A Phase I Study Of Recombinant HGM-CSF Herpes Simplex Virus To Treat Cancer

Study Overview

A Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus to Treat Cancer

The main purpose of this study is to study the safety of OrienX010 in the treatment of kinds of solid tumors such as melanoma,liver cancer,pancreatic cancer and lung cancer.

N/A

Melanoma
Liver Cancer
Pancreatic Cancer
Lung Cancer

BIOLOGICAL: Recombinant hGM-CSF Herpes Simplex Virus Injection

OrienGene-01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-08-23	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-08-31
First Submitted that Met QC Criteria 2013-08-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-09-01
First Posted (ESTIMATED) 2013-09-05	Results First Posted N/A	Last Verified 2011-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Recombinant HSV-1 Injection Intratumoral injection Single dose: 4 groups -- 106 pfu, 107 pfu, 108 pfu and 4×108 pfu Multiple dose (three injections, every 2 weeks): 2 groups -- 108, 108, 108pfu and 4×108, 4×108, 4×108pfu Continuous treatment: Upon 4 weeks follow-up after administrat	BIOLOGICAL: Recombinant hGM-CSF Herpes Simplex Virus Injection

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Recombinant HSV-1 Injection

Intratumoral injection Single dose: 4 groups -- 106 pfu, 107 pfu, 108 pfu and 4×108 pfu Multiple dose (three injections, every 2 weeks): 2 groups -- 108, 108, 108pfu and 4×108, 4×108, 4×108pfu Continuous treatment: Upon 4 weeks follow-up after administrat

BIOLOGICAL: Recombinant hGM-CSF Herpes Simplex Virus Injection

Primary Outcome Measures	Measure Description	Time Frame
Exploring the MTD of OrienX010 according to DLT,which defined as the serious degree of adverse events relates to the medicine not less than grade 3 of CTCAE v4.03		28 days after the last administration

Secondary Outcome Measures	Measure Description	Time Frame
Using RECIST 1.1 to evaluate the preliminary efficacy of OrienX010		28 days after the last administration

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

patients in advanced stage of malignant tumor diagnosticated by pathologic and cytological analysis.
lack of routine effective treatment,failure of routine treatment or relapse
age of 18-70,ECOG 0-2 and estimated survival is above 3 months
had an interval of above 4 weeks since exposure to chemotherapy or radiotherapy and above 6 weeks since exposure to nitrosoureas or mitomycin C.

Serious internal diseases
uncontrolled primary and metastatic brain tumor
sizes of tumor does not meet the requirement of injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

START Shanghai
Beijing Bozhiyin T&S Co., Ltd.

Investigators

PRINCIPAL_INVESTIGATOR: Jin Li, MD, Fudan University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record