99mTc-marked 14F7 MaB in metastatic breast, phase II

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:

Immuno gamma scanning with 99mTc-marked 14F7 MaB in patients with metastatic breast tumor

Secondary indentifying numbers:

IIC RD-EC073

Issuing authority of the secondary identifying numbers:

Center of Molecular Inmunology (CIM)

Source(s) of monetary or material support:

Government funds

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 the Quality of Drugs(CECMED)

Authorization date :

05/01/2005

Reference number:

094/05.026.04B

Principal investigator

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

First name:

Juan

Midle name:

Perfecto

Last name:

Oliva Gonzalez

Medical Specialty :

2nd degree specialist in oncology

Affiliation:

National Institute of Oncology and Radiobiology (INOR)

Postal address:

29 Street, corner F, Plaza

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78382578

Email address:

email@not.entered

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, Hermanos Ameijeiras Hospital, Adlin Lopez Diaz, Bachelor in Physics.

Research ethics committees:

National Institute of Oncology and Radiobiology (INOR), July 23, 2004.

Hermanos Ameijeiras Hospital, June 30, 2007.

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

29/10/2005

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:

Metastatic breast tumor

Health condition(s) code:

Breast Neoplasms

Breast Diseases

Intervention(s):

One single 1-mg dose of 30-40mCi of 99mTc-marked 14F7 MaB will be administered intravenously within 1-2 minutes, volume exceeding 1mL. Patients with metastasis located in contralateral breast will have the product administered through pedis artery.

Intervention code:

Radionuclide Imaging

Radioimmunodetection

Antibodies, Monoclonal

Administration, Intravenous

Radioisotopes

Injections, Intra-Arterial

Intervention keyword:

AcM 14F7, Immunoscintigraphy

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):

Gamma graphic positivity, Measuring time: 24 hours.

Key secondary outcomes:

Concordance degree, sensitivity, specificity, predictive positive value, predictive negative value, and Toxicity. Measuring time: 24 hours.

Selection criterias

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

Gender:

Female

Minimum age:

18 years

Maximum age:

80 years

Inclusion criteria:

1) Patients giving their consent in writing to participate in the clinical trial. 2) Patients with breast carcinoma, phase IV upon diagnosis, or evolving metastatic disease, with cyto-histological confirmation of base disease and of metastasis by imaging and cyto-histological tests. 3) Patients aged 18 to 80. 4) Patients whose general condition is lower than or equal to 2 under WHO criteria. 5) Preserved kidney function with creatinine values within normal limits (35-132 mmol/L). 6) Patients with hemoglobin values over 10g/L, leucocytes over 4,000/mm3, platelets 100 x 109, and transaminase and alkaline phosphatase up to 2.5 times higher than normal reference values. 7) Female patients will be included in the study.

Exclusion criteria:

1) Pregnancy and breastfeeding. 2) Reproductive-age patients not using contraceptive methods. 3) Fever due to acute or serious infectious diseases or convalescence (not exceeding 37.5oC). 4) Patients with history of uncontrolled chronic diseases such as asthma, ischemic cardiopathy, diabetes mellitus, hepatitis, and high blood pressure. 5) Patients with allergic conditions or history of severe allergic reactions. 6) Patients who have previously been on any murine or humanized MAb therapy.

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:

Diagnostic

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

2

Target sample size:

21

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:

Angel

Middle Name:

Raimundo

Last Name:

Casaco Parada

Specialty:

Specialist 2nd Grade in Normal and Pathological Physiology

Affiliation:

Center of Molecular Inmunology (CIM)

Postal Address:

216 Street and 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

CP 16040, Box11600

Telephone:

(537) 271-7933 Ext 224

Email :

casaco@cim.sld.cu

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:

Angel

Middle Name:

Raimundo

Last Name:

Casaco Parada

Specialty:

Specialist 2nd Grade in Normal and Pathological Physiology

Affiliation:

Center of Molecular Inmunology (CIM)

Postal Address:

216 Street and 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

CP 16040, Box11600

Telephone:

(537) 271-7933 Ext 224

Email :

casaco@cim.sld.cu

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:

RPCEC00000025

Date of Registration in Primary Registry:

2008-12-27

Record Verification Date:

2017/01/23

Next update date:

2018/01/23

Link to the spanish version:

Click here

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99mTc-marked 14F7 MaB in metastatic breast, phase II

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