Study of intensive pediatric pharmacovigilance of nimotuzumab for the treatment of malignant glioma tumors.

Study of intensive pediatric pharmacovigilance of monoclonal antibody nimotuzumab for the treatment of malignant glioma tumors

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000183

Enrollment

160

Registered

2014-08-14

Start date

2006-02-10

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant gliomas

Interventions

Scheme 1: Surgery + Radiotherapy (54-60 Gy) + Nimotuzumab + Chemotherapy (Cisplatin + Cyclophosphamide, procarbazine

Carboplatin + Etopoxide). Scheme 2: Surgery + Radiotherapy (54-60 Gy) + Nimotuzumab. Scheme 3: Nimotuzumab (monotherapy). Scheme of Nimotuzumab: Induction phase: Once a week for 6 weeks, by intraven

Eligibility

Sex/Gender

All

Age

2 Years to 19 Years

Inclusion criteria

Inclusion criteria: 1. Children and adolescents between 2 and 19 years of age of btoh gender (male and female) 2. Diagnoses by histology/pathology documented or by images if stem tumor. 3. Life expectancy of at least 4 weeks. 4. Karnofsky / Lansky = 50%.

Exclusion criteria

Exclusion criteria: 1. Participation in another trial. 2. Pregnant or breastfeeding. 3. Decompensated chronic disease. 4. Acute septic processes.

Design outcomes

Primary

Measure	Time frame
Serious Adverse Events with causal relationship with the Nimotuzumab (Recorded serious AE with definitive, very likely or likely causality relationship with the use of the Nimotuzumab). Measurement time: up to 2 years of follow-up after 1 dose of the monoclonal.	—

Secondary

Measure	Time frame
Number of doses received (total number of doses received by patient). Measurement time: up to 2 years. Occurrence of any Adverse Events (AE) (Yes, No). Measurement time: up to 24 months of follow-up after 1 dose of the monoclonal. - AE description (type of AE notified) - AE intensity (Common Terminology Criteria for Adverse Events, CTCAE). - AE duration (date between the start and the completion of AE). - Causal relationship (Very likely, Likely, Possible, Unlikely, Unrelated, Not evaluable /no classifiable) Overall survival (Duration from date of recruitment to date of death from any cause or the last date that has news of the patient). Measurement time: up to 2 years of follow-up after 1 dose of the monoclonal. Objective clinical response (MacDonals classification: complete response (RC), partial response (PR) stable disease (EE) and progression disease (PD)). Measurement time: the 12 weeks of treatment and every 3 months up to 2 years. Cognitive State (description according to the scale used). Measurement time: 6 months, 12 months and 24 months. EGFR Expression (immunohistochemistry evaluation in biopsy). Measurement time: at baseline and if surgery is needed again. Images markers (magnetic resonance imaging and magnetic resonance spectroscopy. Measurement time: at baseline and every 12 weeks until 2 years of follow-up.	—

Measure

Time frame

Number of doses received (total number of doses received by patient). Measurement time: up to 2 years. Occurrence of any Adverse Events (AE) (Yes, No). Measurement time: up to 24 months of follow-up after 1 dose of the monoclonal. - AE description (type of AE notified) - AE intensity (Common Terminology Criteria for Adverse Events, CTCAE). - AE duration (date between the start and the completion of AE). - Causal relationship (Very likely, Likely, Possible, Unlikely, Unrelated, Not evaluable /no classifiable) Overall survival (Duration from date of recruitment to date of death from any cause or the last date that has news of the patient). Measurement time: up to 2 years of follow-up after 1 dose of the monoclonal. Objective clinical response (MacDonals classification: complete response (RC), partial response (PR) stable disease (EE) and progression disease (PD)). Measurement time: the 12 weeks of treatment and every 3 months up to 2 years. Cognitive State (description according to the scale used). Measurement time: 6 months, 12 months and 24 months. EGFR Expression (immunohistochemistry evaluation in biopsy). Measurement time: at baseline and if surgery is needed again. Images markers (magnetic resonance imaging and magnetic resonance spectroscopy. Measurement time: at baseline and every 12 weeks until 2 years of follow-up.

—

Countries

Cuba

Contacts

Public ContactDr. Giselle Saurez Martinez

CIMAB S.A

giselle@cim.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026