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

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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

Tracking Information
First Submitted Date  ICMJE May 21, 2015
First Posted Date  ICMJE May 28, 2015
Last Update Posted Date January 5, 2016
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2015)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2015)
  • 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.
  • Overall survival (OS) [ Time Frame: 3 years ]
    OS is defined as the length of time from random assignment to death or to last contact
  • Adverse Events(AEs) [ Time Frame: 1 year ]
    AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Recombinant Anti-tumor and Anti-virus Protein for Injection to Treat Advanced Neuroendocrine Tumors
Official Title  ICMJE Phase II Study of Recombinant Anti-tumor and Anti-virus Protein for Injection to Treat Advanced Neuroendocrine Tumors
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Experimental
Recombinant anti-tumor and anti-virus protein for injection(Novaferon), three times per week.
Intervention: Drug: Recombinant anti-tumor and anti-virus protein for injection (Novaferon)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 27, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02455596
Other Study ID Numbers  ICMJE JH-NETs-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Study Sponsor  ICMJE The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xu Jianming, M.D. 307 Hospital of PLA
PRS Account The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP