A phase II continuous clinical trial of peptide vaccination for cancer patients

JRCT ID: jRCTs071180058

Registered date:19/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Malignant Tumor
• Date of first enrollment: 06/11/2008
• Target sample size: 200
• Countries of recruitment: No Country,Japan
• Study type: Interventional

Intervention(s)

Select vaccine peptides (up to 4) from 31 candidate peptides, to which peptide-specific IgGs are detected before vaccination.
Individually emulsify these peptides with adjuvant and subcutaneously inject (3.0mg/peptide).

Outcome(s)

• Primary Outcome: Analysis of correlation between peptide-specific antibody level and overall survival

Secondary Outcome

1) Analysis of correlation between CTL responses and overall survival
2) Evaluation of adverse events by CTCAE version 4.0 (JCOG)

Key inclusion & exclusion criteria

• Age minimum: above 6
• Age maximum: Not applicable
• Gender: Both

Include criteria

Following the acceptance criteria of the currently conducted 45 tests
Show a common reference to the following.
Common items are shown below
1) Patients must be more 6 years old
2) Patients must be at a score level 0 to 2 of ECOG perfformance status.
3) Written informed consent must be obtained from patients. Both the assent document and the written informed consent must be
obtained from a patient and his (her) parents or caregivers when a patient is with >=6 years to <20 years old.It is possible to obtained the written informed consent from either
the parents or an attorney if a patient is difficult to sign to it due to neurological or physical symptoms.

Exclude criteria

Exclusion criteria also follow exclusion criteria of 45 studies currently being conducted
1) Patients with severe symptoms(active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disease of coagulation)
2) Patients with the past history of severe allergic reactions.
3) (Females) Patienta who are during pregnancy, latation expectant and desiring future fertility.
(Males) Patients do not accept contraception during the last 70 days after the last vaccination.
4) Patient who are judged inappropriate for the clinical trial by doctors.

Related Information

• Primary Sponsor: Yutani Shigeru