Racotumomab-alum cancer vaccine for solid tumors in pediatric patients

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:

Open, single-center,clinical trial with racotumomab-alum vaccine in pediatric patients diagnosed with neuroblastoma, Ewing sarcoma or nephroblastoma.

Secondary indentifying numbers:

Not apllicable

Issuing authority of the secondary identifying numbers:

Not apllicable

Source(s) of monetary or material support:

Center of Molecular immunology (CIM) Cuban Ministry of Public Health (MINSAP)

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:

Maria

Midle name:

Caridad

Last name:

Gonzalez Carrasco

Medical Specialty :

First degree Specialist in Pediatrics

Affiliation:

Juan Manuel Marquez Pediatric Hospital

Postal address:

31 Ave and 76, Marianao

City:

Havana

Country:

Cuba

Zip Code:

11500

Telephone:

+53-72606140

Email address:

mcglez@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:

Not applicable

Research ethics committees:

Juan Manuel Marquez Pediatric Hospital, February 12th, 2015

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

20/12/2015

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:

Neuroblastoma, Nephroblastoma, Ewing's Sarcoma

Health condition(s) code:

Neuroblastoma

Sarcoma, Ewing

Wilms Tumor

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors, Primitive

Neuroectodermal Tumors

Neoplasms, Neuroepithelial

Neoplasms, Glandular and Epithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Osteosarcoma

Sarcoma

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Health condition keyword:

pediatric solid tumors

Intervention(s):

Experimental group: Racotumomab-Alum vaccine. Dose of 0.5mg (0.5 ml) of vaccine by intradermal route, subdivided into two sub-doses of 0.25ml per injection site every 14 days for up to 5 doses of vaccine (induction phase) and then immunizations will be received every 28 days (maintenance phase) until to complete the year of treatment, while some stopping criterion not appear.

Intervention keyword:

Racotumomab-Alum 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):

Adverse events related to vaccine (AE with causality relationship: definitive, very probable, probable, and possible). Measuring time: in every administration of the vaccine

Key secondary outcomes:

Antibody titers against NGcGM3 (The inverse of the highest serum dilution giving optical density ≥ 0.25 and twice the value of the pre-immune serum). Measuring time: at baseline, 3, 6, 9 and 12 months of treatment. Ability to lyse ganglioside expressing cells (Percentage of dead cells ≥20 %, after subtracting the pre-immune to hyper-immune percent). Measuring time: at baseline, 3, 6, 9 and 12 months of treatment

Selection criterias

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

Gender:

Male/Female

Minimum age:

1 year

Maximum age:

18 years

Inclusion criteria:

1. Patients older than 1 year of age and under 19 years. 2. Patients who meet the diagnostic criteria. 3. Patients in which the period between the end of the last oncoespecifica therapy and study inclusion is not less than 30 nor more than 60 days. 4. Voluntary patient and / or family or guardian to participate in the study by signing the informed consent model. 5. Patients who are using contraceptive methods if sexually active 6. Patients with histologically confirmed tumors that express NeuGc-GM3 in tumor tissue. 7. General health as Karnofsky index (KPS) ≥ 50% (over 16 years), Lansky ≥ 50% (for those under 16 years) 8. Patients with a life expectancy ≥ 3 months 9. Laboratory parameters within normal limits defined as: - Hematology: Hemoglobin ≥ 100 g / L, absolute neutrophil count ≥ 1500 cells / L, platelets ≥ 100x109 / L - Liver function: Within normal limits defined by TGP, TGO ≤ 2.5 above the reference value - Renal function: Serum creatinine ≤ 1.5 above the reference value. ¿No es correcto? 1. Patients older than 1 year of age and under 19 years. 2. Patients who meet the diagnostic criteria. 3. Patients in which the period between the end of the last oncoespecifica therapy and study inclusion is not less than 30 nor more than 60 days. 4. Voluntary patient and / or family or guardian to participate in the study by signing the informed consent model. 5. Patients who are using contraceptive methods if sexually active 6. Patients with histologically confirmed tumors that express NeuGc-GM3 in tumor tissue. 7. General health as Karnofsky index (KPS) ≥ 50% (over 16 years), Lansky ≥ 50% (for those under 16 years). (Annex 2) 8. Patients with a life expectancy ≥ 3 months 9. Laboratory parameters within normal limits defined as: - Hematology: Hemoglobin ≥ 100 g / L, absolute neutrophil count ≥ 1500 cells / L, platelets ≥ 100x109 / L - Liver function: Within normal limits defined by TGP, TGO ≤ 2.5 above the reference value - Renal function: Serum creatinine ≤ 1.5 above the reference value

Exclusion criteria:

1. Patients participating in another clinical trial. 2. Patients who are pregnant or nursing 3. Patients with a history of encephalopathy, seizures or severe allergies. 4. Patients who at the time of inclusion present associated chronic diseases in decompensation stage. 5. Patients who present a history of hypersensitivity to the product or any component 6. Patients with febrile states, and / or severe septic processes. 7. Patients with immunosuppressive disease or HIV positive. 8. Patients who have been treated with specific immunotherapy in the 6 months prior to inclusion in the study.

Type of population:

Children

Type of participant:

Patients

Study design

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

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

Target sample size:

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:

Maurenis

Last Name:

Hernandez Perez

Specialty:

First degree specialist in Oncology

Affiliation:

Center of Molecular Immunology

Postal Address:

216 & 15 Ave, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+537-2717933 ext 3489

Email :

maurenis@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:

Maurenis

Last Name:

Hernandez Perez

Specialty:

First degree specialist in Oncology

Affiliation:

Center of Molecular Immunology

Postal Address:

126 & 15 Ave, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+537 2717933 ext 3489

Email :

maurenis@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:

RPCEC00000206

Date of Registration in Primary Registry:

15/12/2015

Record Verification Date:

2015/12/15

Next update date:

2016/12/15

Link to the spanish version:

Click here [3]