EC122 HER-1 Prostate Phase I

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000219
• Date of registration: 15/11/2016
• Prospective Registration: No
• Primary sponsor: Center of Molecular Immunology
• Public title: EC122 HER-1 Prostate Phase I
• Scientific title: Phase I clinical trial of the HER-1 vaccine in patients with prostate tumors of epithelial origin. - EC FI HER-1 CPRC
• Date of first enrolment: 23/10/2009
• Target sample size: 25
• Recruitment status: Complete
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000219-En
• Study type: Interventional
• Study design: Allocation: Non-randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Other. Purpose: Treatment
• Phase: 1

Countries of recruitment

Cuba

Contacts

• Name: Angel Raimundo Casaco Parada
• Affiliation: Center of Molecular Immunology

• Name: Angel Raimundo Casaco Parada
• Affiliation: Center of Molecular Immunology

Key inclusion & exclusion criteria

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.

Age minimum: 40 years
Age maximum: None
Gender: Male

Health Condition(s) or Problem(s) studied

Prostatic Diseases

Prostatic Neoplasms

Genital Diseases, Male

Urogenital Neoplasms

Genital Neoplasms, Male

Hormone refractory prostate cancer

Urogenital Diseases, Male

Intervention(s)

Receptor, Epidermal Growth Factor

Injections, Intramuscular

Group I (Experimental): HER-1 dose 100 µg by intramuscular route. Patients will receive 9 immunizations in days 0, 14, 28, 42, 56, 84, 112, 140 y 168.
Group II (Experimental): HER-1 dose 200 µg by intramuscular route. Patients will receive 9 immunizations in days 0, 14, 28, 42, 56, 84, 112, 140 y 168.
Group III (Experimental): HER-1 dose 400 µg by intramuscular route. Patients will receive 9 immunizations in days 0, 14, 28, 42, 56, 84, 112, 140 y 168.
Group IV (Experimental): HER-1 dose 600 µg by intramuscular route. Patients will receive 9 immunizations in days 0, 14, 28, 42, 56, 84, 112, 140 y 168.
Group V (Experimental): HER-1 dose 800 µg by intramuscular route. Patients will receive 9 immunizations in days 0, 14, 28, 42, 56, 84, 112, 140 y 168

Immunization

HER-1

Vaccines

Primary Outcome(s)

Toxicity of the vaccine preparation with human HER-1
- 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:
- AE name (Description of the AE)
- AE intensity (Light, Moderate, Severe, Very severe, Death related to the adverse event)
- Causality relationship (Definitive, Very likely, Probable, Possible, Not related)
- Treatment applied (None, medication, surgical procedure, Transfusion, Others)
- Result of the treatment applied to counteract the EA (Recovered, Continue, Unknown, Death due to the adverse event)

Secondary Outcome(s)

Immunogenicity of the vaccine HER-1
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

Secondary ID(s)

EC122

Source(s) of Monetary Support

State reserve (government funds)

Secondary Sponsor(s)

Not applicable