Irinotecan in Combination With Cisplatin in Pediatric Patients With Unfavorable Prognosis Gliomas
- Sponsor
- Hospital Sant Joan de Deu
- Study ID
- NCT01574092
- Phase
- PHASE2
- Status
- Completed
Conditions
- Pediatric High Risk Gliomas
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Months - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- Combination of two marketed drugs (irinotecan and cisplatin) — DRUGIrinotecan and Cisplatin will be administered weekly ambulatory, intravenous (iv), until to reach a total of 16 cycles. Cisplatin is administered first and then Irinotecan. Cisplatin 30 mg/m2/d (iv) in one hour,followed by Irinotecan 65 mg/m2/d iv in one hour. There is a one-week rest period every 4 cycles. The total treatment length including 16 cycles + rest weeks is 19 weeks.
Study Details
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.
Key Dates
- Start date
- Nov 30, 2009
- Status verified
- Aug 2015
- Primary completion
- Jun 30, 2014
- Completion
- Mar 31, 2015
Study Design
- Enrollment
- 39 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Irinotecan plus Cisplatin combinationThis 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.
Primary Outcome Measure
The primary objective of this study is to determine the safety and objective response rate (ORR). [ Time Frame: Clinical signs, AEs, SAEs, ARs, SARs, Imaging and Audiometry changes: from baseline to FUP month 12. ]