A Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus to Treat Cancer
Conditions
Melanoma - Liver Cancer - Pancreatic Cancer - Lung Cancer
Conditions: official terms
Herpes Simplex - Pancreatic Neoplasms
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Recombinant hGM-CSF Herpes Simplex Virus Injection
Type: Biological
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
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
Locations
Beijing Shijitan Hospital,CMU
Beijing, Beijing, China
Status: Recruiting
Contact: Xinna Zhou - 86-10-63926220
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China
Status: Recruiting
Contact: Jin Li, MD - fudanlijin@163.com
Start Date
May 2012
Completion Date
December 2013
Sponsors
OrienGene Biotechnology Ltd.
Source
OrienGene Biotechnology Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page