Status:
UNKNOWN
Safety and Efficacy of Adenoviral Endostatin in the Treatment of Advanced Solid Tumor
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Doublle Bioproduct Inc
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The growth and metastasis of solid tumors are dependent on angiogenesis. Endostatin, the C-terminal proteolytic fragment of collagen XVIII, is an effective endogenous angiogenesis inhibitor in cancer ...
Detailed Description
It is widely recognized that angiogenesis not only is important in physiological processes such as embryonic development, wound healing, and organ and tissue regeneration, but also play a pivotal role...
Eligibility Criteria
Inclusion
- Age between 18 and 65 years;
- Genders eligible for study: both;
- Histologic diagnosis of solid malignancies ;
- Performance status of 0 or 1;
- Tumor not amenable to standard curative or palliative therapy;
- An accessible tumor mass;
- At least 4 weeks since prior biotherapy/chemotherapy/radiotherapy;
- A life expectancy beyond 3 months;
- Ability to give signed informed consent.
Exclusion
- Pregnancy or lactation;
- Had a history of brain metastasis or a primary brain tumor;
- An active, potentially severe autoimmune disease;
- Serum creatinine ≥1.5mg/dl or a calculated creatinine clearance \<60ml/min;
- WBC count \< 2.0×109/L，hemoglobin \< 90g/L，and platelet count \< 100×109/L;
- Total bilirubin value \< 2.0 times the upper limit of normal (ULN), ALT level \< 2.0 times ULN, AST \< 2.0 times ULN;
- Positive of anti-HIV antibodies;
- An active bacterial, fungal, or viral infection;
- Less than one month since prior systemic immunosuppressive drugs.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00262327
Start Date
May 1 2005
End Date
February 1 2006
Last Update
June 20 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060