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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Melanoma Liver Cancer Pancreatic Cancer Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Recombinant HSV-1 Injection

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.

Group Type EXPERIMENTAL

Recombinant hGM-CSF Herpes Simplex Virus Injection

Intervention Type BIOLOGICAL

Interventions

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Recombinant hGM-CSF Herpes Simplex Virus Injection

Intervention Type BIOLOGICAL

Other Intervention Names

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OrienX010

Eligibility Criteria

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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.