Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*24 or A*02-positive Advanced Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumors
• Interventions: Biological: HLA-A*2402 or A*0201 restricted peptides

• Registration Number: NCT01949688
• Lead Sponsor: Shiga University

Brief Summary

In this study, the investigators examine using a combination of two types of HLA-A\*2402 (or HLA-A\*0201)-restricted epitope peptides, which were derived from VEGF-R1 and VEGF-R2 the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced solid tumor patients who are refractory to standard therapy.

Detailed Description

The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A\*2402 or HLA-A\*0201 restricted epitope peptides (VEGF-R1 and VEGF-R2) emulsified with Montanide ISA 51 for advanced solid tumors.

In this phase I/II trial, the investigators examine using a combination of the two peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A\*2402 or HLA-A\*0201-positive advanced solid tumor patients who are refractory to standard therapy.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2013-09-20
• Study First Submitted QC: 2013-09-20
• Study First Posted: 2013-09-24
• Status Verified: 2019-03
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Last Update Submitted: 2019-03-15
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Advanced solid tumors that are refractory to standard therapies or that cannot be treated with those due to medical reason.
2. ECOG performance status 0-1
3. Age between 20 to 85
4. Clinical efficacy can be evaluated by some methods
5. No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within two weeks
6. Life expectancy > 3 months
7. Laboratory values as follows 1500/mm3 < WBC < 10000/mm3 Platelet count > 75000/mm3 15% < Lymphcyte fraction Asparate transaminase < 3 X cutoff value Alanine transaminase < 3 X cutoff value Total bilirubin < 3 X cutoff value Serum creatinine < 2X cutoff value
8. HLA-A*2402 or HLA-A*0201
9. Able and willing to give valid written informed consent

Exclusion Criteria

1. Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia)
2. Myocardial infarction within six months before entry
3. Breastfeeding and Pregnancy (woman of child bearing potential)
4. Active and uncontrolled infectious disease
5. Concurrent treatment with steroids or immunosuppressing agent
6. Other malignancy requiring treatment
7. Non-cured traumatic wound
8. Decision of unsuitableness by principal investigator or physician-in-charge

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HLA-A*2402 restricted peptides	HLA-A*2402 or A*0201 restricted peptides	HLA-A\*2402 restricted peptides with adjuvant
HLA-A*0201 restricted peptides	HLA-A*2402 or A*0201 restricted peptides	HLA-A\*0201 restricted peptides with adjuvant

Primary Outcome Measures

Name	Time	Method
Evaluation of safety: the number of adverse events of vaccination therapy.	2 months
Evaluation of clinical efficacy: Overall survival.	2 months

Secondary Outcome Measures

Name	Time	Method
Various immunological responses including peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels.	2 months
Evaluation of clinical efficacy: Progression free survival.	2 months
Evaluation of clinical efficacy: Tumor markers.	2 months
Evaluation of clinical efficacy: Objective response rate.	2 months

Trial Locations

Locations (1)

Shiga University of Medical Science Hospital; 🇯🇵 Ohtsu, Shiga, Japan