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

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000069
• Date of registration: 17/12/2010
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: 99mtc-marked 14f7 MAb in colon/rectum tumor, Phase II
• Scientific title: Inmuno gamma scanning with 99mtc-marked 14f7 MAbB in patients with colon/rectum tumor, Phase II
• Date of first enrolment: 10/05/2005
• Target sample size: 20
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000069-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Diagnostic

Countries of recruitment

Cuba

Contacts

• Name: Angel Casaco Parada
• Affiliation: Center of Molecular Immunology (CIM)

• Name: Angel Casaco Parada
• Affiliation: Center of Molecular Immunology (CIM)

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: 80 years
Gender: Both

Health Condition(s) or Problem(s) studied

Colon/rectum tumor

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

Primary Outcome(s)

Positive responses. Measuring time: 1 day

Secondary Outcome(s)

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

Secondary ID(s)

IIC RD-EC072

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable