Status:
COMPLETED
Application of Palliative Treatment in Children With Brain Stem Glioma and Recurrent High-grade Tumors in the Central Nervous System With the Nanomaterial NPt-Ca
Lead Sponsor:
Hospital Infantil de Mexico Federico Gomez
Conditions:
Brain Tumor, Pediatric, Brainstem Glioma
Brain Tumor, Pediatric, Recurrent
Eligibility:
All Genders
5-14 years
Phase:
EARLY_PHASE1
Brief Summary
This Protocol is a pilot, clinical interventional study to selected patients between five and fourteen years of both sexes, carriers of the diagnosis of glioma brain stem and high grade recurrent in t...
Eligibility Criteria
Inclusion
- Histopathological diagnosis or MRI of the brain stem or tumor of recurrent high-grade glioma.
- Indication of palliative surgical treatment by neurosurgery.
- Good general condition, enabling the realization of surgical treatment.
- Scale Lansky \> 20)
- conventional treatment (surgery, radiotherapy, and chemotherapy) failed or not applicable to the patient.
Exclusion
- Patients with emerging infectious diseases or fever in the last 72 hours prior to placement of the NPt-Ca.
- Patients whose parents/carers do not authorize expressly the realization of procedure with knowledge of its experimental nature, are not agreed or established their commitment to meet follow-up parameters established by this Protocol.
- Patients with surgical complications prior to placement of the NPt-Ca.
- Patients in which the size and location of the lesion do not allow their surgical approach or an increase in volume by infiltration of the lesion with 3 ml of volume of NPt-Ca.
- Patient whose neurological condition do not allow the implementation of MRI without anesthesia.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03250520
Start Date
September 1 2017
End Date
June 28 2022
Last Update
February 28 2023
Active Locations (1)
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1
Hospital Infantil de Mexico Federico Gomez
DF, Mexico