CompletedPhase 2

Nimotuzumab and Radiotherapy in Pediatric Patients With Glioma

Brazil, Cuba40 participantsStarted 2011-03

Plain-language summary

The study consists in only one treatment group, which will receive the first-line therapy for the disease - standard radiotherapy and a 150 mg/m2 dose of the investigational product (nimotuzumab)

Who can participate

Age range

3 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Pediatric patients with diffuse intrinsic brainstem gliomas, documented by standard imaging techniques (MRI). Note: Tumor biopsy and histological confirmation are not required in this study.
. Patients eligible for radiotherapy with Cobalt60. The patients should not have received a previous specific oncological treatment.
. Aged \> 3 years old \< 18 years old
. Patients with measurable lesions, defined as those that can be accurately measured in at least 2 dimensions (the 2 largest perpendicular diameters), using standard techniques (MRI).
. Female patients with childbearing potential should present a negative pregnancy test and adopt effective birth control methods, in case they are sexually active.
. Male patients who can father a child should adopt effective birth control methods, in case they are sexually active.
. Life expectancy \> 12 weeks
. Health general status, according to Karnofsky Index \> 40% (Karnofsky Index for patients \> 16 years old), Lansky \> 40% (for patients \< 16 years old)

Exclusion criteria

. Low-grade brainstem glioma (e.g., focal, cervicomedullary, tectal brainstem glioma).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Tumor Volume

Timeframe: 6 months

Trial details

NCT IDNCT01145170

SponsorEurofarma Laboratorios S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-06

View on ClinicalTrials.gov More Diffuse Intrinsic Brainstem Gliomas trials