Trial of E10A in Head and Neck Cancer
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
1 other identifier
interventional
116
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2008
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 5, 2008
CompletedFirst Posted
Study publicly available on registry
March 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJuly 28, 2010
July 1, 2010
2.8 years
March 5, 2008
July 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
tumor response confirmed by CT or MRI
3 months
Secondary Outcomes (1)
NCI toxicity criteria (CIC 3.0)
3 months
Study Arms (2)
A
EXPERIMENTALE10A combined with Cisplatin and Paclitaxel
B
ACTIVE COMPARATORCisplatin and Paclitaxel
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sun Yat-sen Universitylead
- Doublle Bioproduct Inccollaborator
Study Sites (1)
Cancer center, Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
Related Publications (2)
Lin X, Huang H, Li S, Li H, Li Y, Cao Y, Zhang D, Xia Y, Guo Y, Huang W, Jiang W. A phase I clinical trial of an adenovirus-mediated endostatin gene (E10A) in patients with solid tumors. Cancer Biol Ther. 2007 May;6(5):648-53. doi: 10.4161/cbt.6.5.4004. Epub 2007 Feb 13.
PMID: 17426445BACKGROUNDYe W, Liu R, Pan C, Jiang W, Zhang L, Guan Z, Wu J, Ying X, Li L, Li S, Tan W, Zeng M, Kang T, Liu Q, Thomas GR, Huang M, Deng W, Huang W. Multicenter randomized phase 2 clinical trial of a recombinant human endostatin adenovirus in patients with advanced head and neck carcinoma. Mol Ther. 2014 Jun;22(6):1221-1229. doi: 10.1038/mt.2014.53. Epub 2014 Mar 25.
PMID: 24662947DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wenqi Jiang
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 5, 2008
First Posted
March 13, 2008
Study Start
March 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
July 28, 2010
Record last verified: 2010-07