Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Breast Cancer

• Sponsor: Tokyo University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00677326
• Collaborator: Human Genome Center, Institute of Medical Science, University of Tokyo (Other)
• Enrollment: 1
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and time to progression of HLA-A*0201 restricted epitope peptides VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in advanced breast cancer patients.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Biological: VEGFR1 and VEGFR2	Phase 1/Phase 2

Detailed Description

VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of the vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of these peptide vaccine. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Treating Patients With Refractory Breast Cancer
• Study Start Date: May 1, 2008
• Anticipated Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Peptide administered	Biological: VEGFR1 and VEGFR2; Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

Outcome Measures

Primary Outcome Measures

1. safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST) [2 months]

Secondary Outcome Measures

1. To evaluate immunological responses [2 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Advanced or recurrent breast cancer

• Resistant against anthracycline-based and taxane-based chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)

• Resistant against trastuzumab or difficult to continue it due to intolerable side effect(s) when her-2 is positive

• ECOG performance status 0-2

• Life expectancy > 3 months

• HLA-A*0201

• Laboratory values as follows

• 2000/mm3<WBC<15000/mm3

• Platelet count>100000/mm3

• Bilirubin < 3.0mg/dl

• Asparate transaminase < 150IU/L

• Alanine transaminase < 150IU/L

• Creatinine < 3.0mg/dl

• Able and willing to give valid written informed consent

Exclusion Criteria:

• Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)

• Breastfeeding

• Active or uncontrolled infection

• Unhealed external wound

• Concurrent treatment with steroids or immunosuppressing agent

• Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks

• Uncontrolled brain and/or intraspinal lesion(s)

• Decision of unsuitableness by principal investigator or physician-in-charge

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Institute of Medical Science, the University of Tokyo	Minato-ku	Tokyo	Japan	108-8639

Sponsors and Collaborators

• Tokyo University
• Human Genome Center, Institute of Medical Science, University of Tokyo

Investigators

• Study Chair: Naohide Yamashita, MD/PhD, Tokyo University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Research Hospital, the Institute of Medical Science, the University of Tokyo

Publications

• Ishizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9.
• Li Y, Wang MN, Li H, King KD, Bassi R, Sun H, Santiago A, Hooper AT, Bohlen P, Hicklin DJ. Active immunization against the vascular endothelial growth factor receptor flk1 inhibits tumor angiogenesis and metastasis. J Exp Med. 2002 Jun 17;195(12):1575-84. Erratum in: J Exp Med 2002 Aug 19;196(4):557.
• Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46.

• ClinicalTrials.gov Identifier: NCT00677326
• Other Study ID Numbers: Breast-A02-I, II
• First Posted: May 14, 2008
• Last Update Posted: Dec 29, 2009
• Last Verified: May 1, 2009

• Keywords provided by , ,: HLA-A*0201; Peptide Vaccine; VEGFR1; VEGFR2
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Dec 29, 2009