Clinical trial · Interventional
Study of Re-irradiation at Relapse Versus RT and Multiple Elective rt Courses
Phase 2 Randomized Study of RT and Reirradiation at Relapse vs Multiple Elective RT Courses With Same Concomitant CT for Newly Diagnosed
NCT03620032CI-TRIAL-00072004DIPGunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective, non-blinded, randomised two cohorts study on the efficacy of two different radiotherapy schedule for DIPG by using the same concomitant and post-radiotherapy systemic treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Intrinsic Pontine Glioma | Diffuse Intrinsic Pontine Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
| Radiotherapy | Other | — | UNRESOLVED |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Standard treatment
- description
- Nimotuzumab 150 mg /mq/d as iv weekly and Vinorelbine 20 mg/mq/d weekly, in week 1-12 (Induction phase).If not progression Nimotuzumab 150 mg/m2 as iv and Vinorelbine 25 mg/m²/d as iv until progression or maximum at week 108; in case of non-progressive disease re-irradiation 1 for a total of 19.8 Gy from week 26 to week 28; in case of non-progressive disease: re-irradiation 2 for a total of 19.8 Gy from week 46 to week 48. Irradiation will be scheduled to begin in the 3rd week after starting the nimotuzumab and vinorelbine treatment. For the first course, a total dose of 36 Gy will be delivered, in 1.8 Gy daily fractions 5 days a week.
- interventionNames
- Drug: Nimotuzumab
- Drug: Vinorelbine
- Other: Radiotherapy
- type
- EXPERIMENTAL
- label
- Experimental treatment
- description
- Nimotuzumab 150 mg /mq/d as iv weekly and Vinorelbine 20 mg/mq/d weekly, in week 1-12 (Induction phase).If not progression Nimotuzumab 150 mg/m2 as iv and Vinorelbine 25 mg/m²/d as iv until progression or maximum at week 108; in case of non-progressive disease re-irradiation 1 for a total of 19.8 Gy from week 26 to week 28; in case of non-progressive disease: re-irradiation 2 for a total of 19.8 Gy from week 46 to week 48. Irradiation will be scheduled to begin in the 3rd week after starting the nimotuzumab and vinorelbine treatment. For the first course, a total dose of 36 Gy will be delivered, in 1.8 Gy daily fractions 5 days a week.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients from 2 to 21 years old will be eligible * No previous treatment consented apart from steroids * Strict eligibility criteria will radiologically-verified DIPG (an intrinsic, pontine-based infiltrative lesion hypointense on T1- and hyperintense on T2-weighted sequences, involving at least 2/3 of the pons) * symptoms lasting less than 6 months, life expectancy ≥4 weeks; Karnowski/Lansky performance status ≥ 40 % * no organ dysfunction; no pregnancy or breast-feeding * Patients undergo baseline cranial MRI with gadolinium, to be repeated if treatment begins more than 2 weeks; spinal MRI due to the occurrence of metastatic cases at diagnosis will also be mandatory * Written and signed informed consent from parents or legal guardians will be obtained before starting the treatment. Exclusion Criteria: * Patients below 2 years or over 21 * Pre-treatment with radio or chemotherapy * Neurofibromatosis 1 * Non-typical imaging * Symptoms duration over 6 months, Lansky/Karnowski scores below 40% * Metastatic disease as shown by MRI * Organ dysfunction, pregnancy or breast-feeding * Absence of parents, patient or tutor consent
References
Publications (53)
- BACKGROUNDBode U, Buchen S, Warmuth-Metz M, Pietsch T, Bach F, Fleischhack G. Final report of a phase II trial of nimotuzumab in the treatment of refractory and relapsed high-grade gliomas in children and adolescents [abstract]. J Clin Oncol (2007); 25(Suppl. 2006)
- RESULTBartels U, Wolff J, Gore L, Dunkel I, Gilheeney S, Allen J, Goldman S, Yalon M, Packer RJ, Korones DN, Smith A, Cohen K, Kuttesch J, Strother D, Baruchel S, Gammon J, Kowalski M, Bouffet E. Phase 2 study of safety and efficacy of nimotuzumab in pediatric patients with progressive diffuse intrinsic pontine glioma. Neuro Oncol. 2014 Nov;16(11):1554-9. doi: 10.1093/neuonc/nou091. Epub 2014 May 20. PMID 24847085
- RESULTBernier-Chastagner V, Grill J, Doz F, Bracard S, Gentet JC, Marie-Cardine A, Luporsi E, Margueritte G, Lejars O, Laithier V, Mechinaud F, Millot F, Kalifa C, Chastagner P. Topotecan as a radiosensitizer in the treatment of children with malignant diffuse brainstem gliomas: results of a French Society of Paediatric Oncology Phase II Study. Cancer. 2005 Dec 15;104(12):2792-7. doi: 10.1002/cncr.21534. PMID 16265674
- RESULTBode U, Massimino M, Bach F, Zimmermann M, Khuhlaeva E, Westphal M, Fleischhack G. Nimotuzumab treatment of malignant gliomas. Expert Opin Biol Ther. 2012 Dec;12(12):1649-59. doi: 10.1517/14712598.2012.733367. Epub 2012 Oct 8. PMID 23043252
- RESULTClerk-Lamalice O, Reddick WE, Li X, Li Y, Edwards A, Glass JO, Patay Z. MRI Evaluation of Non-Necrotic T2-Hyperintense Foci in Pediatric Diffuse Intrinsic Pontine Glioma. AJNR Am J Neuroradiol. 2016 Oct;37(10):1930-1937. doi: 10.3174/ajnr.A4814. Epub 2016 May 19. PMID 27197987
- RESULTConway AE, Reddick WE, Li Y, Yuan Y, Glass JO, Baker JN, Kun LE, Broniscer A, Patay Z. "Occult" post-contrast signal enhancement in pediatric diffuse intrinsic pontine glioma is the MRI marker of angiogenesis? Neuroradiology. 2014 May;56(5):405-12. doi: 10.1007/s00234-014-1348-9. Epub 2014 Mar 14. PMID 24626721