Recombinant Anti-tumor and Anti-virus Protein for Injection to Treat Advanced Neuroendocrine Tumors

NCT ID: NCT02455596

Last Updated: 2016-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-12-31

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection in treating patients with advanced neuroendocrine tumors who have failed standard treatment or are unable to receive standard treatment.

Detailed Description

This is a Phase Ⅱ exploratory clinical study. The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection in treating patients with advanced neuroendocrine tumors who have failed standard treatment or are unable to receive standard treatment.

Recombinant anti-tumor and anti-virus protein for injection, 10μg,im,3 times for the first week, followed by 20μg for two weeks, and followed a maintenance dose of 30μg, the frequency of administration is three times per week. Treatment continued until the patient died or had unacceptable toxicity or had disease progression or required to discontinue the treatment. At the time of disease progression, if investigators believe patients can continue to benefit from the investigational product, patients may be provided with recombinant anti-tumor and anti-virus protein for injection,but only survival follow-up datas will be recorded.

Conditions

Neuroendocrine Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Recombinant anti-tumor and anti-virus protein for injection(Novaferon), three times per week.

Group Type: EXPERIMENTAL

Recombinant anti-tumor and anti-virus protein for injection (Novaferon)

Intervention Type: DRUG

Recombinant anti-tumor and anti-virus protein for injection, 10μg, im, 3 times for first week,followed by 20μg for two weeks, and followed a maintenance dose of 30μg, the frequency of administration is three times per week.

Interventions

Recombinant anti-tumor and anti-virus protein for injection (Novaferon)

Recombinant anti-tumor and anti-virus protein for injection, 10μg, im, 3 times for first week,followed by 20μg for two weeks, and followed a maintenance dose of 30μg, the frequency of administration is three times per week.

Intervention Type: DRUG

Other Intervention Names

Novaferon

Eligibility Criteria

Inclusion Criteria

• Have been fully aware of the study and voluntarily signed the informed consent.
• At least 18 years old.
• Have a confirmed histological or cytological diagnosis of low- or intermediate-grade advanced NETs (unresectable or metastatic), the pathology must meet one of the following criteria: (a) primary site of lung or thymus (carcinoid) with mitotic count of ≤ 10/10 High Power Field [HPF]) (b) other primary site (including primary unknown) with mitotic count of ≤ 20/10 High Power Field [HPF] and Ki67 index of ≤ 20%，or with Ki67 index of > 20% and well-differentiated.
• Patients who have failed standard treatment or are unable to receive standard treatment, and have disease progression within the past 12 months;
• At least one measurable lesion according to the RECIST 1.1 criteria that has not been previously locally treated.
• ECOG performance status 0, 1 or 2.
• Minimum of 4 weeks since any local radiotherapy or surgery for the control of symptoms or severe complications(local radiotherapy for the control of bone metastases is not the limit)，and adequately recovered from toxicities of any prior therapy).
• Life expectancy of at least 3 months.

Exclusion Criteria

• Prior treatment with Recombinant Anti-tumor and Anti-virus Protein for Injection.
• Prior treatment with Interferon.
• Pregnancy or breast-feeding women or women who may be pregnant were positive drug test before administration.
• Patient of child-bearing potential(male or less than 1 year postmenopausal women) were reluctant to take contraceptive measures.
• Patient who were allergic to Interferon-α or who had interferon-α antibody.
• Have brain metastases or previous history of brain metastases or history of seizures.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xu Jianming, M.D.

Role: PRINCIPAL_INVESTIGATOR

307 Hospital of PLA

Locations

307 Hospital of PLA

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xu Jianming, M.D.

Role: CONTACT

jmxu2003@yahoo.com

+861051128358

Facility Contacts

Xu jianming

Role: primary

jmxu2003@yahoo.com

+861066947178

Other Identifiers

JH-NETs-001

Identifier Type: -

Identifier Source: org_study_id