A phase II randomized clinical trial of personalized peptide vaccination in combination with Japanese herbal medicines for castration-resistant prostate cancer (CRPC)

INTERVENTION: A: Personalized peptide vaccination with oral herbal medicines treatment. Select peptide candidates (up to 4), to which peptide‐specific IgGs are detected before vaccination, and administer peptides (maximum 4) that showed the highest reactivity. Emulate these peptides individually and subcutaneously inject them separately (3.0 mg/1.5‐3.0 ml/peptide) every 1 week interval. Start oral use of hochuekkito (7.5g/day, 3X, 50 days) and keishibukuryougan (7.5g/dau, 3X, 50 days) on the same day with peptide vaccination. 1st treatment: total 8 times, every weeks) If the patients want to continue the vaccination after completion of the first cycle of 6 vaccinations, the peptide vaccination will be allowed to continue (every 2‐4 weeks) until unacceptable toxicity or withdrawal of consent. B: Personalized peptide vaccine alone Select peptide candidates (up to 4), to which peptide‐specific IgGs are detected before vaccination, and administer peptides (maximum 4) that showed the highest reactivity. Emulate these peptides individually and subcutaneously inject them separately (3.0 mg/1.5‐3.0 ml/peptide) every 1 week interval. If the patients want to continue the vaccination after completion of the first cycle of 6 vaccinations, the peptide vaccination will be allowed to continue (every 2‐4 weeks) until unacceptable toxicity or withdrawal of consent. CONDITION: Castration‐resistant prostate cancer PRIMARY OUTCOME: Comparison of immune‐enhancing effects between two groups. SECONDARY OUTCOME: 1. Comparison of peptide‐specific CTL responses in PBMCs between two groups. ; 2. Comparison of safety between two groups. ; 3. Comparison of overall survival between two groups . INCLUSION CRITERIA: The subjects must satisfy the following conditions. 1) Patients must be diagnosed as prostate cancer pathologically at the initial treatment. The patients must be suffering from castration‐resistant prostate cancer after standard treatment. 2) Patients must be at a score level of 0‐1 of performance status (PS) (ECOG). 3) Patients must be positive for HLA‐A2, HLA‐A24, HLA‐A26 or HLA‐A3 super type. 4) Patients must have IgG reactive to at least two of peptide the candidate peptides restricted to the patient's HLA types. 5) If patients have used previously hochuekkito and/or keishibukuryougan, patients must wait a treatment for 4 weeks. 6) Patients must be expected to survive more than 3 months. 7) Patients must satisfy the followings: WBC >and= 2,500/mm3 Lymphocyte >and=1,000/mm3 Hb >and= 8.0g/dl Platelet >and= 100,000/mm3 Serum Creatinine

Epistemonikos ID: 1d1184b66eb97518102aa75cb48bacad30b99205
First added on: Aug 22, 2024