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

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ClinicalTrials.gov Identifier: NCT01637805
Recruitment Status : Unknown
Verified July 2012 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Active, not recruiting
First Posted : July 11, 2012
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

July 3, 2012
July 11, 2012
March 8, 2016
May 2012
October 2016   (Final data collection date for primary outcome measure)
Objective response rate [ Time Frame: Up to 12 months ]
CR + PR = ORR
Same as current
Complete list of historical versions of study NCT01637805 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Clinical Safety and Preliminary Efficacy of AAV-DC-CTL Treatment in Stage IV Gastric Cancer
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
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Stage IV Gastric Cancer
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
Experimental: AAV-DC-CTL
Intervention: Biological: Antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
Same as current
December 2016
October 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01637805
CIH-ZRP-201205001
Not Provided
Not Provided
Not Provided
Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Cancer Institute and Hospital
Not Provided
Not Provided
Tianjin Medical University Cancer Institute and Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP