Clinical trial · Interventional
Irinotecan in Combination With Cisplatin in Pediatric Patients With Unfavorable Prognosis Gliomas
Phase II, Single Arm, Open Label Clinical Trial With Irinotecan in Combination With Cisplatin in Pediatric Patients With Unfavorable Prognosis Gliomas
NCT01574092CI-TRIAL-00018922completedPhase 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)
Tumours of the brain and of the central nervous system (CNS) are the most common solid tumours in children. Amongst these, gliomas are the most frequent, although this term covers different histological subtypes, the most frequent being astrocytoma. However, they are rare diseases of low prevalence. The interest in the cisplatin/irinotecan combination in brain tumours motivated a previous pilot study at our hospital, with encouraging results. This experience, together with the need for new strategies for high-risk pediatric gliomas has motivated the conduct of this study.
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 |
|---|---|---|---|
| Pediatric High Risk Gliomas | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combination of two marketed drugs (irinotecan and cisplatin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Irinotecan plus Cisplatin combination
- description
- This is a open-label study with only one treatment experimental arm. The patients will be treated, in a weekly basis, with 30 mg/m2 of cisplatino plus 65 mg/m2 of irinotecán (one cycle), until a total of 16 cycles.
- interventionNames
- Drug: Combination of two marketed drugs (irinotecan and cisplatin)
Primary outcomes (1)
- measure
- The primary objective of this study is to determine the safety and objective response rate (ORR).
- timeFrame
- Clinical signs, AEs, SAEs, ARs, SARs, Imaging and Audiometry changes: from baseline to FUP month 12.
- description
- The primary objective is to determine the safety and objective response rate (ORR), defined according to the criteria given in the CPMP/EWP/205/95/Rev.3/Corr.2, of irinotecan + cisplatin in pediatric patients with gliomas, through clinical signs and MR. The primary variable is the ORR.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 1. Histological confirmation of neoplasia, except for intrinsic brain stem tumour and optic pathway glioma in one patient with neurofibromatosis type 1 (NF1). 2. Pertaining to one of the diagnostic groups: Cohort 1: Recently diagnosed high grade glioma. Cohort 2: Recurrent high grade glioma. Cohort 3: Intrinsic brain stem tumour. Cohort 4: High risk low grade glioma. 3. Measurable primary or metastatic tumours with at least one 10 mm diameter lesion in two MR dimensions. 4. Absence of prior treatment with cisplatin or irinotecan. 5. Aged between 6 months to 18 years. 6. Lansky/Karnofsky performance status ≥ 70% (Appendix 6.1). Neurological deficits secondary to the tumour should be stable before entering the trial. 7. Patients receiving dexamethasone should be on a stable or decreasing regimen before inclusion. 8. Life expectancy ≥ 3 months. 9. Adequate organic function, including haematological, renal and hepatic function. 10. Wash-out period of at least 3 weeks after chemotherapy and 6 weeks after nitrosoureas or radiotherapy. Recovery from all toxic effects of previous treatments. 11. Subjects of fertile age should use an effective birth control method throughout the entire study. Women of child-bearing age will be included after a negative pregnancy test result. 12. Informed consent of the parents or legal representative, and informed consent of the mature minor. Exclusion criteria: 1. Concurrent administration of any other anti-cancer treatment. 2. Pre-existing, non-controlled diarrhoea 3. Pregnancy or lactation 4. Treatment in another clinical trial. 5. Serious concomitant disease that could compromise the completion of the trial. -
References
Publications (23)
- BACKGROUNDAlonso M, Hamelin R, Kim M, Porwancher K, Sung T, Parhar P, Miller DC, Newcomb EW. Microsatellite instability occurs in distinct subtypes of pediatric but not adult central nervous system tumors. Cancer Res. 2001 Mar 1;61(5):2124-8. PMID 11280776
- BACKGROUNDBlaney S, Berg SL, Pratt C, Weitman S, Sullivan J, Luchtman-Jones L, Bernstein M. A phase I study of irinotecan in pediatric patients: a pediatric oncology group study. Clin Cancer Res. 2001 Jan;7(1):32-7. PMID 11205914
- BACKGROUNDBomgaars L, Berg SL, Blaney SM. The development of camptothecin analogs in childhood cancers. Oncologist. 2001;6(6):506-16. doi: 10.1634/theoncologist.6-6-506. PMID 11743213
- BACKGROUNDBomgaars L, Kerr J, Berg S, Kuttesch J, Klenke R, Blaney SM. A phase I study of irinotecan administered on a weekly schedule in pediatric patients. Pediatr Blood Cancer. 2006 Jan;46(1):50-5. doi: 10.1002/pbc.20355. PMID 15768380
- BACKGROUNDBomgaars LR, Bernstein M, Krailo M, Kadota R, Das S, Chen Z, Adamson PC, Blaney SM. Phase II trial of irinotecan in children with refractory solid tumors: a Children's Oncology Group Study. J Clin Oncol. 2007 Oct 10;25(29):4622-7. doi: 10.1200/JCO.2007.11.6103. PMID 17925558
- BACKGROUNDBouffet E, Mottolese C, Jouvet A, Philip I, Frappaz D, Carrie C, Brunat-Mentigny M. Etoposide and thiotepa followed by ABMT (autologous bone marrow transplantation) in children and young adults with high-grade gliomas. Eur J Cancer. 1997 Jan;33(1):91-5. doi: 10.1016/s0959-8049(96)00369-3. PMID 9071906
- BACKGROUNDBrat DJ, Shehata BM, Castellano-Sanchez AA, Hawkins C, Yost RB, Greco C, Mazewski C, Janss A, Ohgaki H, Perry A. Congenital glioblastoma: a clinicopathologic and genetic analysis. Brain Pathol. 2007 Jul;17(3):276-81. doi: 10.1111/j.1750-3639.2007.00071.x. Epub 2007 Apr 23.