Gemcitabine With Peptide Vaccine Therapy in Treating Patients With Bile Duct Cancer

• Status: Suspended
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, and immune response of different doses of URLC10 peptide emulsified with Montanide ISA51 in combination with gemcitabine. Recommended phase II dose will be also determined.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akita University Hospital
• Collaborator: Human Genome Center, Institute of Medical Science, University of Tokyo
• Treatments: Gemcitabine; Vaccines

Criteria

Inclusion Criteria:

DISEASE CHARACTERISTICS

1. Advanced bile duct cancer precluding curative surgical resection and recurrent bile duct cancer

2. measurable disease by CT scan, ultrasonography, or other imaging modalities.

PATIENTS CHARACTERISTICS

1. ECOG performance status 0-2

2. Life expectancy >3 months

3. Laboratory values as follows 2,000/mm³< WBC < 15,000/mm³ Platelet count ≥ 75,000/mm³ Bilirubin ≤ 1.5 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

4. HLA-A*2402 or HLA-A*0201

5. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)

2. Breastfeeding

3. Serious or uncontrolled infection

4. Prior chemotherapy (except gemcitabine), radiation therapy, or immunotherapy within 4 weeks.

5. Other malignancy within 5 years prior to entry into the study

6. Concomitant treatment with steroids or immunosuppressing agent

7. Disease to the central nervous system

8. Decision of unsuitableness by principal investigator or physician-in-charge