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

This study has been completed.
Sponsor:
Collaborators:
START Shanghai
Beijing Bozhiyin T&S Co., Ltd.
Information provided by (Responsible Party):
OrienGene Biotechnology Ltd.
ClinicalTrials.gov Identifier:
NCT01935453
First received: August 23, 2013
Last updated: August 31, 2016
Last verified: December 2011
  Purpose
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.

Condition Intervention Phase
Melanoma
Liver Cancer
Pancreatic Cancer
Lung Cancer
Biological: Recombinant hGM-CSF Herpes Simplex Virus Injection
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus

Resource links provided by NLM:


Further study details as provided by OrienGene Biotechnology Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Using RECIST 1.1 to evaluate the preliminary efficacy of OrienX010 [ Time Frame: 28 days after the last administration ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: May 2012
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: OrienX010

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01935453

Locations
China, Beijing
Beijing Shijitan Hospital,CMU
Beijing, Beijing, China, 100038
China, Shanghai
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
OrienGene Biotechnology Ltd.
START Shanghai
Beijing Bozhiyin T&S Co., Ltd.
Investigators
Principal Investigator: Jin Li, MD Fudan University
Principal Investigator: Jun Ren, MD Beijing Shijitan Hospital,CMU
  More Information

Responsible Party: OrienGene Biotechnology Ltd.
ClinicalTrials.gov Identifier: NCT01935453     History of Changes
Other Study ID Numbers: OrienGene-01 
Study First Received: August 23, 2013
Last Updated: August 31, 2016
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Pancreatic Neoplasms
Liver Neoplasms
Herpes Simplex
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Liver Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2016