Vaccine HER1 / VSSP for prostate cancer, head and neck carcinoma and advanced colon cancer . Phase I

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000258
• Date of registration: 03/11/2017
• Prospective Registration: Yes
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: Vaccine HER1 / VSSP for prostate cancer, head and neck carcinoma and advanced colon cancer . Phase I
• Scientific title: Phase I study with the HER1 / VSSP therapeutic vaccine in patients with hormone-castration-resistant prostate cancer, advanced squamous cell carcinoma of the head and neck and colon cancer
• Date of first enrolment: 15/11/2017
• Target sample size: 120
• Recruitment status: Pending
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000258-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Parallel. Purpose: Treatment
• Phase: 1

Countries of recruitment

Cuba

Contacts

• Name: Amparo Emilia Macias Abraham
• Affiliation: Center of Molecular Immunology

• Name: Amparo Emilia Macias Abraham
• Affiliation: Center of Molecular Immunology (CIM)

Key inclusion & exclusion criteria

Inclusion criteria: 1. Compliance with one of the defined diagnostic criteria.
2. Availability of the blocks to evaluate the expression, by immunohistochemical techniques, of R-EGF and biomarkers (such as K-ras, N-ras, B-raf, HPV and p16).
3. Patient giving written informed consent to participation.
4. Age over 18 years.
5. General condition according to ECOG = 2.
6. Life expectancy of at least 6 months.
7. Functioning of organs and bone marrow defined by the following parameters: Hemoglobin (Hb) = 10 g / dl, Total white blood cell count = 3 x 109 / L, 100 Platelet count (CP) = 100 x 109 / L , total bilirubin = 2.5 times the upper normal institutional limit, creatinine within normal limits for each institution.
Exclusion criteria: 1. Patients of childbearing potential who are not using a suitable method of contraception prior to their inclusion in the study (intrauterine devices, hormonal contraceptives, barrier methods or surgical sterilization).
2. Pregnant or breastfeeding.
3. Positive serology known to HIV, hepatitis B or C.
4. Acute allergic states or history of severe allergic reactions.
5. Acute or chronic decompensated lung diseases that may interfere with the follow-up of the underlying disease.
6. Previous history of demyelinating or inflammatory diseases of the central nervous system (CNS) or peripheral (PNS).
7. Uncontrolled intercurrent diseases including, but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, Diabetes Mellitus, and psychiatric diseases involving the incompetence of the subject.
8. Cerebral metastasis.
9. Known hypersensitivity to any component of the formulation.
10. Patients who are receiving another product under investigation.

Age minimum: 18 years
Age maximum: None
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Colonic Diseases

Colorectal Neoplasms

Digestive System Neoplasms

Genital Diseases, Male

Genital Neoplasms, Male

hormonal castration-resistant prostate cancer, squamous cell carcinoma of the head and neck, and advanced colon cancer

Neoplasms, Glandular and Epithelial

Neoplasms, Squamous Cell

Intestinal Diseases

Digestive System Diseases

Male Urogenital Diseases

Intestinal Neoplasms

Prostatic Neoplasms, Castration-Resistant

Carcinoma

Carcinoma, Squamous Cell

Gastrointestinal Neoplasms

Prostatic Neoplasms

Colonic Neoplasms

Head and Neck Neoplasms

Urogenital Neoplasms

Gastrointestinal Diseases

Prostatic Diseases

Intervention(s)

HER1/VSSP; therapeutic vaccine

Injections, Subcutaneous

Receptor, Epidermal Growth Factor

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.

Vaccines

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

Secondary Outcome(s)

Related to Immunogenicity:
1. Antibody response IgG against DEC-HER1 protein (Antibody titers by ELISA technique). Measurement time: Day 0, 56, 84, 112, 168, 196, 252 and 336.
2. Recognition of the A431 human vulvar tumor line by means of the FACS flow cytometer. Measurement time: Day 0, 56, 84, 112, 168, 196, 252 and 336.
3. Response of T cells producing IFN? by means of an ELISPOT technique. Measurement time: Day 0, 112, and 196.
Related to security:
1. Adverse Events-AE (Intensity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The CTCAE establishes the categories: Grade 1 Mild, Grade 2 Moderate, Grade 3, Grade 4 Life-threatening, Grade 5 Death related to EA; Causal relationship will be classified according to 45/2007 CECMED regulation and WHO categories. The categories are: Definitive, Very likely/safe, Probable, Possible, Unrelated and Unknown). Measurement time: Day 0, 14, 28, 42, 56, 84 112, 140, 168, 196, 224, 252, 280, 308, 336, and 364.
2. Results of laboratory tests (Hematologic: Hemoglobin (g/dL), Hematocrit (quantity x109/L), Quantity of total leukocytes (quantity x109/L), Neutrophil (%), Lymphocytes (%), Basophils (%), Eosinophils (%), Monocytes (%). Biochemistry: Creatinine (mmol/L), Alkaline Phosphatase (U/L), TGO (U/L), TGP (U/L), Glycemia (mmol/L), LDH, PSA (mmol/L). Urine: Hematuria (x104), Leucos (x104), Proteinuria (x104)). Measurement time: at baseline and every four weeks during the study. Only PSA will be given to patients with hormone-castration-resistant prostate cancer at months 3, 6, 9, and 12.
3. Vital signs (blood pressure (values in mmHg), heart rate (values in beats per minute), and temperature (values in degrees Celsius). Measurement time: at baseline and, every time in the immunization, days 0, 14, 28, 42, 56, 84, 112, 168, 196, 252 and 336.
4. Batch of HER1 (number of the batch used). Measurement time: in every immunization.
Related to effect
1. Objective response (Complete Response, Partial Response, Stable Disease according to RECIST criteria). Measurement time: 3, 6 and 9 months; and 4 weeks after the last immunization.
2. Progression-free survival (Time from randomization patient until the progression or the death). Measurement time: day: 0, 14, 28, 42, 56, 84 112, 140, 168, 196, 224, 252, 280, 308, 336, and 364.
3. Overall Survival (Time from randomization patient until the death). Measurement time: 24 months.

Secondary ID(s)

Not applicable

Source(s) of Monetary Support

State Reserve

Secondary Sponsor(s)

Not applicable