Clinical Safety and Preliminary Efficacy of AAV-DC-CTL Treatment in Stage IV Gastric Cancer

Stage IV Gastric Cancer Clinical Trial

— AAV-DC-CTL  

Official title:

Phase 1 Study of Antigen-specific Cytotoxic T Lymphocytes Induced by Dendritic Cells Infected by Recombinant Adeno-associated Virus With CEA Gene in Stage IV Gastric Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01637805
• Other study ID #: CIH-ZRP-201205001
• Status: Active, not recruiting
• Phase: Phase 1
• First received: July 3, 2012
• Last updated: March 7, 2016
• Start date: May 2012
• Est. completion date: December 2016

Study information

• Verified date: July 2012
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Institutional Review Board of Tianjin Cancer Hospital
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical safety and preliminary efficacy of antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene in the treatment of stage IV gastric cancer patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Sex: male or female

• Age: from 18 to 80 years

• Histology: gastric cancer

• Clinical stage: stage IV

• Karnofsky performance status: more than 50%

• Expected survival: more than 2 months

• Sex: male or female

• Laboratory tests results 7 days before the start of treatment:

• White blood cells: more than 3.0 × 109/L

• Platelets: more than 100 × 109/L

• Neutrophils: more than 1.5 × 109/L

• Hemoglobin: more than 80g/L

• Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN)

• Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN

• Serum bilirubin: less than 1.25 × ULN

• Serum creatinine: less than 1.25 × ULN

• Pregnancy test: the test of women of child-bearing period must be negative 7 days before the start of treatment

• Contraception: male and female subjects of child-bearing period must adopt a reliable method of contraception before entry into this study until 30 days after stopping this study

• Informed consent: subject must have the ability to understand and voluntarily sign a written informed consent

Exclusion Criteria:

• History of neoplasms: other neoplasms

• Medical history: mental disease, or congestive heart failure, or severe coronary artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy

• Metastasis: clinical symptoms of brain metastasis

• Other clinical trial: the subject received other clinical trial before this study

• Laboratory tests: the serum test of human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus was positive

• Woman: pregnant or lactating women

• Compliance: poor compliance

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Stage IV Gastric Cancer
• Stomach Neoplasms

Intervention

Biological:
• Antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene
AAV-DC-CTL: Intravenous infusion, 1×109 cells, day 14; one cycle every month; at least one cycle

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	CR + PR = ORR	Up to 12 months	Yes