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

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

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

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

State Reserve

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Iraida

Last name:

Caballero Aguirrechu

Medical Specialty :

2nd Degree Specialist in Oncology

Affiliation:

Hermanos Ameijeiras Hospital

Postal address:

San Lazaro No. 701 corner to Belascoain

City:

Havana

País:

Cuba

Zip Code:

10300

Telephone:

+53-78761434

Email address:

iraida.caballero@infomed.sld.cu [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, National Institute of Oncology and Radiobiology, Braulio Fernandez Mestre, MD. 1 st degree in Oncology.

Research ethics committees:

Hermanos Ameijeiras Hospital, March 17, 2017

National Institute of Oncology and Radiobiology, February 13, 2017

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

15/11/2017

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

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

Health condition(s) code:

Prostatic Neoplasms, Castration-Resistant

Colonic Neoplasms

Head and Neck Neoplasms

Carcinoma, Squamous Cell

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Prostatic Diseases

Genital Diseases, Male

Male Urogenital Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Intestinal Diseases

Gastrointestinal Diseases

Digestive System Diseases

Carcinoma

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Intervention(s):

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.

Intervention code:

Receptor, Epidermal Growth Factor

Vaccines

Injections, Subcutaneous

Intervention keyword:

HER1/VSSP; therapeutic vaccine

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

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

Key secondary outcomes:

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 IFNγ 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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Parallel

Phase:

Target sample size:

120

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Amparo

Middle Name:

Emilia

Last Name:

Macias Abraham

Specialty:

Specialist of Second degree in Clinical Biochemistry

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216 and 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+537-2717933 ext 3490

Email :

amparo@cim.sld.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Amparo

Middle Name:

Emilia

Last Name:

Macias Abraham

Specialty:

Specialist of Second degree in Clinical Biochemistry

Affiliation:

Center of Molecular Immunology

Postal Address:

216 and 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+53-72717933 ext 3490

Email :

amparo@cim.sld.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000258

Date of Registration in Primary Registry:

03/11/2017

Record Verification Date:

2017/11/03

Next update date:

2018/11/03

Link to the spanish version:

Click here [3]