Safety and Efficacy of Adenoviral Endostatin in the Treatment of Advanced Solid Tumor

• Status: Unknown status
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

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 therapy in mice. Applied for clinical studies in solid tumor, however, recombinant human endostatin protein, difficulties in a large-scale production of the recombinant endostatin protein, and the cumbersome daily administration. Up to now, its clinical application has been hampered by those matters. We herein constructed a adenoviral vector ecoding human endostatin. This study will test the safety and efficacy of recombinant human endostatin adenovirus (Ad-rhE) in the treatment of patients with advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborator: Doublle Bioproduct Inc
• Treatments: Endostatins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.