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

NCT01949688 | Completed Phase 1 DMC

• 2 other identifiers: SUMS-22-1522-15
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Evaluation of safety: the number of adverse events of vaccination therapy.

  2 months

• Evaluation of clinical efficacy: Overall survival.

  2 months

Secondary Outcomes (4)

• 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

Study Arms (2)

HLA-A*2402 restricted peptides

EXPERIMENTAL

HLA-A\*2402 restricted peptides with adjuvant

Biological: HLA-A*2402 or A*0201 restricted peptides

HLA-A*0201 restricted peptides

EXPERIMENTAL

HLA-A\*0201 restricted peptides with adjuvant

Biological: HLA-A*2402 or A*0201 restricted peptides

Interventions

HLA-A*2402 or A*0201 restricted peptides BIOLOGICAL

Open Label, Non-Randomized, Safety/Efficacy study: 1. HLA-A\*2402-positive patients will be vaccinated subcutaneously once a week with HLA-A\*2402 restricted peptides for VEGF-R1 and VEGF-R2 with adjuvant. 2. HLA-A\*0201-positive patients will be vaccinated subcutaneously once a week with HLA-A\*0201 restricted peptides for VEGF-R1 and VEGF-R2 with adjuvant.

HLA-A*0201 restricted peptides; HLA-A*2402 restricted peptides

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced solid tumors that are refractory to standard therapies or that cannot be treated with those due to medical reason.
• ECOG performance status 0-1
• Age between 20 to 85
• Clinical efficacy can be evaluated by some methods
• No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within two weeks
• Life expectancy \> 3 months
• 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
• HLA-A\*2402 or HLA-A\*0201
• Able and willing to give valid written informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Shiga University: lead
• Tokyo University: collaborator

Study Sites (1)

Shiga University of Medical Science Hospital

Ohtsu, Shiga, 520-2192, Japan

Location

MeSH Terms

Interventions

HLA-A*24:02 antigen

Study Officials

• Yataro Daigo, MD, PhD

  Shiga University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2013
• First Posted: September 24, 2013
• Study Start: June 1, 2010
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

JP (1)