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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Shiga University
Sponsor:
Collaborator:
Tokyo University
Information provided by (Responsible Party):
Yataro Daigo, Shiga University
ClinicalTrials.gov Identifier:
NCT01949688
First received: September 20, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Solid Tumors
Biological: HLA-A*2402 or A*0201 restricted peptides
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Shiga University:

Primary Outcome Measures:
  • Evaluation of safety: the number of adverse events of vaccination therapy. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Evaluation of clinical efficacy: Overall survival. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Various immunological responses including peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Evaluation of clinical efficacy: Progression free survival. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Evaluation of clinical efficacy: Tumor markers. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Evaluation of clinical efficacy: Objective response rate. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 26
Study Start Date: June 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HLA-A*2402 restricted peptides
HLA-A*2402 restricted peptides with adjuvant
Biological: HLA-A*2402 or A*0201 restricted peptides

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.
Experimental: HLA-A*0201 restricted peptides
HLA-A*0201 restricted peptides with adjuvant
Biological: HLA-A*2402 or A*0201 restricted peptides

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.

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

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01949688

Contacts
Contact: Yataro Daigo, MD, PhD 1-81-77-548-2111 ydaigo@belle.shiga-med.ac.jp

Locations
Japan
Shiga University of Medical Science Hospital Recruiting
Ohtsu, Shiga, Japan, 520-2192
Sponsors and Collaborators
Shiga University
Tokyo University
Investigators
Principal Investigator: Yataro Daigo, MD, PhD Shiga University
  More Information

No publications provided

Responsible Party: Yataro Daigo, Professor, Shiga University
ClinicalTrials.gov Identifier: NCT01949688     History of Changes
Other Study ID Numbers: SUMS-22-15, 22-15
Study First Received: September 20, 2013
Last Updated: September 20, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 23, 2014