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

Phase 1CompletedNCT01935453

OrienGene Biotechnology Ltd.18 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Melanoma Liver Cancer Pancreatic Cancer Lung Cancer

Interventions

Recombinant hGM-CSF Herpes Simplex Virus InjectionBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 (2)

Beijing Shijitan Hospital,CMU

Beijing, Beijing Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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 Outcomes

Using RECIST 1.1 to evaluate the preliminary efficacy of OrienX010

Time frame: 28 days after the last administration

Data from ClinicalTrials.gov

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