14F7 MAb marked with Tc99 Phase II in breast tumors.

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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 using 14F7 MAbB marked with Tc99 in patients with metastatic breast tumor, phase II.

Secondary indentifying numbers:

IIC RD-EC061

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (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 :

27/09/2002

Reference number:

154/05.043.01B

Principal investigator

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

First name:

Juan Perfecto Oliva Gonzalez, MD, PhD in Medical Sciencies. 2nd degree Specialist in Oncology.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

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:

Not applicable

Research ethics committees:

National Institute of Oncology and Radiobiology (INOR), July 24, 2001

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

13/02/2003

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 tumors.

Intervention(s):

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

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):

Toxicity. Measuring time: 24 hours.

Key secondary outcomes:

Pharmacokinetics, biodistribution, internal dosage and gammagraphic positive tests. 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 (to participate in the clinical trial) in writing. 2)Patients with breast carcinoma phase IV upon diagnosis or evolving metastatic disease, with cyto-histological confirmation of base disease and metastasis by imaging or cyto-histological test. 3)Patients aged between 18 and 80 both inclusive. 4)Patients with general condition lower than or equal to 2, according to WHO criteria. 5)Preserved kidney function with normal creatinine values ranking from 35 to 132mmol/l. 6)Patients with hemoglobin values over 10g/l, leucocytes over 4,000 /mm3, platelets 100 x 109, transaminase and alkaline phosphatase up to 2.5 times over normal reference values.

Exclusion criteria:

1)Pregnancy or breastfeeding. 2)Reproductive-age patients not using contraceptives. 3)Feverish condition due to acute or serious infectious diseases or convalescence (not exceeding 37.5 oC). 4)Patients who have suffered from decompensated chronic diseases such as asthma, ischemic cardiopathy, diabetes mellitus, hepatitis or high blood pressure. 5)Patients with acute allergic conditions or severe allergic reaction history. 6)Patients who have previously been on some murine or humanized MAb.

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:

15

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

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana City

Country:

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

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana City

Country:

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:

RPCEC00000024

Date of Registration in Primary Registry:

2010-12-29

Record Verification Date:

2008-01-17 19:00

Link to the spanish version:

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Registered Trials

Registration process

14F7 MAb marked with Tc99 Phase II in breast tumors.

About the RPCEC

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