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

Solid Tumors Clinical Trial

Official title:

Phase I/II Study Using Epitope Peptide Restricted to HLA-A*24 or HLA-A*02 in Patients With Advanced Solid Tumors That Are Refractory to Standard Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949688
• Other study ID #: SUMS-22-15
• Secondary ID: 22-15
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 2010
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: Shiga University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Biological:
• HLA-A*2402 or A*0201 restricted peptides
Open Label, Non-Randomized, Safety/Efficacy study: 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. 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.

Locations

Country	Name	City	State
Japan	Shiga University of Medical Science Hospital	Ohtsu	Shiga

Sponsors (2)

Lead Sponsor	Collaborator
Shiga University	Tokyo University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of safety: the number of adverse events of vaccination therapy.		2 months
Primary	Evaluation of clinical efficacy: Overall survival.		2 months
Secondary	Various immunological responses including peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels.		2 months
Secondary	Evaluation of clinical efficacy: Progression free survival.		2 months
Secondary	Evaluation of clinical efficacy: Tumor markers.		2 months
Secondary	Evaluation of clinical efficacy: Objective response rate.		2 months