UMIN ID: UMIN000000905
Registered date:23/11/2007
Immunotherapy Using HLA-A24-restricted Survivin-derived Peptide Mixed with IFA, IFA and IFN-alpha, IFA and IL-2, or IFA and GM-CSF for Patients with Digestive Cancer and Endocrine Organic Cancer (Phase I clinical study)
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | Advanced or recurrent digestive cancer and Endocrine Organic Cancer |
| Date of first enrollment | 2004/02/01 |
| Target sample size | 108 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Vaccination of survivin-2B peptide mixed with IFA every 2 weeks Vaccination of survivin-2B peptide mixed with IFA every 2 weeks, and IFN-alpha twice a week Vaccination of survivin-2B peptide mixed with IFA every 2 weeks, and IL-2 twice a week Vaccination of survivin-2B peptide mixed with IFA every 2 weeks, and GM-CSF twice a week |
Outcome(s)
| Primary Outcome | Evaluation of adverse effect |
|---|---|
| Secondary Outcome | Evaluation of immunological and clinical responses. Immunological responses were investigated by DTH, tetramer staining, and ELISPOT assay. Clinical responses were evaluated by RECIST criteria and change of tumor marker levels. |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 85years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Exclusion criteria included (1) the presence of other cancers that might influence the prognosis, (2) immunodeficiency or a history of splenectomy, (3) need of steroid therapy, (4) severe cardiac insufficiency, acute infection, or hematopoietic failure, (5) prior cancer therapy such as chemotherapy, radiation therapy, steroid therapy, or other immunotherapy within the past 4 weeks, (6) ongoing breast-feeding, and (7) unsuitability for the trial based on clinical judgment. |
Related Information
| Primary Sponsor | Department of Surgery, Sapporo Medical University School of Medicine |
|---|---|
| Secondary Sponsor | Department of Pathology Sapporo Medical University, School of medicine |
| Source(s) of Monetary Support | Japan Science and Technology Corporation Innovation Plaza Hokkaido, Sapporo, Japan |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yuji Iwayama |
| Address | South-1, West-16, Chuo-ku, Sapporo, Japan Japan |
| Telephone | 011-611-2111(3281) |
| iwayama@sapmed.ac.jp | |
| Affiliation | Sapporo Medical University Department of Surgery |
| scientific contact | |
| Name | Yuji Iwayama |
| Address | South-1, West-16, Chuo-ku, Sapporo, Japan Japan |
| Telephone | 011-611-2111 |
| Affiliation | Sapporo Medical University Department of Surgery |