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

NCT ID: NCT01637805

Last Updated: 2016-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2016-12-31

Brief 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.

Conditions

Stage IV Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

AAV-DC-CTL

Group Type: EXPERIMENTAL

Antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene

Intervention Type: BIOLOGICAL

AAV-DC-CTL: Intravenous infusion, 1×109 cells, day 14; one cycle every month; at least one cycle

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

CIH-ZRP-201205001

Identifier Type: -

Identifier Source: org_study_id