Study of OTSGC-A24 Vaccine in Advanced Gastric Cancer

June 21, 2016 updated by: National University Hospital, Singapore

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

23

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Wakayama, Japan, 641-8509
        • Wakayama Medical University Hospital
  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital, Yonsei University Health System
  • Singapore
      • Singapore, Singapore
        • National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Weekly Cohort
The gastric cancer vaccine (OTSGC-A24) will be administered at a dose of 1 mg once a week
Biological: OTSGC-A24
OTSGC-A24 administered at 1 mg in weekly, 2-weekly, and 3-weekly cohorts.
EXPERIMENTAL: 2-weekly cohort
The gastric cancer vaccine (OTSGC-A24) will be administered at the dose of 1 mg every 2 weeks.
Biological: OTSGC-A24
OTSGC-A24 administered at 1 mg in weekly, 2-weekly, and 3-weekly cohorts.
EXPERIMENTAL: 3-weekly cohort
The gastric cancer vaccine (OTSGC-A24)will be administered at 1 mg very 3 weeks
Biological: OTSGC-A24
OTSGC-A24 administered at 1 mg in weekly, 2-weekly, and 3-weekly cohorts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety of OTSGC-24
Time Frame: within 4 weeks of treatment
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.
within 4 weeks of treatment
Optimal dosing schedule
Time Frame: 1 year
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Induction of specific cytotoxic T-lymphocyte (CTL) response
Time Frame: after 4 weeks and 12 weeks of vaccination
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.
after 4 weeks and 12 weeks of vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Collaborators

Severance Hospital
Wakayama Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ANTICIPATED)

November 1, 2016

Study Completion (ANTICIPATED)

June 1, 2017

Study Registration Dates

First Submitted

October 21, 2010

First Submitted That Met QC Criteria

October 21, 2010

First Posted (ESTIMATE)

October 25, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 22, 2016

Last Update Submitted That Met QC Criteria

June 21, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA04/26/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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