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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
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stage IV Gastric Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 3, 2012
Last Updated
March 7, 2016
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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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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