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

August 31, 2016 updated by: OrienGene Biotechnology Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100038
        • Beijing Shijitan Hospital,CMU
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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 administration, if the investigator deems that continuous treatment will benefit subjects, continuous intratumoral injection may be given, and the interval between each injection will be 2 weeks.
Biological: Recombinant hGM-CSF Herpes Simplex Virus Injection
Other Names:
  • OrienX010

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 28 days after the last administration
28 days after the last administration

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

OrienGene Biotechnology Ltd.

Collaborators

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

Investigators

  • Principal Investigator: Jin Li, MD, Fudan University
  • Principal Investigator: Jun Ren, MD, Beijing Shijitan Hospital,CMU

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 Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

August 23, 2013

First Submitted That Met QC Criteria

August 30, 2013

First Posted (Estimate)

September 5, 2013

Study Record Updates

Last Update Posted (Estimate)

September 1, 2016

Last Update Submitted That Met QC Criteria

August 31, 2016

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OrienGene-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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