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

NCT01935453 | Completed Phase 1

• 1 other identifier: OrienGene-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Melanoma; Liver Cancer; Pancreatic Cancer; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  28 days after the last administration

Secondary Outcomes (1)

• Using RECIST 1.1 to evaluate the preliminary efficacy of OrienX010

  28 days after the last administration

Study Arms (1)

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.

Biological: Recombinant hGM-CSF Herpes Simplex Virus Injection

Interventions

Recombinant hGM-CSF Herpes Simplex Virus Injection BIOLOGICAL

Also known as: OrienX010

Recombinant HSV-1 Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Serious internal diseases
• uncontrolled primary and metastatic brain tumor
• sizes of tumor does not meet the requirement of injection

Sponsors & Collaborators

• OrienGene Biotechnology Ltd.: lead
• START Shanghai: collaborator
• Beijing Bozhiyin T&S Co., Ltd.: collaborator

Study Sites (2)

Beijing Shijitan Hospital,CMU

Beijing, Beijing Municipality, 100038, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Melanoma; Liver Neoplasms; Pancreatic Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jin Li, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

• Jun Ren, MD

  Beijing Shijitan Hospital,CMU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: September 5, 2013
• Study Start: May 1, 2012
• Primary Completion: May 1, 2014
• Last Updated: September 1, 2016

Record last verified: 2011-12

Locations

CN (2)