Vaccine HER1 / VSSP for prostate cancer, head and neck carcinoma and advanced colon cancer . Phase I
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ABSTRACT: Interventions: Group HER1/VSSP. Dose level 400 µg (experimental): The vaccine will be administered by subcutaneous route, the first 5 doses every 15 days (induction stage) and then the remaining 10 doses every 28 days until one year of treatment (maintenance stage).
Group HER1/VSSP. Dose level 800 µg (experimental): The vaccine will be administered by subcutaneous route, the first 5 doses every 15 days (induction stage) and then the remaining 10 doses every 28 days until one year of treatment (maintenance stage).
In each dose level will be recruited up to a maximum of 20 patients per 3 location (20 patients per dose level) for a maximum of 120 patients.
;Receptor, Epidermal Growth Factor;Vaccines;Injections, Subcutaneous;HER1/VSSP; therapeutic vaccine
Primary outcome(s): Proportion of patients with serious adverse events with causal relationship (EAS with definite / highly probable or probable causality with HER1 vaccine). Time of measurement: 0, 14, 28, 42, 56, 84 112, 140, 168, 196, 224, 252, 280, 308, 336, and 364 days
Study Design: Allocation: Randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Parallel. Purpose: Treatment
DISEASE(S): Neoplasms, Glandular And Epithelial,Gastrointestinal Neoplasms,Carcinoma,Intestinal Diseases,Digestive System Diseases,Head And Neck Neoplasms,Genital Neoplasms, Male,Neoplasms, Squamous Cell,Carcinoma, Squamous Cell,Gastrointestinal Diseases,Prostatic Neoplasms,Hormonal Castration-resistant Prostate Cancer, Squamous Cell Carcinoma Of The Head And Neck, And Advanced Colon Cancer,Prostatic Diseases,Male Urogenital Diseases,Genital Diseases, Male,Colorectal Neoplasms,Urogenital Neoplasms,Prostatic Neoplasms, Castration-resistant,Intestinal Neoplasms,Digestive System Neoplasms,Colonic Diseases,Colonic Neoplasms
PROVIDER: 2571600 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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