EC122 HER-1 Prostate Phase I

Phase 1

Conditions: Hormone refractory prostate cancer
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Urogenital Diseases, Male
Prostatic Diseases

Registration Number: RPCEC00000219

Lead Sponsor: Center of Molecular Immunology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Male

Target Recruitment: 25

Inclusion Criteria

1. Patients who meet the diagnostic criteria.
2. Patients with greater than or equal to 40 years age.
3. Patients who have signed informed consent.
4. Patients with overall as less than 2 ECOG.
5. Patients with longer life expectancy of 6 months.
6. Patients with functioning of organs and bone marrow, defined by the following parameters:
- Hemoglobin greater than or equal to 90 g / l
- White blood cell count, greater than or equal to 3.0 x 109 leucocytes / L
- Absolute Neutrophil Count, greater than or equal to 1.5 x Neutrophil 109 / L
- Platelets greater than or equal to 100 x 109 platelets / L
- Bilirubin values within normal limits of the institution. (0 to 17 micromol / L).
- TGO/TGP less than or equal to 2.5 times the upper limit of the normal range in the institution.
- Creatinine values within normal limits of the institution. (35-135 micromol / L)

Exclusion Criteria

1.Patients receiving other onco-specific investigational product.
2.Patients with uncontrolled intercurrent illness including: active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, liver damage and psychiatric illness that may limit adherence to clinical trial requirements.
3. Patients with brain metastases.
4. Patients with compromised immune systems, including current disease or history of eczema, atopic dermatitis, autoimmune disease (autoimmune neutropenia, thrombocytopenia, hemolytic anemia, HIV, lupus erythematosus, Sjogen syndrome, scleroderma, myasthenia gravis Goodpasture syndrome, Addison's disease, Hashimoto's thyroiditis, Graves' disease).
5. Allergic patient to any component of the formulation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Toxicity of the vaccine preparation with human HER-1 <br> - Adverse Events (AE) measured at days 0, 56, 84, 112, 140, 168, 196, 224, 252, 280, 308 and 336. The AE will be measured as:<br> - AE name (Description of the AE)<br> - AE intensity (Light, Moderate, Severe, Very severe, Death related to the adverse event)<br> - Causality relationship (Definitive, Very likely, Probable, Possible, Not related)<br> - Treatment applied (None, medication, surgical procedure, Transfusion, Others)<br> - Result of the treatment applied to counteract the EA (Recovered, Continue, Unknown, Death due to the adverse event)

Secondary Outcome Measures

Name	Time	Method
Immunogenicity of the vaccine HER-1 <br>Antibody titer (concentration of polyclonal anti-HER-1 in the blood). Measuring time: 0, 56, 84, 112, 140, 168, 196, 224, 252, 280 and 308 days