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

Phase 1

Completed

• Conditions: Melanoma; Liver Cancer; Pancreatic Cancer; Lung Cancer
• Interventions: Biological: Recombinant hGM-CSF Herpes Simplex Virus Injection

• Registration Number: NCT01935453
• Lead Sponsor: OrienGene Biotechnology Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-12
• Study Start: 2012-05
• Study First Submitted: 2013-08-23
• Study First Submitted QC: 2013-08-30
• Study First Posted: 2013-09-05
• Primary Completion: 2014-05
• Last Update Submitted: 2016-08-31
• Last Update Posted: 2016-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Recombinant HSV-1 Injection	Recombinant hGM-CSF Herpes Simplex Virus 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Using RECIST 1.1 to evaluate the preliminary efficacy of OrienX010	28 days after the last administration

Trial Locations

Locations (2)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China

Beijing Shijitan Hospital,CMU; 🇨🇳 Beijing, Beijing, China