se of h-R3 monoclonal antibody and radiotherapy to treat patients with advanced epithelial head and neck tumors.

Phase 1

• Conditions: Advanced epithelial head and neck tumors.; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial

• Registration Number: RPCEC00000071
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1.Patients with epithelial head and neck tumors in oral cavity and mesopharynx, stages III or IV, eligible for radiant treatment. 2.Patients with epithelial head and neck tumors not eligible for surgical treatment or undergoing relapse upon inclusion. 3.EGF-R expression confirmation by immunohistochemistry. 4.Patient’s consent in writing. 5.Age from 18 to 75 years, of both sexes. 6.WHO Performance Status lower than or equal to 2. 7.Six month life expectancy. 8.Clinical laboratory parameters: Hb >10 g/l; total leukocytes over 4 x 109 cells/l; platelets > 100 x 109/L. Liver function within normal limits and/or patients with history of liver condition confirmed by TGP, TGO or alkaline phosphatase. Kidney function: serum creatinine?132 mmol/l.

Exclusion Criteria

1.Non compliance with inclusion criteria. 2.Patients treated with murine R3 MaB. 3.Pregnancy or breastfeeding. 4.Decompensated chronic disease: cardiopathy, diabetes, high blood pressure. 5.History of hypersensitivity to this or any similar product. 6.Fever 7.Severe septic processes. 8.Acute or serious allergic conditions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antitumoral effect. Measuring time: 12 months.

Secondary Outcome Measures

Name	Time	Method
Adverse reactions and maximum permissible dose. Measuring time: 12 months.