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Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Non-Small-Cell Lung Cancer to Chemotherapy.

Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Non-Small-Cell Lung Cancer to Chemotherapy. - Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Non-Small-Cell Lung Cancer to Chemotherapy.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002141
Enrollment
9
Registered
2009-07-01
Start date
2009-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small-Cell Lung Cancer

Interventions

Both URLC10 and CDCA1 peptides restricted to HLA-A*2402 (0.5mg for each) are administered four times once a week. Both URLC10 and CDCA1 peptides restricted to HLA-A*2402 (1.0mg for each) are administe

Sponsors

Department of Respiratory Medicine, Juntendo University School of Medicine
Lead Sponsor
Human Genome Center, Institute of Medical Science, University of Tokyo
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Histologically and/or cytologically proven NSCLC, which is refractory to any chemotherapy. 2.ECOG performance status 0-2 3.No severe postoperative complications 4.Age between 20 to 80 5.3000/mm3<WBC<15000/mm3 Hemoglobin>8.0g/dl Platelet count>75000/mm3 Asparate transaminase < 150IU/L Alanine transaminase < 150IU/L Total bilirubin < 3.0mg/dl PaO2 > 60 torr Serum creatinine < 2.0mg/dl 6.Life expectancy > 3 months 7.HLA-A*2402 8.Able and willing to give valid written informed consent

Exclusion criteria

Exclusion criteria: 1.Pregnancy 2.Breastfeeding 3.Concurrent treatment with steroids or immunosuppressing agent 4.No other malignancy requiring treatment 5.No curative traumatic wound 6.Decision of unsuitableness by principal investigator or physician-in-charge

Design outcomes

Primary

MeasureTime frame
Evaluation of safety and adverse effects of vaccination therapy and determination of the recommended dose for phase II trial

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026