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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| glioma brain stem | Experimental |
| |
| high grade recurrent brain tumor in the central nervous system | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania | Drug | Sol-gel process Pt(acac)2- F-TiO2 nanostructured material with antitumoral activity used as an alternative in the treatment of cancer tumors. The biocatalysts were prepared by the sol-gel route using the complex Pt(acac)2. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the quality of life using the PedsQL Cancer Module© | Measures of the change of quality of life pre and after the administration of NPt-Ca using the questionnaire PedsQL Cancer Module© | Preoperative and at 1.3, 6, 12, 18 and 24 months. |
| Change in tumor size | Change in tumor size after the administration of NPt-Ca using volumetric measures on the brain magnetic resonance. | Immediate, 1, 2, 3, 6, 8, 10, 12, 18 and 24 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Infantil de Mexico Federico Gomez | DF | Mexico |
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|
|
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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