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Study of the treatment of children and adolescents with diffuse brainstem tumors using Valproic Acid with Chemotherapy and Radiation Therapy

Clinical trial of valproic acid with radiochemotherapy for diffuse pontine intrinsic glioma patients - VALKYRIE: Valproic acid with radiochemotherapy for DIPG

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-7ygspd
Enrollment
Unknown
Registered
2016-05-30
Start date
2017-01-02
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma, brain stem neoplasm

Interventions

A group of 16 children and adolescents with diffuse intrinsic pontine glioma will receive treatment with radiochemotherapy and oral valproic acid. Event-free survival, global survival and quality of l
Drug
Radiation
D02.241.081.944.509.900
E02.183.750.500
E02.815.635.700

Sponsors

Hospital Infantil Albert Sabin
Lead Sponsor
Hospital Infantil Albert Sabin
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients between 0 and 18 years diagnosed with DIPG by imaging. Absence of acute cerebral bleeding. It includes subdural hematoma, subarachnoid and intraparenchymal bleeding. No prior treatment with chemotherapy or radiotherapy.

Exclusion criteria

Exclusion criteria: History of recent head trauma. Coma with brain herniation. Coagulopathy (platelet counts 1.8). Previous recent use of valproic acid. Use of other anti-convulsant drugs.

Design outcomes

Primary

MeasureTime frame
Survival probability distribution of patients treated with radiochemotherapy combined with valproic acid, estimated by Kaplan-Meyer method and plotted as percent probability versus time from treatment, with 95% confidence intervals.—

Secondary

MeasureTime frame
Median survival in months estimated by Kaplan-Meyer method and compared by a log-rank test with that from the original group that used a similar chemoradiation protocol (HIT-GBM-D); comparison of the median survival with the historical group of patients with the same diagnosis treated in same institution by a log-rank test; comparison of the median survival with that from the group treated in a national clinical trial previously published, using a log-rank test; RANO radiological response (%) of patients 2 months after the end of radiation therapy; progression-free survival 6 months after the beginning of the treatment, estimated by Kaplan-Meier method; quality of life of patients after the end of treatment, evaluated with PEDS-QL scale and expressed as percentile; incidence of severe toxicity, evaluated by NCI criteria and expressed in absolute count and relative percentile.—

Countries

Brazil

Contacts

Public ContactFrancisco Felix

Hospital Infantil Albert Sabin

heldercfelix@gmail.com+55(85)32579613

Outcome results

None listed

Source: REBEC (via WHO ICTRP)