• 3)Being pregnant or try to get pregnant, lactating women

• 4)With acute or chronic infectious diseases

• 5)With heart diseases, cardiac dysfunction or abnormal ECG

• 6)With uncontrolled neural or mental diseases, poor compliance

• 7)Not available for enhanced MRI

• 8)Take part in any other clinical trial

• 9)With other conditions that are considered not suitable for this clinical trial.