A Study With Peptide Vaccination in Treating Patients With Esophageal Cancer

University of Yamanashi

Status and phase: Unknown; Phase 2

Conditions: Esophageal Cancer

Treatments: Biological: peptide

Study type: Interventional

Funder types: Other

Identifiers

NCT00995358

YMU-02

Details and patient eligibility

About

The purpose of this study is to evaluate overall survival and immunological monitoring for peptide vaccination therapy using novel cancer testis antigens for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).

Full description

The phase I vaccination study using peptides derived from TTK, LY6K, and IMP-3 for locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who had failed for the standard therapy indicated that the vaccine treatment were well tolerated and feasible, and that antigen-specific T cell responses were strongly induced by the vaccination with some objective clinical responses. Thus, we are currently initiating the randomized phase II clinical vaccination study for the same cohort with ESCC to evaluate the survival benefit of the cancer vaccination.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

DISEASE CHARACTERISTICS

• Locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy

PATIENTS CHARACTERISTICS

• ECOG performance status 0-2
• Age≧ 20≦ 80years
• WBC≥ 2,000/mm³ Platelet count ≥ 75,000/mm³ Total bilirubin ≤ 2.0 x the institutional normal upper limits AST, ALT, ALP ≤ 2.5 x the institutional normal upper limits Creatinine ≤ 1.5 x the institutional normal upper limits
• No therapy 4 weeks prior to the initiation of the trial
• Able and willing to give valid written informed consent

Exclusion criteria

• Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
• Breastfeeding
• Serious bleeding disorder
• Serious infections requiring antibiotics
• Concomitant treatment with steroids or immunosuppressing agent
• Decision of unsuitableness by principal investigator or physician-in-charge

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

vaccination

Experimental group

Treatment:

Biological: peptide