Trials / Terminated
TerminatedNCT02758366
Prolonged Exposure to Doxorubicin in Patients With Glioblastoma Multiforme and Diffuse Intrinsic Pontine Glioma
An Open-label, Single-arm, Phase II Study to Evaluate Safety and Efficacy of Doxorubicin in Combination With Radiotherapy, Temozolomide and Valproic Acid in Patients With Glioblastoma Multiforme (GBM) and Diffuse Intrinsic Pontine Glioma (DIPG)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Meyer Children's Hospital IRCCS · Academic / Other
- Sex
- All
- Age
- 3 Years – 30 Years
- Healthy volunteers
- Not accepted
Summary
The standard therapy of glioblastoma (GBM) consists of gross total resection followed by focal irradiation to the tumor bed with concomitant and adjuvant temozolomide (TMZ). The association of valproic acid and TMZ during radiotherapy improves survival of GBM. Preclinical studies suggested that doxorubicin had a strong antineoplastic activity against human gliomas. Moreover, some studies showed that the continuous infusion of anthracyclines in patients with solid tumor ensured a better safety profile compared with bolus administration. Based on these findings, the purpose of this study is to evaluate safety and efficacy of prolonged administration of doxorubicin in combination with radiotherapy, temozolomide and valproic acid in pediatric and adult patients with newly diagnosed GBM and diffuse intrinsic pontine glioma (DIPG).
Conditions
- Glioblastoma (GBM)
- DIPG
- Brainstem Glioma, Pediatric
- Diffuse Spinal Glioma
- Bilateral Thalamic Glioma
- Gliomatosis Cerebri
- Anaplastic Astrocytoma
- Midline Diffuse Glioma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Doxorubicin |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2020-01-16
- Completion
- 2020-01-16
- First posted
- 2016-05-02
- Last updated
- 2021-02-09
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT02758366. Inclusion in this directory is not an endorsement.