Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2807 for:    Neoplasms | Neuroendocrine Tumors

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02455596
Recruitment Status : Unknown
Verified October 2015 by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences.
Recruitment status was:  Recruiting
First Posted : May 28, 2015
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: Recombinant anti-tumor and anti-virus protein for injection (Novaferon) Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Recombinant Anti-tumor and Anti-virus Protein for Injection to Treat Advanced Neuroendocrine Tumors
Study Start Date : May 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: Experimental
Recombinant anti-tumor and anti-virus protein for injection(Novaferon), three times per week.
Drug: 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.
Other Name: Novaferon




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 1 year ]
    PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.

  2. Disease control rate(DCR) [ Time Frame: 1 year ]
    DCR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments.


Secondary Outcome Measures :
  1. Overall response rate(ORR) [ Time Frame: 1 year ]
    ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.

  2. Overall survival (OS) [ Time Frame: 3 years ]
    OS is defined as the length of time from random assignment to death or to last contact

  3. Adverse Events(AEs) [ Time Frame: 1 year ]
    AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02455596


Contacts
Layout table for location contacts
Contact: Xu Jianming, M.D. +861051128358 jmxu2003@yahoo.com

Locations
Layout table for location information
China, Beijing
307 Hospital of PLA Recruiting
Beijing, Beijing, China, 100071
Contact: Xu jianming    +861066947178    jmxu2003@yahoo.com   
Principal Investigator: xu jianming, M.D.         
Sponsors and Collaborators
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Investigators
Layout table for investigator information
Principal Investigator: Xu Jianming, M.D. 307 Hospital of PLA

Layout table for additonal information
Responsible Party: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT02455596     History of Changes
Other Study ID Numbers: JH-NETs-001
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: October 2015
Keywords provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:
Novaferon
Recombinant anti-tumor and anti-virus protein for injection
Carcinoid Tumor
Pancreatic Neuroendocrine Tumor
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents