Brain Tumor, Pediatric, Brainstem GliomaEarly Phase 1NCT03250520
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
A Early Phase 1 study testing Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania in people with Brain Tumor, Pediatric, Brainstem Glioma and Brain Tumor, Pediatric, Recurrent, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Brain Tumor, Pediatric, Brainstem Glioma, Brain Tumor, Pediatric, Recurrent
- What is being tested?
- Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2017to 28 Jun 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Being tested
- Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania
- Medical subject headings
- Brain Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titaniaDrug
Also called Pt(acac)2/Titanium dioxide (Ti02), Pt(acac)2/F-TiO2, NPt, NPt-Ca
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.
| Study group | Role | What they receive |
|---|---|---|
| glioma brain stem | Experimental | Not described Receives: Drug: Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania |
| high grade recurrent brain tumor in the central nervous system | Experimental | Not described Receives: Drug: Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania |
What is being measured
The primary outcome is the main question the study is designed to answer.
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©
Measured: 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.
Measured: Immediate, 1, 2, 3, 6, 8, 10, 12, 18 and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start1 Sep 2017
- Primary completion28 Jan 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumor, Pediatric, Brainstem GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Infantil de Mexico Federico Gomez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Eduardo Alvarez Amado, Hospital Infantil de Mexico Federico Gomez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250520
- Sponsor's protocol ID
- HIM 2017-072
- Status last verified
- Feb 2023
- First submitted
- 10 Jun 2017
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03250520
- Acronym / sponsor ID
- HIM 2017-072
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hospital Infantil de Mexico Federico GomezUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glioma brain stem | Experimental | Drug: Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania |
| high grade recurrent brain tumor in the central nervous system | Experimental | Drug: Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titaniaAlso: Pt(acac)2/Titanium dioxide (Ti02), Pt(acac)2/F-TiO2, NPt, NPt-CaSol-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. | Drug | glioma brain stem, high grade recurrent brain tumor in the central nervous system |
Primary outcome
Change in the quality of life using the PedsQL Cancer Module©
Time frame: Preoperative and at 1.3, 6, 12, 18 and 24 months.
Measures of the change of quality of life pre and after the administration of NPt-Ca using the questionnaire PedsQL Cancer Module©
Change in tumor size
Time frame: Immediate, 1, 2, 3, 6, 8, 10, 12, 18 and 24 months.
Change in tumor size after the administration of NPt-Ca using volumetric measures on the brain magnetic resonance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania in people with Brain Tumor, Pediatric, Brainstem Glioma and Brain Tumor, Pediatric, Recurrent, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the quality of life using the PedsQL Cancer Module© (time frame: Preoperative and at 1.3, 6, 12, 18 and 24 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.