Clinical trial NCT03250520: 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
Official title: Pilot Study of the Application of Palliative Treatment in Children With Brain Stem Glioma and Recurrent High-grade Tumors in the Central Nervous System With the Nanomaterial Platinum Acetylacetonate (1% wt) Supported by Sol-gel Technology Functionalized Titania (NPt-Ca)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Brain Tumor, Pediatric, Brainstem Glioma
Brain Tumor, Pediatric, Recurrent
Lead sponsor: Hospital Infantil de Mexico Federico Gomez
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 8
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 the central nervous system tumors, in whom there has been no response to conventional-based surgery/radiation/chemotherapy treatment or whose location does not allow treatment with conventional measures, and that already have an indication for a neurosurgical palliative procedure. It will be a close pharmacovigilance on possible adverse effects related to the nanomaterial based on the profile of cisplatin (chemotherapeutic platinum derivative), since documented toxicity data are not counted for NPt-Ca. Quality of life will be documented with PedsQL Cancer Module© and tumor size by magnetic resonance brain images.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change in the quality of life using the PedsQL Cancer Module©
timeFrame: Preoperative and at 1.3, 6, 12, 18 and 24 months.
measure: Change in tumor size
timeFrame: Immediate, 1, 2, 3, 6, 8, 10, 12, 18 and 24 months.
Secondary outcomes:
Other outcomes:
Locations:
city: DF
country: Mexico
facility: Hospital Infantil de Mexico Federico Gomez
Study officials:
References: