Trial | NCT01935453  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    18
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.
Study Started
May 31
2012
Primary Completion
May 31
2014
Last Update
Sep 01
2016
Estimate

Biological Recombinant hGM-CSF Herpes Simplex Virus Injection

  • Other names: OrienX010

Recombinant HSV-1 Injection Experimental

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.

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
No Results Posted