Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Active 20 to 85 Other CRC-A02-I, II NCT00677612

Trial Description

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 combination with Tegafur/Uracil/Folinate chemotherapy.

Further Study Information

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, clinical and immunological 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. The patients will also receive oral chemotherapy (Tegafur/Uracil/Folinate) simultaneously. Repeated cycles of the vaccine and the chemotherapy 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.

Eligibility Criteria

Inclusion Criteria:

• Advanced or recurrent colorectal cancer

• Resistant against chemotherapy including CPT-11, l-OHP、+/- 5-FU +/- bevacizumab or difficult to continue the chemotherapy due to intolerable side effect(s)

• 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 to receive oral Tegafur/Uracil/Folinate therapy

• 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)

• History of allergy to Tegafur, Uracil, and/or Folinate

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Tokyo Medical University

Masaru Shinozaki, MD/PhD

Principal Investigator

Masaru Shinozaki, MD/PhD		Ph: 81-3-3443-8111 Ext.72418
		Email: mshino@ims.u-tokyo.ac.jp

Japan
	Minato-ku
	University of Tokyo Hospital
		Masaru Shinozaki, MD/PhD	Ph: 81-3-3443-8111 Ext.72418
			Email: mshino@ims.u-tokyo.ac.jp
		Masaru Shinozaki, MD/PhD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00677612
Information obtained from ClinicalTrials.gov on July 16, 2008