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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)

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) - Phase I Clinical Study of Peptide Vaccine Therapy Using Survivin-2B peptide mixed with adjuvant

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000905
Enrollment
108
Registered
2007-11-23
Start date
2004-02-01
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

Advanced or recurrent digestive cancer and Endocrine Organic Cancer

Interventions

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 wi

Sponsors

Department of Surgery, Sapporo Medical University School of Medicine
Lead Sponsor
Department of Pathology Sapporo Medical University, School of medicine
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients enrolled in this study were required to conform to the following criteria: (1) to have histologically confirmed digestive cancer and endocrine organic cancer, (2) to be HLA-A*2402 positive, (3) to be survivin-positive in the carcinomatous lesions by immunohistochemistry, (4) to be between 20 and 85 years old, (5) to be unresectable advanced cancer or recurrent cancer, (6) to have Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Evaluation of adverse effect

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactYuji Iwayama

Sapporo Medical University Department of Surgery

iwayama@sapmed.ac.jp011-611-2111(3281)

Outcome results

None listed

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