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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03048253
• Other study ID #: OrienX010-II-10
• Status: Recruiting
• Phase: N/A
• First received: February 3, 2017
• Last updated: September 29, 2017
• Start date: March 29, 2016
• Est. completion date: October 28, 2019

Study information

• Verified date: February 2017
• Source: OrienGene Biotechnology Ltd.
• Contact: Zinan Xiao, MD
• Phone: +86-15101193329
• Email: znxiao[@]Oriengene.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 28, 2019
• Est. primary completion date: October 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• By histological and/or cytology diagnosis ? 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

Related Conditions & MeSH terms

• Herpes Simplex
• Melanoma

Intervention

Biological:
• OrienX010
Beijing biological technology co., LTD. Research and development of the source and force of recombinant human GM-CSF herpes simplex virus injection (OrienX010), is a genetically engineered type 1 herpes simplex virus (HSV - 1) as the carrier insert GM-CSF gene therapy drug.Its carrier is made of isolated from patients with oral Chinese wild single blister virus type I (CL1), 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.

Locations

Country	Name	City	State
China	Beijing cancer hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
OrienGene Biotechnology Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of tumor size	According to RECIST1.1 method to evaluate the change of tumor size.	16 weeks