Status:
UNKNOWN
Study of OTSGC-A24 Vaccine in Advanced Gastric Cancer
Lead Sponsor:
National University Hospital, Singapore
Collaborating Sponsors:
Wakayama Medical University
Severance Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
21-99 years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2017
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01227772
Start Date
November 1 2010
End Date
June 1 2017
Last Update
June 22 2016
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Wakayama Medical University Hospital
Wakayama, Japan, 641-8509
2
National University Hospital
Singapore, Singapore, Singapore
3
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 120-752