Study of OTSGC-A24 Vaccine in Advanced Gastric Cancer

NCT01227772 | Unknown Phase 1

• 1 other identifier: GA04/26/10
• Study Type: interventional
• Target: 23
• Locations: 3 countries
• Sites: 3

Brief Summary

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

Conditions

Gastric Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  within 4 weeks of treatment

• 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.

  1 year

Secondary Outcomes (1)

• Induction of specific cytotoxic T-lymphocyte (CTL) response

  after 4 weeks and 12 weeks of vaccination

Study Arms (3)

Weekly Cohort

EXPERIMENTAL

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

Biological: OTSGC-A24

2-weekly cohort

EXPERIMENTAL

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

Biological: OTSGC-A24

3-weekly cohort

EXPERIMENTAL

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

Biological: OTSGC-A24

Interventions

OTSGC-A24 BIOLOGICAL

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

2-weekly cohort; 3-weekly cohort; Weekly Cohort

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Wakayama Medical University: collaborator
• Severance Hospital: collaborator

Study Sites (3)

Wakayama Medical University Hospital

Wakayama, 641-8509, Japan

Location

National University Hospital

Singapore, Singapore, Singapore

Location

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

Related Publications (3)

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

  PMID: 16368871 BACKGROUND

• 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.

  PMID: 16782930 BACKGROUND

• 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.

  PMID: 29587677 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Wei Peng Yong, MRCP, MB ChB

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: October 25, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2016
• Study Completion: June 1, 2017
• Last Updated: June 22, 2016

Record last verified: 2016-06

Locations

KR (1); JP (1); SG (1)