Trial · NCT01165333
Cilengitide in Combination With Irradiation in Children With Diffuse Intrinsic Pontine Glioma
NCT01165333, Phase 1, Completed, Centre Oscar Lambret
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cilengitide in Combination With Irradiation in Children With Diffuse Intrinsic Pontine Glioma. Trials, record NCT01165333. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01165333
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cilengitide in Combination With Irradiation in Children With Diffuse Intrinsic Pontine Glioma
- NCT number
- NCT01165333
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 32 participants, actual
- Lead sponsor
- Centre Oscar Lambret
- Conditions
- Diffuse Intrinsic Pontine Glioma
- Interventions
- Cilengitide dose escalation, Cilengitide, Concomitant radiotherapy, Pharmacokinetic, Pharmacogenetic, Exploratory investigation
- First posted
- 2010-07-19
- Last updated
- 2026-03-16
- Other registries' IDs
- eudract:2009-016870-33
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determination of the Maximal Tolerated Dose of Cilengitide | After 6 weeks of treatment | A DLT is defined below: Hematological toxicity: * grade 4 neutropenia for more than 5 days * grade 3 or 4 neutropenia with documented infection * grade 3 or 4 thrombopenia for more than 5 days * requirement of platelet transfusion support for more than 5 days Non-hematological toxicity: Any grade 3 or 4 non-hematological toxicity of whatever duration with the exception of (i) nausea/vomiting without appropriate treatment, and (ii)isolated, transient fever occurring outside an episode of neutropenia), with the exclusion of toxicities related to any other well-identified cause. |
| Secondary | Safety profile of the Cilengitide | During all the study | toxicities (NCI-CTCAE v4.0) |
| Secondary | study of the pharmacoKinetic profile of Cilengitide | Day 1 and 2 of first cycle | Blood samples of 2 mL will be collected at each time point : before Cilengitide infusion, at the end of infusion, 30 mn after the end of infusion, 60 mn, 90 mn, 2 hrs, 4 hrs, 6 hrs, 24 hrs after the end of infusion |
| Secondary | estimate efficacy in terms of response according to histopathology | Every 3 cycles | WHO criteria |
| Secondary | Progression-free and overall survival | During all the study | 6-month-PFS overall survival |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01165333
GET https://conductscience.org/api/trials/v1/NCT01165333/registered