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Gastric CancerPhase 1/2NCT01227772

Study of OTSGC-A24 Vaccine in Advanced Gastric Cancer

A Phase 1/2 study testing OTSGC-A24 in people with Gastric Cancer, run by National University Hospital, Singapore at 3 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 21 to 99 years
Conditions the study is for
Gastric Cancer
What is being tested?
OTSGC-A24
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
3 sitesin 3 countries
Study dates
Nov 2010to Jun 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 15Show fewer
  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Japan1 site

  • Wakayama Medical University Hospital

    Wakayama, 641-8509

Other trials in Japan

Singapore1 site

  • National University Hospital

    Singapore, Singapore

Other trials in Singapore

South Korea1 site

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752

Other trials in South Korea

About this study

Official title: 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.

Read the 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
Being tested
OTSGC-A24
Keywords
gastric cancer vaccine, OTSGC-A24, A Phase I/IIa study, HLA-A24-positive
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OTSGC-A24Biological

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

Study groups in NCT01227772
Study groupRoleWhat they receive
Weekly CohortExperimentalThe gastric cancer vaccine (OTSGC-A24) will be administered at a dose of 1 mg once a week
Receives: Biological: OTSGC-A24
2-weekly cohortExperimentalThe gastric cancer vaccine (OTSGC-A24) will be administered at the dose of 1 mg every 2 weeks.
Receives: Biological: OTSGC-A24
3-weekly cohortExperimentalThe gastric cancer vaccine (OTSGC-A24)will be administered at 1 mg very 3 weeks
Receives: Biological: OTSGC-A24

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: within 4 weeks of treatment

  2. 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.

    Measured: 1 year

Secondary outcomes (1)

  1. 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.

    Measured: after 4 weeks and 12 weeks of vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionNov 2016 (estimated)
  4. Study completionJun 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01227772
Sponsor's protocol ID
GA04/26/10
Status last verified
Jun 2016
First submitted
21 Oct 2010
Last updated
22 Jun 2016
Results posted
No
Data monitoring committee
No

Publications

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

    PubMed 16368871

  • 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.

    PubMed 16782930

  • 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.

    PubMed 29587677

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing OTSGC-A24 in people with Gastric Cancer, run by National University Hospital, Singapore at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan, Singapore, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

safety of OTSGC-24 (time frame: within 4 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01227772, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2016; AzTrials last refreshed its copy on 8 Nov 2026.

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