Study of OTSGC-A24 Vaccine in Advanced Gastric Cancer

NCT ID: NCT01227772

Last Updated: 2016-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2017-06-30

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Weekly Cohort

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

Group Type: EXPERIMENTAL

OTSGC-A24

Intervention Type: BIOLOGICAL

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

2-weekly cohort

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

Group Type: EXPERIMENTAL

OTSGC-A24

Intervention Type: BIOLOGICAL

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

3-weekly cohort

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

Group Type: EXPERIMENTAL

OTSGC-A24

Intervention Type: BIOLOGICAL

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

Interventions

OTSGC-A24

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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wakayama Medical University

OTHER

Sponsor Role: collaborator

Severance Hospital

OTHER

Sponsor Role: collaborator

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Peng Yong, MRCP, MB ChB

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

Wakayama Medical University Hospital

Wakayama, , Japan

National University Hospital

Singapore, Singapore, Singapore

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Countries

Japan; Singapore; South Korea

References

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

Reference Type: BACKGROUND

PMID: 16368871 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16782930 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29587677 (View on PubMed)

Other Identifiers

GA04/26/10

Identifier Type: -

Identifier Source: org_study_id