previously treated advanced non-small-cell lung cancer
Conditions
Interventions
Vacctination therapy of CDCA1 and KOC1
Sponsors
Showa University School of Medicine
Institute of Medical Science, University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with NSCLC who had previously received cytotoxic chemotherapy and who had been resistant to standard therapy were enrolled. The criteria for study entry were as follows: 1) histologically or cytologically confirmed NSCLC; 2) stage III or IV disease; 3) age 20 years or older; 4) Eastern Cooperative Oncology Group PS of 3 or less; 5) measurable or assessable lesions; 6) HLA-A*2402 positive; 7) life expectancy of at least 2 months; 8) adequate bone marrow function (neutrophil count of 1500/µl or more, platelet count of 75,000/µl or more, and hemoglobin level of 8 g/dl or more), hepatic function (total serum bilirubin level less than 2 mg/dl, levels of aspartate aminotransferase and alanine aminotransferase less than or equal to three times the upper limits of the normal ranges), and renal function (serum creatinine level less than 2 mg/dl).
Exclusion criteria
Exclusion criteria: Patients were excluded if they have already received vaccination therapy, they had severe heart disease, active infection, severe drug allergy, other serious underlying medical conditions, symptomatic brain metastasis, or an active second malignancy, and they received steroids or immunosuppressing agent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety, maximum tolerated dose, and recommended dose in phase I. To assess the progression-free survival in phase II. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the response rates, QOL, and the immunological responses in phase I. To assess the response rates, the safety, overall survival, QOL, and the immunological responses in phase II. | — |
Countries
Japan
Contacts
Public ContactTakashi Hirose
Showa University School of Medicine Division of Respiratory Medicine and Allergology, Department of Internal Medicine
Outcome results
None listed