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Study of OTSGC-A24 Vaccine in Advanced Gastric Cancer

Primary Purpose

Gastric Cancer

Status

Unknown status

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

OTSGC-A24

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer vaccine, OTSGC-A24, A Phase I/IIa study, HLA-A24-positive

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must have histologically or cytologically confirmed inoperable or metastatic adenocarcinoma of the stomach or lower third of the oesophagus refractory or intolerable to standard therapy.
Patients must have measurable or evaluable disease.
Age >= 201years
ECOG performance status of 0 to 2
Life expectancy at least 3 months
Patients must have normal organ and marrow function as defined below:
absolute neutrophil count >=1,500/mcL
platelets >=100,000/mcL
total bilirubin within normal institutional limits
AST(SGOT)/ALT(SGPT) <=2.5 X institutional upper limit of
Normal creatinine within normal institutional limits
Patients must be HLA-A*2402
Patients must have recover from all reversible treatment toxicity from prior chemotherapy, radiotherapy or surgery.
The effects of OTSGC-A24 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients receiving any other investigational agents.
History of significant gastrointestinal bleeding that required intervention within the prior 1 month is ineligible; inherited bleeding diathesis or coagulopathy.
Serious non healing wound and peptic ulcer disease
Previous history of intestinal perforation
Invasive procedures defined as follows (Insertion of a vascular access device is not considered major/minor surgery):
Major surgical procedure, open biopsy or significant traumatic injury =28 days prior to -registration
Anticipation of need for major surgical procedures during the course of the study
Core biopsy <=7 days
Minor surgery <=2 weeks
Symptomatic CNS metastasis
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg), symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction/cerebrovascular event (<=6 months prior to study entry), cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, long term systemic immunosuppressant or corticosteroid.
Women who are breast-feeding or pregnant are excluded from this study

Sites / Locations

Wakayama Medical University Hospital
Severance Hospital, Yonsei University Health System
National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Weekly Cohort

2-weekly cohort

3-weekly cohort

Arm Description

The gastric cancer vaccine (OTSGC-A24) will be administered at a dose of 1 mg once a week

The gastric cancer vaccine (OTSGC-A24) will be administered at the dose of 1 mg every 2 weeks.

The gastric cancer vaccine (OTSGC-A24)will be administered at 1 mg very 3 weeks

Outcomes

Primary Outcome Measures

safety of OTSGC-24

Dose limiting toxicity will be evaluated during the first 4 weeks of treatment. If in the unlikely event that DLT is observed in 1 of the 3 subjects, an additional 3 subjects will be enrolled at the same dose level. If DLT is observed in 2 of the 6 subjects, subsequent cohorts will be treated at 0.5 mg.

Optimal dosing schedule

In each cohort, OTSGC-A24 (~1 mg) will be administered subcutaneously at 3-weekly (cohort 1), 2-weekly (cohort 2) and weekly (cohort 3) interval. Treatment may continue until the subject experiences confirmed disease progression or unacceptable toxicity, withdraws consent, or requires treatment with another therapeutic modality.

Secondary Outcome Measures

Induction of specific cytotoxic T-lymphocyte (CTL) response

Up to 10 patients per cohort will be recruited in the cohort or cohorts with the highest specific CTL induction rate to define the optimal dosing schedule for OTSGC-A24.

Full Information

NCT ID

NCT01227772

First Posted

October 21, 2010

Last Updated

June 21, 2016

Sponsor

National University Hospital, Singapore

Collaborators

Wakayama Medical University, Severance Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01227772

Brief Title

Study of OTSGC-A24 Vaccine in Advanced Gastric Cancer

Official Title

A Phase I/IIa Study of OTSGC-A24 Vaccine in Advanced Gastric Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2010 (undefined)

Primary Completion Date

November 2016 (Anticipated)

Study Completion Date

June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National University Hospital, Singapore

Collaborators

Wakayama Medical University, Severance Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Active vaccination with tumor specific antigens and VEGFR1 HLA-A24 epitopes can improve survival of patients with advanced Gastric Cancer.

Detailed Description

Although palliative chemotherapy improved the outcome of patients with advanced Gastric Cancer, the prognosis for this group of patients remains poor. Tumor specific antigens and angiogenesis pathway are potential targets for immunotherapy. A cocktail of peptide vaccines is selected to overcome gastric cancer's heterogeneous and enhance the anti-tumor effect. Five HLA-A*2402-binding peptide vaccines derived from tumor specific antigens and VEGFR1 are chosen based on the frequencies of their expressions in gastric cancer and the ability to induce specific cytotoxic T-lymphocytes. In preclinical model, both down regulation these targets with siRNA and active vaccination resulted in tumor regression. The purpose of the study is to evaluate the safety and optimal dosing schedule of a cancer vaccine cocktail, OTSGC-A24 targeting novel specific tumor antigens FOXM1, DEPDC1, KIF20A, URLC10 and VEGFR1 in advanced gastric cancer patients with HLA-2402 haplotype.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

gastric cancer vaccine, OTSGC-A24, A Phase I/IIa study, HLA-A24-positive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Weekly Cohort

Arm Type

Experimental

Arm Description

The gastric cancer vaccine (OTSGC-A24) will be administered at a dose of 1 mg once a week

Arm Title

2-weekly cohort

Arm Type

Experimental

Arm Description

The gastric cancer vaccine (OTSGC-A24) will be administered at the dose of 1 mg every 2 weeks.

Arm Title

3-weekly cohort

Arm Type

Experimental

Arm Description

The gastric cancer vaccine (OTSGC-A24)will be administered at 1 mg very 3 weeks

Intervention Type

Biological

Intervention Name(s)

OTSGC-A24

Intervention Description

OTSGC-A24 administered at 1 mg in weekly, 2-weekly, and 3-weekly cohorts.

Primary Outcome Measure Information:

Title

safety of OTSGC-24

Description

Time Frame

within 4 weeks of treatment

Title

Optimal dosing schedule

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Induction of specific cytotoxic T-lymphocyte (CTL) response

Description

Up to 10 patients per cohort will be recruited in the cohort or cohorts with the highest specific CTL induction rate to define the optimal dosing schedule for OTSGC-A24.

Time Frame

after 4 weeks and 12 weeks of vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must have histologically or cytologically confirmed inoperable or metastatic adenocarcinoma of the stomach or lower third of the oesophagus refractory or intolerable to standard therapy. Patients must have measurable or evaluable disease. Age >= 201years ECOG performance status of 0 to 2 Life expectancy at least 3 months Patients must have normal organ and marrow function as defined below: absolute neutrophil count >=1,500/mcL platelets >=100,000/mcL total bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT) <=2.5 X institutional upper limit of Normal creatinine within normal institutional limits Patients must be HLA-A*2402 Patients must have recover from all reversible treatment toxicity from prior chemotherapy, radiotherapy or surgery. The effects of OTSGC-A24 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Patients receiving any other investigational agents. History of significant gastrointestinal bleeding that required intervention within the prior 1 month is ineligible; inherited bleeding diathesis or coagulopathy. Serious non healing wound and peptic ulcer disease Previous history of intestinal perforation Invasive procedures defined as follows (Insertion of a vascular access device is not considered major/minor surgery): Major surgical procedure, open biopsy or significant traumatic injury =28 days prior to -registration Anticipation of need for major surgical procedures during the course of the study Core biopsy <=7 days Minor surgery <=2 weeks Symptomatic CNS metastasis Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg), symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction/cerebrovascular event (<=6 months prior to study entry), cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, long term systemic immunosuppressant or corticosteroid. Women who are breast-feeding or pregnant are excluded from this study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Peng Yong, MRCP, MB ChB

Organizational Affiliation

National University Hospital, Singapore

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wakayama Medical University Hospital

City

Wakayama

ZIP/Postal Code

641-8509

Country

Japan

Facility Name

Severance Hospital, Yonsei University Health System

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

National University Hospital

City

Singapore

Country

Singapore

12. IPD Sharing Statement

Citations:

PubMed Identifier

16368871

Citation

Ajani JA. Evolving chemotherapy for advanced gastric cancer. Oncologist. 2005;10 Suppl 3:49-58. doi: 10.1634/theoncologist.10-90003-49.

Results Reference

background

PubMed Identifier

16782930

Citation

Wagner AD, Grothe W, Haerting J, Kleber G, Grothey A, Fleig WE. Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data. J Clin Oncol. 2006 Jun 20;24(18):2903-9. doi: 10.1200/JCO.2005.05.0245.

Results Reference

background

PubMed Identifier

29587677

Citation

Sundar R, Rha SY, Yamaue H, Katsuda M, Kono K, Kim HS, Kim C, Mimura K, Kua LF, Yong WP. A phase I/Ib study of OTSGC-A24 combined peptide vaccine in advanced gastric cancer. BMC Cancer. 2018 Mar 27;18(1):332. doi: 10.1186/s12885-018-4234-8.

Results Reference

derived

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Study of OTSGC-A24 Vaccine in Advanced Gastric Cancer

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