Back to resultsRecombinant Anti-tumor and Anti-virus Protein for Injection to Treat Advanced Neuroendocrine Tumors
Primary Purpose
Neuroendocrine Tumors
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Recombinant anti-tumor and anti-virus protein for injection (Novaferon)
Sponsored by
About this trial
This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring Novaferon, Recombinant anti-tumor and anti-virus protein for injection, Carcinoid Tumor, Pancreatic Neuroendocrine Tumor
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.
Sites / Locations
- 307 Hospital of PLARecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Recombinant anti-tumor and anti-virus protein for injection(Novaferon), three times per week.
Outcomes
Primary Outcome Measures
Progression-free survival (PFS)
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)
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
Overall response rate(ORR)
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)
OS is defined as the length of time from random assignment to death or to last contact
Adverse Events(AEs)
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Full Information
NCT ID
NCT02455596
First Posted
May 21, 2015
Last Updated
January 4, 2016
Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02455596
Brief Title
Recombinant Anti-tumor and Anti-virus Protein for Injection to Treat Advanced Neuroendocrine Tumors
Official Title
Phase II Study of Recombinant Anti-tumor and Anti-virus Protein for Injection to Treat Advanced Neuroendocrine Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
Keywords
Novaferon, Recombinant anti-tumor and anti-virus protein for injection, Carcinoid Tumor, Pancreatic Neuroendocrine Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Recombinant anti-tumor and anti-virus protein for injection(Novaferon), three times per week.
Intervention Type
Drug
Intervention Name(s)
Recombinant anti-tumor and anti-virus protein for injection (Novaferon)
Other Intervention Name(s)
Novaferon
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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.
Time Frame
1 year
Title
Disease control rate(DCR)
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall response rate(ORR)
Description
ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.
Time Frame
1 year
Title
Overall survival (OS)
Description
OS is defined as the length of time from random assignment to death or to last contact
Time Frame
3 years
Title
Adverse Events(AEs)
Description
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xu Jianming, M.D.
Phone
+861051128358
Email
jmxu2003@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu Jianming, M.D.
Organizational Affiliation
307 Hospital of PLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
307 Hospital of PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu jianming
Phone
+861066947178
Email
jmxu2003@yahoo.com
First Name & Middle Initial & Last Name & Degree
xu jianming, M.D.
12. IPD Sharing Statement
Learn more about this trial
Recombinant Anti-tumor and Anti-virus Protein for Injection to Treat Advanced Neuroendocrine Tumors
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