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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

Tracking Information
First Submitted Date  ICMJE March 5, 2008
First Posted Date  ICMJE March 13, 2008
Last Update Posted Date July 28, 2010
Study Start Date  ICMJE March 2008
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2008)
tumor response confirmed by CT or MRI [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2008)
NCI toxicity criteria (CIC 3.0) [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of E10A in Head and Neck Cancer
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Head and Neck Squamous Carcinoma
  • Nasopharyngeal Carcinoma
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: A
    E10A combined with Cisplatin and Paclitaxel
    Interventions:
    • Drug: E10A
    • Drug: Cisplatin
    • Drug: Paclitaxel
  • Active Comparator: B
    Cisplatin and Paclitaxel
    Interventions:
    • Drug: Cisplatin
    • Drug: Paclitaxel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 5, 2008)
116
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2010
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00634595
Other Study ID Numbers  ICMJE TG0717E10A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wenqi Jiang, Professor, Cancer center, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Doublle Bioproduct Inc
Investigators  ICMJE
Principal Investigator: Wenqi Jiang Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP