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

Sponsor

Tianjin Medical University Cancer Institute and Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01637805

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stage IV Gastric Cancer	Biological: Antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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 Start Date :

May 1, 2012

Anticipated Primary Completion Date :

Oct 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AAV-DC-CTL	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

Arm

Intervention/Treatment

Experimental: AAV-DC-CTL

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

Outcome Measures

Primary Outcome Measures

Objective response rate [Up to 12 months]
CR + PR = ORR

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin	China	300060

Sponsors and Collaborators

Tianjin Medical University Cancer Institute and Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tianjin Medical University Cancer Institute and Hospital

ClinicalTrials.gov Identifier:

NCT01637805

Other Study ID Numbers:

CIH-ZRP-201205001

First Posted:

Jul 11, 2012

Last Update Posted:

Mar 8, 2016

Last Verified:

Jul 1, 2012

Additional relevant MeSH terms:

Stomach Neoplasms

Study Results

No Results Posted as of Mar 8, 2016