Overview

This trial is active, not recruiting.

Condition stage iv gastric cancer
Treatment antigen-specific cytotoxic t lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with cea gene
Phase phase 1
Sponsor Tianjin Medical University Cancer Institute and Hospital
Start date May 2012
End date October 2016
Trial size 30 participants
Trial identifier NCT01637805, CIH-ZRP-201205001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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

Primary Outcomes

Measure
Objective response rate
time frame: Up to 12 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Tianjin Medical University Cancer Institute and Hospital.