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

OrienGene Biotechnology

Status and phase: Completed; Phase 1

Conditions: Melanoma; Lung Cancer; Liver Cancer; Pancreatic Cancer

Treatments: Biological: Recombinant hGM-CSF Herpes Simplex Virus Injection

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01935453

OrienGene-01

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Recombinant HSV-1 Injection

Experimental group

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.

Treatment:

Biological: Recombinant hGM-CSF Herpes Simplex Virus Injection