Back to resultsA Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus to Treat Cancer
Primary Purpose
Melanoma, Liver Cancer, Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Recombinant hGM-CSF Herpes Simplex Virus Injection
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
Eligibility 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
Sites / Locations
- Beijing Shijitan Hospital,CMU
- Fudan University Shanghai Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Recombinant HSV-1 Injection
Arm Description
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.
Outcomes
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
Secondary Outcome Measures
Using RECIST 1.1 to evaluate the preliminary efficacy of OrienX010
Full Information
NCT ID
NCT01935453
First Posted
August 23, 2013
Last Updated
August 31, 2016
Sponsor
OrienGene Biotechnology Ltd.
Collaborators
START Shanghai, Beijing Bozhiyin T&S Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01935453
Brief Title
A Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus to Treat Cancer
Official Title
A Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OrienGene Biotechnology Ltd.
Collaborators
START Shanghai, Beijing Bozhiyin T&S Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Liver Cancer, Pancreatic Cancer, Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Recombinant HSV-1 Injection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Recombinant hGM-CSF Herpes Simplex Virus Injection
Other Intervention Name(s)
OrienX010
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Using RECIST 1.1 to evaluate the preliminary efficacy of OrienX010
Time Frame
28 days after the last administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Li, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jun Ren, MD
Organizational Affiliation
Beijing Shijitan Hospital,CMU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Shijitan Hospital,CMU
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100038
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus to Treat Cancer
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