Clinical trial NCT01949688: Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*24 or A*02-positive Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Solid Tumors
Lead sponsor: Shiga University
Sponsor class: OTHER
Collaborators: name: Tokyo University
First posted: 2013-09-24
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of safety: the number of adverse events of vaccination therapy.
timeFrame: 2 months
measure: Evaluation of clinical efficacy: Overall survival.
timeFrame: 2 months
Secondary outcomes:
measure: Various immunological responses including peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels.
timeFrame: 2 months
measure: Evaluation of clinical efficacy: Progression free survival.
timeFrame: 2 months
measure: Evaluation of clinical efficacy: Tumor markers.
timeFrame: 2 months
measure: Evaluation of clinical efficacy: Objective response rate.
timeFrame: 2 months
Other outcomes:
Locations:
city: Ohtsu
country: Japan
facility: Shiga University of Medical Science Hospital
state: Shiga
Study officials:
affiliation: Shiga University
name: Yataro Daigo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: