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

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000071
• Date of registration: 17/12/2010
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: Use of h-R3 monoclonal antibody and radiotherapy to treat patients with advanced epithelial head and neck tumors.
• Scientific title: Phase Ib/IIa clinical trial: Use of h-R3 monoclonal antibody and radiotherapy to treat patients with advanced epithelial head and neck tumors.
• Date of first enrolment: 09/08/1999
• Target sample size: 12
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000071-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Other Purpose: Treatment Other design features: Dose escalations

Countries of recruitment

Cuba

Contacts

• Name: Tania Crombet Ramos
• Affiliation: Center of Molecular Immunology (CIM)

• Name: Tania Crombet Ramos
• Affiliation: Center of Molecular Immunology (CIM)

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: 75 years
Gender: Both

Health Condition(s) or Problem(s) studied

Advanced epithelial head and neck tumors.

Intervention(s)

Four levels of MAb hR3 doses Level 1: 50 mg once a week, for 6 weeks (Total doses: 300 mg) Level 2: 100 mg once a week, for 6 weeks (Total doses: 600 mg) Level 3: 200 mg once a week, for 6 weeks (Total doses: 1200 mg) Level 4: 400 mg once a week, for 6 weeks (Total doses: 2400 mg ) During that time, the patient will be on conventional radiant treatment.

Primary Outcome(s)

Antitumoral effect. Measuring time: 12 months.

Secondary Outcome(s)

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

Secondary ID(s)

IIC RD-EC040

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable