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.

Phase 2

• Conditions: Epithelial tumors in neck of the uterus, stage III.; Genital Neoplasms, Female; Genital Diseases, Female; Female Urogenital Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Cervical Intraepithelial Neoplasia; Uterine Cervical Diseases; Uterine Cervical Neoplasms

• Registration Number: RPCEC00000054
• Lead Sponsor: Center of Molecular Inmununology(CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 148

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival, measuring time: 2 years.

Secondary Outcome Measures

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