|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
RPCEC |
|
Last refreshed on:
|
27 May 2013 |
|
Main ID: |
RPCEC00000042 |
|
Date of registration:
|
20/12/2010 |
|
Primary sponsor: |
|
|
Public title:
|
AntiCEA M3-I
|
|
Scientific title:
|
Evaluation of a multivalent fragment of radiomarked anti-CEA antibody in colorectal cancer patients. Clinical trial, phase I. |
|
Date of first enrolment:
|
14/05/2007 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Active |
|
URL:
|
http://registroclinico.sld.cu/trials/RPCEC00000042-En |
|
Study type:
|
Interventional |
|
Study design:
|
Randomization: Nonrandomized Trial Blinding: Open. Placebo: Uncontrolled Assignment: Other Purpose: Diagnostic Other design features:
|
|
|
Countries of recruitment
|
|
Cuba
| | | | | | | |
|
Contacts
|
|
Name:
|
Idrian
Garcia Garcia |
|
Address:
|
134 street, between 23 and 25 street. Cubanacan, Playa
6162
Havana City
Cuba |
|
Telephone:
|
(53-7)- 2087379 |
|
Email:
|
idrian.garcia@cigb.edu.cu |
|
Affiliation:
|
Clinical Trials Division, Center for Biological Research |
|
|
Name:
|
MSc. Idrian
Garcia Garcia |
|
Address:
|
134 street, between 23 and 25 street. Cubanacan, Playa
6162
Havana City
Cuba |
|
Telephone:
|
(53-7)- 2087379 |
|
Email:
|
idrian.garcia@cigb.edu.cu |
|
Affiliation:
|
Clinical Trials Division, Center for Biological Research |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Histological diagnosis of colon or rectum adenocarcinoma, any clinical stage, with no previous Onco-specific treatment. Demonstration of CEA antigen expression in tumoral tissue using immunohistochemical technique. General clinical condition lower than or equal to 2 under WHO criteria. Patients aged 18 to 80, both sexes, any race. Contraceptive use in reproductive age women. Patients giving informed consent in writing to participate in the research and undergo relevant tests.
Exclusion criteria: History of neoplasia other than basocellular skin carcinoma or in situ cervix carcinoma. Previous onco-specific treatment. Previous administration of any murine, chimeric or humanized antibody. History of allergy or hypersensitivity to iodine-containing preparations. Uncontrolled chronic diseases such as asthma, ischemic cardiopathy, diabetes mellitus, viral hepatitis, and high blood pressure. Hemoglobin values <10 g/L, total leucocytes <4,000/mm3, and platelets <100 x 109 cel/L. Kidney failure caused by creatinine clearing values < 60 mL/min, and liver failure caused by TGP and/or TGO values 2.5 times higher than the normal upper limit in technique under use. Fever due to acute or serious infectious diseases or convalescence (not exceeding 37.50C). Pregnancy, breastfeeding or puerperium. Reproductive age women with positive pregnancy tests. Serious psychiatric or neurological disorder or mental handicap.
Age minimum:
18 years
Age maximum:
80 years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Colorectal cancer
|
|
Intervention(s)
|
|
The trial will involve 20 adult patients with colorectal cancer, to be divided into 2 10-member groups for each dose level. One single intravenous dose of 0.3 or 1mg of fragment marked with 5-7 mCi of 131I will be administered, depending on the group.
|
|
Primary Outcome(s)
|
|
Pharmaceutical safety, measuring time: 6 months.
|
|
Secondary Outcome(s)
|
|
Biodistribution and internal dosage, measuring time: 72 hours. Pharmacokinetics, measuring time: 72 hours.
|
|
Secondary ID(s)
|
|
IG/DAI/NC/0601
|
|
Source(s) of Monetary Support
|
|
Ministry of Public Health, CUBA
|
|