Immunotherapy of Gastric Cancer With Autologous Tumor Derived Heat Shock Protein gp96

Gastric Carcinoma Clinical Trial

Official title:

Immunotherapy of Gastric Cancer With Autologous Tumor Derived Heat Shock Protein gp96

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02317471
• Other study ID #: PLAG-CS-Ga-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: December 10, 2014
• Last updated: June 2, 2016
• Start date: November 2014
• Est. completion date: December 2017

Study information

• Verified date: June 2016
• Source: Chinese PLA General Hospital
• Contact: Zheng Peng, MD
• Phone: 086-10-66938028
• Email: zihpeng[@]sina.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of autologous gp96 treatment of gastric cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Disease characteristics: Histologically confirmed gastric carcinoma: clinical stage III (according to the Japanese gastric cancer classification), must have undergone radical resection

2. Able to read and understand the informed consent document, must sign the informed consent

3. Age: 18 to 75 years old

4. Availability of at least 0.5 g tumor sample

5. ECOG =1;life expectancy >=12 weeks, able to comply with study-related procedures

6. Adequate bone marrow function including the absence of lymphopenia (ANC > 1,500/ mm3; Hemoglobin > 10g/dL ; platelet count >100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase [AST], alanine amino transferase [ALT] <2.5 times institutional upper limit of normals [IULNs] and bilirubin (total) <1.5 times IULN), and adequate renal function (BUN and creatinine <1.5 times IULNs)

7. Normal heart function

8. NOT participate in ANY other clinical trials within 4 weeks prior to vaccination.

Exclusion Criteria:

1. Unable to get the informed consent

2. Female patients who are pregnant or breastfeeding

3. Progression prior to treatment as determined by the principal investigator

4. Transplant recipient

5. Patients currently diagnosed with Human Immunodeficiency Virus or other active uncontrolled infection

6. Unstable or severe intercurrent medical conditions

7. Patient with allergic constitution

8. Patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Carcinoma
• Stomach Neoplasms

Intervention

Biological:
• autologous gp96 vaccination
Vaccination of gp96 derived from autologous tumor tissue. Treatment will be started between 3-6 weeks after the surgery. gp96 of 25ug in 1mL normal saline s.c. on days 1 of each cycle, up to a maximum of 10 doses (1 cycle= 7 days). 200-400mg cyclophosphamide i.v. 1-3 days before each gp96 infusion.

Drug:
• Oxaliplatin+S-1
Treatment will be start at the 5th week after the surgery. S-1: 40~60mg bid,d1~14 q3W; oxaliplatin:130mg/m2,iv drip for 2h,d1,q3W 6 cycles.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Cure&Sure Biotech Co., LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival		2 years	No
Primary	Number of participants with adverse events related to gp96 immunotherapy	A complete blood count will be requested before the first vaccination, after the second vaccination and after the last vaccination to monitor the side effect of gp96 immunotherapy. And blood chemistries will also be requested at the same time point for the same reason.; And other adverse events related to gp96 immunotherapy will be recorded according to the NCI-CTCAE 3.0 criteria.	participants will be followed from the day of the first vaccination to the 30th day after the last vaccination.	Yes
Secondary	Changes in antigen specific T cells	Tumor antigen specific T cells will be determined by IFN-? Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen.	within 3 days before the first vaccination and within 3 days after the 10th vaccination	No
Secondary	Overall survival		3 years	No