99mtc-marked 14f7 MAb in colon/rectum tumor, 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:

Inmuno gamma scanning with 99mtc-marked 14f7 MAbB in patients with colon/rectum tumor, Phase II

Secondary indentifying numbers:

IIC RD-EC072

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 :

03/11/2004

Reference number:

2147/05.025.04B

Principal investigator

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

First name:

Mayte

Last name:

Lima Perez

Medical Specialty :

1st degree specialist in oncology

Affiliation:

Hermanos Ameijeiras Hospital

Postal address:

San Lazaro 701 esq. Belascoain

City:

Havana

País:

Cuba

Zip Code:

10300

Telephone:

+53-78761000

Email address:

email@not.entered [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:

Hermanos Ameijeiras hospital (HHA), July 5th, 2004.

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

10/05/2005

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:

Colon/rectum tumor

Health condition(s) code:

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Rectal Diseases

Colonic Diseases

Intestinal Diseases

Gastrointestinal Diseases

Digestive System Diseases

Intervention(s):

A single administration of 1mg of 14f7 MAb marked with 30-40 mCi 99mTc. The product will be intravenously administered in a 1 to 2 minute time span and a volume higher than 1mL

Intervention code:

Radionuclide Imaging

Radioimmunodetection

Antibodies, Monoclonal

Administration, Intravenous

Radioisotopes

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):

Positive responses. Measuring time: 1 day

Key secondary outcomes:

Concordance grade, sensitivity, specificity, positive predictive value, negative predictive value, toxicity. Measuring time: 1 month after 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:

18 years

Maximum age:

80 years

Inclusion criteria:

1.Patients expressing their consent in writing to participate in the clinical trial. 2.Patients between 18 and 80 years of age. 3.Patients without another neoplasia history, except basal skin carcinoma or in situ cervical carcinoma. 4.Patients with general health condition lower than or equal to 2, according to WHO criteria. 5.Preserved kidney function with a creatinine parameter lower than 132 mmol/l. 6.Patients with hemoglobin values over 10 g/l, leukocytes over 4000 /mm3, platelets 100 x 109 and transaminase and alkaline phosphatase within 2.5 times the normal reference values. 7.The study will include patients of both sexes.

Exclusion criteria:

1.Pregnancy or breastfeeding. 2.Reproductive-age patients not using contraceptive methods. 3.Fever due to acute or serious infectious diseases or convalescence (not exceeding 37oC). 4.Patients with history of decompensated chronic diseases such as: asthma, ischemic heart disease, diabetes mellitus, hepatitis and high blood pressure. 5.Patients with acute allergic conditions or history of severe allergic reactions. 6.Patients previously treated with 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:

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:

Angel

Middle Name:

Raimundo

Last Name:

Casaco Parada

Specialty:

Specialist of 2nd Degree in Normal and Pathological Physiology

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

(537) 271-7933 Ext 224

Email :

casaco@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:

Angel

Middle Name:

Raimundo

Last Name:

Casaco Parada

Specialty:

Specialist of 2nd Degree in Normal and Pathological Physiology

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

(537) 271-7933 Ext 224

Email :

casaco@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:

RPCEC00000069

Date of Registration in Primary Registry:

2010-12-17

Record Verification Date:

2008-07-14 20:00

Link to the spanish version:

Click here [3]