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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935453
• Other study ID #: OrienGene-01
• Status: Completed
• Phase: Phase 1
• First received: August 23, 2013
• Last updated: August 31, 2016
• Start date: May 2012

Study information

• Verified date: December 2011
• Source: OrienGene Biotechnology Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Simplex
• Liver Cancer
• Liver Neoplasms
• Lung Cancer
• Melanoma
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• Recombinant hGM-CSF Herpes Simplex Virus Injection

Locations

Country	Name	City	State
China	Beijing Shijitan Hospital,CMU	Beijing	Beijing
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
OrienGene Biotechnology Ltd.	Beijing Bozhiyin T&S Co., Ltd., START Shanghai

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Using RECIST 1.1 to evaluate the preliminary efficacy of OrienX010		28 days after the last administration	Yes