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

NCT00262327 | Unknown Phase 1

• 2 other identifiers: DB-101E10A
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Advanced Solid Tumor

Keywords

antiangiogenesis; endostatin; adenovirus; gene therapy; cancer

Interventions

Antangiogenesis DRUG

endostatin gene GENETIC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Doublle Bioproduct Inc: collaborator

Study Sites (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Adenoviridae Infections; Neoplasms

Interventions

Endostatins

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Study Officials

• Wenqi Jiang, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 2, 2005
• First Posted: December 6, 2005
• Study Start: May 1, 2005
• Study Completion: February 1, 2006
• Last Updated: June 20, 2006

Record last verified: 2005-12

Locations

CN (1)