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Trial of E10A in Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00634595
Recruitment Status : Unknown
Verified July 2010 by Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : March 13, 2008
Last Update Posted : July 28, 2010
Sponsor:
Collaborator:
Doublle Bioproduct Inc
Information provided by:
Sun Yat-sen University

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Head and Neck Squamous Carcinoma Nasopharyngeal Carcinoma Drug: E10A Drug: Cisplatin Drug: Paclitaxel Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
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
Study Start Date : March 2008
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634595


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

Locations
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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
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Principal Investigator: Wenqi Jiang Sun Yat-sen University
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wenqi Jiang, Professor, Cancer center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00634595    
Other Study ID Numbers: TG0717E10A
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: July 28, 2010
Last Verified: July 2010
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:
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Carcinoma
Head and Neck Neoplasms
Nasopharyngeal Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Nasopharyngeal Diseases
 Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Neoplasms, Squamous Cell
Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action