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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by Yataro Daigo, Shiga University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01949688
First Posted: September 24, 2013
Last Update Posted: September 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tokyo University
Information provided by (Responsible Party):
Yataro Daigo, Shiga University
  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
Intervention Model: Parallel Assignment
Masking: None (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

Further study details as provided by Yataro Daigo, Shiga University:

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yataro Daigo, Professor, Shiga University
ClinicalTrials.gov Identifier: NCT01949688     History of Changes
Other Study ID Numbers: SUMS-22-15
22-15 ( Other Identifier: Shiga University )
First Submitted: September 20, 2013
First Posted: September 24, 2013
Last Update Posted: September 24, 2013
Last Verified: September 2013