Clinical trial, phase II: Evaluation of TheraCIM hR3 MaB combined with chemo- and radio-therapy to treat patients with epithelial tumors in neck of the uterus, stage III.

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000054
• Date of registration: 27/12/2010
• Primary sponsor: Center of Molecular Inmununology(CIM)
• Public title: Clinical trial, phase II: Evaluation of TheraCIM hR3 MaB combined with chemo- and radio-therapy to treat patients with epithelial tumors in neck of the uterus, stage III.
• Scientific title: Clinical trial, phase II: Evaluation of TheraCIM hR3 MaB combined with chemo- and radio-therapy to treat patients with epithelial tumors in neck of the uterus, stage III.
• Date of first enrolment: 30/05/2007
• Target sample size: 148
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000054-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Single Blind Placebo: Placebo Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Mayra Ramos Suzarte
• Affiliation: Center of Molecular Immunology (CIM)

• Name: Mayra Mayra Ramos Suzarte
• Affiliation: Center of Molecular Immunology (CIM)

Key inclusion & exclusion criteria

Inclusion criteria: 1) Patients giving their consent in writing to participate in the trial. 2) Female patients with measurable lesions, defined as those that can be exactly measured in one dimension at least (greater diameter) and have a diameter equal to or higher than 20mm, using conventional techniques (abdominal CAT, X rays, US), or higher than or equal to 10mm, using spiral CAT or clinical tests. 3) Patients aged 18 to 70. 4) General condition under ECOG =2. 5) Patients whose organs and bone marrow are working normally, as defined by the following parameters: - Hemoglobin >= 10g/L - Leucocytes >= 4,000/mL- Absolute neutrophil count >= 1,500/mL – Platelet count >= 100,000/L – Total bilirubin: up to 1.5 times the normal value - Total proteins: Within normal limits - TGP and TGO <= 2.5 times the institutional higher normal value – Serum creatinine: Within normal limits, and glomerular filtering based on Cockcrof Formula – Creatinine clearing = (140-age) x weight (kg)/72 x serum creatinine. Following clinical criteria, glomerular filtering will be performed only on patients whose kidney function is thought to be affected. (Normal laboratory values will be in keeping with the technology and equipment available where tests are conducted). 6) Female patients will be included in the study.
Exclusion criteria: 1. Pregnancy or breastfeeding. 2. Patients on another onco-specific drug under research (except EPOCIM and/or LeukoCIM). 3. Patients with history of allergy to chemical and biological compounds similar to the monoclonal antibody under evaluation. 4. Patients with uncontrolled intercurrent diseases, including active infections, symptomatic congestive cardiac failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes, and psychiatric diseases. 5. Presence of a second tumor, except patients who have been on appropriate treatment for skin (basal or scaly) carcinomas.

Age minimum: 18 years
Age maximum: 70 years
Gender: Female

Health Condition(s) or Problem(s) studied

Epithelial tumors in neck of the uterus, stage III.

Intervention(s)

Study group: A total of 200mg of TheraCIM hR3 MAb will be administered 9 times, combined with chemo- and radiotherapy. Dose 1. Prior to chemo- and radio-therapy. Dose 2-7. Together with the administration of six week treatment with chemo- and radio-therapy. Dose 8. Alone. Dose 9. First week of brachytherapy. TheraCIM hR3 MAb will in all cases be administered intravenously (antecubital vein), in 250mL of saline solution in infusion, during 30 minutes approximately. Control group: The patients will receive chemotherapy and radiotherapy like the study group.

Primary Outcome(s)

Survival, measuring time: 2 years.

Secondary Outcome(s)

Antitumoral response, progression time, safety, HAMA response, reduced associated symptoms, measuring time: 3 months.

Secondary ID(s)

IIC RD-EC078

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable