Trial of E10A in Head and Neck Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Doublle Bioproduct Inc
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00634595
First received: March 5, 2008
Last updated: July 26, 2010
Last verified: July 2010
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NCI toxicity criteria (CIC 3.0) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00634595

Contacts
Contact: Xubin Lin, MD, PhD 86-20-87343355 linxubin@mail.sysu.edu.cn

Locations
China, Guangdong
Cancer center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Xubin Lin, MD, PhD       linxubin@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-sen University
Doublle Bioproduct Inc
Investigators
Principal Investigator: Wenqi Jiang Sun Yat-sen University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wenqi Jiang, Professor, Cancer center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00634595     History of Changes
Other Study ID Numbers: TG0717E10A
Study First Received: March 5, 2008
Last Updated: July 26, 2010
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Paclitaxel
Endostatins
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on July 26, 2014