Clinical trial NCT02455596: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neuroendocrine Tumors
Keywords: Novaferon
Recombinant anti-tumor and anti-virus protein for injection
Carcinoid Tumor
Pancreatic Neuroendocrine Tumor
Lead sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2015-05-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 1 year
measure: Disease control rate(DCR)
timeFrame: 1 year
Secondary outcomes:
measure: Overall response rate(ORR)
timeFrame: 1 year
measure: Overall survival (OS)
timeFrame: 3 years
measure: Adverse Events(AEs)
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: 307 Hospital of PLA
state: Beijing
Study officials:
affiliation: 307 Hospital of PLA
name: Xu Jianming, M.D.
role: PRINCIPAL_INVESTIGATOR
References: