99mtc-marked 14f7 MAb in colon/rectum tumor, Phase II
- Conditions
- Colon/rectum tumorColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsRectal DiseasesColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases
- Registration Number
- RPCEC00000069
- Lead Sponsor
- Center of Molecular Immunology (CIM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Positive responses. Measuring time: 1 day
- Secondary Outcome Measures
Name Time Method Concordance grade, sensitivity, specificity, positive predictive value, negative predictive value, toxicity. Measuring time: 1 month after treatment.