UMIN ID: UMIN000000619
Registered date:01/03/2007
Phase I clinical trial of pan-HLA type personalized peptide vaccine for advanced cancer patients
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Advanced cancer patients who are refractory to standard therapies for cancer |
| Date of first enrollment | 2007/03/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Peptides (maximum 4) among 24 (each 8 for HLA-A2, -A24, and -A3 super type) peptides, which were identified as vaccine candidates for cancer patients, are administered with Freund incomplete adjuvant. Vaccine peptide selection for each patient will be performed according to the reactivity of pre-vaccination plasma IgG to the candidate peptides. Each emulsified peptide (3 mg/peptide) are separately injected into subcutaneous once a week for 6-weeks (total 6 times). Chest X-ray and/or CT/MRI, and blood samples for hematology and biochemistry are taken at beginning and 1-week after the 6th vaccination. |
Outcome(s)
| Primary Outcome | Adverse events of peptide vaccine are evaluated based on the CTCAE v3.0 (JCOG version). |
|---|---|
| Secondary Outcome | Evaluation of immunological responses (cytotoxic T-lymphocytes , anti-peptide IgG) before and after vaccination. |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | The following patients must be excluded: 1) Patients are negative for HLA-A2, -A3, -A11, -A24, -A31, and -A33. 2) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation etc). 3) Patients with the past history of severe allergic reactions. 4) Pregnant, nursing, or who wants pregnancy. Patients with no acceptance of use effective contraception during and for at least 70 days after study participation. 5) Patients who are judged inappropriate for the clinical trial by doctors. |
Related Information
| Primary Sponsor | Department of Immunology, Kurume University School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | The Ministry of Education, Culture, Sports, Science, and Technology, Japan,The Ministry of Health, Labor and Welfare, Japan |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Akira Yamada |
| Address | Asahi-machi 67, Kurume,Fukuoka 830-0011, Japan Japan |
| Telephone | 0942-31-7744 |
| akiymd@med.kurume-u.ac.jp | |
| Affiliation | Kurume University Research Center for Innovative Cancer Therapy, Cancer Vaccine Department Division |
| scientific contact | |
| Name | Masanori Noguchi |
| Address | Asahi-machi 67, Kurume,Fukuoka 830-0011, Japan Japan |
| Telephone | 0942-31-7572 |
| Affiliation | Kurume University School of Medicine Department of Urology |