Phase II clinical trial of personalized peptide vaccination for sarcoma patients

Phase II clinical trial of personalized peptide vaccination for sarcoma patients - Peptide vaccination for sarcoma patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003060

Enrollment

100

Registered

2010-01-19

Start date

2010-01-01

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

Sarcoma

Interventions

&lt

1st treatment: total 8 times, which include weekly injection for 4 times followed by bi-weekly injection for 4 times&gt

Select vaccine peptides (up to 4) from 31 candidate peptides , to which peptide-specific IgGs are detected before vaccination. Individually emulsify these peptides with IFA and subcutaneously inject (

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects must be satisfactory the following conditions. 1) patients must be diagnosed as sarcoma. Presence of target legion, former treatment, and disease stage are not considered. 2) patients must be at a score level 0-1 of ECOG performance status. 3) patients must have IgGs reactive to at least two of candidate peptides belongs to an apropriate group(s) for patient's HLA types. 4) patients must be expected to survive more than 3 months. 5) Patients must satisfy the followings. WBC is more than 2500 per mm3 Lymphocyte is more than 900 per mm3 Hb is more than 8.0 g per dL Platelet is more than 80000 per mm3 Serum creatinine is less than 2 times upper limit of normal. Total bilirubin is less than 2 times upper limit of normal. (for constitutional jaundice, 2.5 times less or equal) 6) patients must be more than 18 years old. 7) written informed consent must be obtained from patients. 8) patients must be positive for HLA-A2, A24, A26, A3, A11, A31 or A33.

Exclusion criteria

Exclusion criteria: The following patients must be excluded. 1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation). 2) Patients with the past history of severe allergic reactions. "3) (Females) Patients who are during pregnancy, lactation expectant, and desiring future fertility. (Males) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination. 4) Patients who are judged inappropriate for the clinical trial by doctors.

Design outcomes

Primary

Measure	Time frame
Evaluation of immune responses (anti-peptide IgG) before and after personalized peptide vaccination.	—

Secondary

Measure	Time frame
1. Evaluation of long-term prognosis (progression free survival and overall survival). 2. Adverse events of personalized peptide vaccination. Adverse events are evaluated by the NCI-CTCAE.	—

Countries

Japan

Contacts

Public ContactAkira Yamada

Kurume University Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division

akiymd@med.kurume-u.ac.jp0942-31-7744

Outcome results

None listed

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