A Phase I-c Study of Recombinant GM-CSF Herpes Simplex Virus to TreatⅣ M1c

September 29, 2017 updated by: OrienGene Biotechnology Ltd.

Recombinant Human GM-CSF Herpes Simplex Virus Injection (OrienX010) Standard Injection in Tumor Treatment Scheme Failed M1c Ⅳ Period Malignant Melanoma Spread to the Liver Open I-c Phase of Clinical Trial

Recombinant human GM-CSF herpes simplex virus injection (OrienX010) is a genetically engineered from Chinese patients oral separation of wild type 1 herpes simplex virus (HSV) as the carrier insert GM-CSF gene therapy drug.After gene recombination technology successively removing ICP34.5, ICP47 and insert the deactivation ICP6 gene, and at the site of the original ICP34.5 insert guided by IE promoter of hCMV human gm-csf gene.The drug after tumor site local injections of dosing, on the one hand, because of the soluble tumor characteristics of herpes simplex virus, reconstructing it after HSV-1 virus carrier at the injection site specific "soluble tumor" kill tumor cells;Viral vector expressed in tumor site, on the other hand, to produce high concentrations of GM-CSF enhance the antitumor immune function, play "beside the destruction effect", have inhibition effect on the distant metastases.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Subjects were tested drugs within 8 x 107 pfu/ml tumor injection treatment, the injection quantity according to tumor lesion size, injection amount shall not exceed 10 ml each time, injection frequency for every 2 weeks, 4 times per cycle treatment, treatment 2 cycles. Completed at the end of the second cycle after curative effect evaluation, such as the researchers determine continue to medicine can bring benefit to the subjects, can continue to offer benefits to the subjects' potential drug until disease progression, smaller, not tolerance toxicity or participants to withdraw consent.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100010
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
        • Contact:

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Melanoma Standard solution phase failure Ⅳ M1c malignant melanoma spread to the liver

Description

Inclusion Criteria:

  • By histological and/or cytology diagnosis Ⅳ M1c malignant melanoma patients with liver metastasis, the lack of an effective method for the conventional or the failure of conventional therapy or recurrence
  • General physical status score (ECOG) 0-2 points
  • Lifetime is expected to more than 4 months
  • Always anti-tumor treatment (including/radiation therapy, immune therapy, targeted therapy, endocrine therapy, etc.) to end more than 4 weeks (using the nitroso urea class and mitomycin chemotherapy drug withdrawal over 6 weeks), and always treat the adverse reaction of restored or stability

Exclusion Criteria:

  • In the group treated with other experimental drugs within 4 weeks before, but in the intervening clinical research (except such as epidemiological studies)
  • In group of four weeks before received the treatment of herpes simplex virus, such as acyclovir, ganciclovir, respectively.there is galloway, vidarabine, etc
  • In group of four weeks before too much surgery
  • Screening stage HSV - 1 antibody IgG and IgM are negative

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of tumor size
Time Frame: 16 weeks
According to RECIST1.1 method to evaluate the change of tumor size.
16 weeks

Collaborators and Investigators

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

Sponsor

OrienGene Biotechnology Ltd.

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 (Actual)

March 29, 2016

Primary Completion (Anticipated)

October 10, 2017

Study Completion (Anticipated)

October 28, 2019

Study Registration Dates

First Submitted

February 3, 2017

First Submitted That Met QC Criteria

February 6, 2017

First Posted (Estimate)

February 9, 2017

Study Record Updates

Last Update Posted (Actual)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OrienX010-II-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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