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Trial of E10A in Head and Neck Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Sun Yat-sen University.
Recruitment status was:  Recruiting
Doublle Bioproduct Inc
Information provided by:
Sun Yat-sen University Identifier:
First received: March 5, 2008
Last updated: July 26, 2010
Last verified: July 2010

Angiogenesis, the formation of new blood vessel from existing vessels, is essential for tumor growth and metastasis. Antiangiogenic therapies inhibit the growth of genetically stable endothelial cells, and most tumors should starve to death with little acquired resistance. Endostatin has been shown to block endothelial cell proliferation, survival, and migration. Antitumor activity of endostatin protein has been demonstrated in various murine and human tumors in animal model studies without any detectable toxicity. Endostatin gene therapy could directly express the highly bioactive protein in vivo by means of the mechanism of eukaryotic expression system as post-translational modification and folding, as well as overcoming the challenge of the long-term storage and the cumbersome daily administration of endostatin protein.

E10A is a replication-deficient recombinant adenovirus containing a wild-type human endostatin transgene constructed from serotype 5 adenovirus (Ad5). Preclinical studies demonstrated that intratumoral injection of E10A provided significant tumor growth inhibition and sustained elevation of endostatin in blood and tumor tissue in hepatocellular carcinoma, nasopharyngeal carcinoma, and tongue cancer animal models. A Phase I clinical trial of E10A we conducted showed that repetitive intratumoral injection of E10A resulted in a small and sustained elevation of endostatin in blood and had a mild antitumor activities with very limited toxicity. The major toxicity was transient and manageable fever. A randomized Phase III trial in nonsmall-cell lung cancer showed endostatin improved response rate and time to tumor progression in combination to chemotherapy. Therefore, we designed a randomized phase II trial to explore the safety and effectiveness of E10A combined with chemotherapy in the treatment of patients with head and neck cancer.

Condition Intervention Phase
Head and Neck Squamous Carcinoma Nasopharyngeal Carcinoma Drug: E10A Drug: Cisplatin Drug: Paclitaxel Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Clinical Trial of an Adenovirus-mediated Endostatin Gene (E10A) Combined With Cisplatin and Paclitaxel in Patients With Head and Neck Cancer

Resource links provided by NLM:

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • tumor response confirmed by CT or MRI [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • NCI toxicity criteria (CIC 3.0) [ Time Frame: 3 months ]

Estimated Enrollment: 116
Study Start Date: March 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
E10A combined with Cisplatin and Paclitaxel
Drug: E10A
E10A 1*10(12)VP, intratumoral injection, d1 d8, repeat every 3 weeks for 4 cycles
Drug: Cisplatin
25 mg/m2/d ivd d3 d4 d5, repeat every 3 weeks for 4 cycles.
Drug: Paclitaxel
160 mg/m2 ivd d3, repeat every 3 weeks for 4 cycles.
Active Comparator: B
Cisplatin and Paclitaxel
Drug: Cisplatin
25 mg/m2/d ivd d3 d4 d5, repeat every 3 weeks for 4 cycles.
Drug: Paclitaxel
160 mg/m2 ivd d3, repeat every 3 weeks for 4 cycles.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • histologically or cytologically confirmed recurrent or metastatic head and neck squamous carcinoma or nasopharyngeal carcinoma
  • the tumor was amenable to direct injection and measurement ( > 2 cm)
  • an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • a life expectancy over three months
  • the absence of serious medical or psychiatric disorders
  • serum creatinine < 1.5 mg/dL; WBC count >3,000/mm3, platelet count > 80,000/mm3, hemoglobin > 8 g/dL; total bilirubin value < 1.5 times the upper limit of normal [ULN], ALT level < 2.5 times ULN, AST < 2.5 times ULN.

Exclusion Criteria:

  • pregnant or breast feeding
  • a history of brain metastases or a primary brain tumor
  • a history of hemorrhagic diathesis
  • a history of corticosteroids or immunosuppressives use within four weeks of study entry
  • a history of immune deficiency disorder or organ transplant
  • has evidence of active adenovirus infection or uncontrolled infection
  • received any chemotherapy or radiotherapy within four weeks of study entry
  Contacts and Locations
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Please refer to this study by its identifier: NCT00634595

Contact: Xubin Lin, MD, PhD 86-20-87343355

China, Guangdong
Cancer center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Xubin Lin, MD, PhD   
Sponsors and Collaborators
Sun Yat-sen University
Doublle Bioproduct Inc
Principal Investigator: Wenqi Jiang Sun Yat-sen University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Wenqi Jiang, Professor, Cancer center, Sun Yat-sen University Identifier: NCT00634595     History of Changes
Other Study ID Numbers: TG0717E10A
Study First Received: March 5, 2008
Last Updated: July 26, 2010

Keywords provided by Sun Yat-sen University:
clinical trial
gene therapy
head and neck cancer
head and neck squamous carcinoma

Additional relevant MeSH terms:
Head and Neck Neoplasms
Nasopharyngeal Neoplasms
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Neoplasms, Squamous Cell
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors processed this record on August 22, 2017