Status:
UNKNOWN
Trial of E10A in Head and Neck Cancer
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Doublle Bioproduct Inc
Conditions:
Head and Neck Squamous Carcinoma
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00634595
Start Date
March 1 2008
End Date
December 1 2010
Last Update
July 28 2010
Active Locations (1)
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1
Cancer center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060