Clinical Safety and Preliminary Efficacy of AAV-DC-CTL Treatment in Stage IV Gastric Cancer (AAV-DC-CTL)
Primary Purpose
Stage IV Gastric Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene
Sponsored by
About this trial
This is an interventional supportive care trial for Stage IV Gastric Cancer
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
Sites / Locations
- Tianjin Medical University Cancer Institute and Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AAV-DC-CTL
Arm Description
Outcomes
Primary Outcome Measures
Objective response rate
CR + PR = ORR
Secondary Outcome Measures
Full Information
NCT ID
NCT01637805
First Posted
July 3, 2012
Last Updated
March 7, 2016
Sponsor
Tianjin Medical University Cancer Institute and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01637805
Brief Title
Clinical Safety and Preliminary Efficacy of AAV-DC-CTL Treatment in Stage IV Gastric Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Gastric Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AAV-DC-CTL
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene
Intervention Description
AAV-DC-CTL: Intravenous infusion, 1×109 cells, day 14; one cycle every month; at least one cycle
Primary Outcome Measure Information:
Title
Objective response rate
Description
CR + PR = ORR
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
12. IPD Sharing Statement
Learn more about this trial
Clinical Safety and Preliminary Efficacy of AAV-DC-CTL Treatment in Stage IV Gastric Cancer
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