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Irinotecan in Combination With Cisplatin in Pediatric Patients With Unfavorable Prognosis Gliomas

NCT01574092 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2015-08-24

No results posted yet for this study

Summary

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

  • Pediatric High Risk Gliomas

Interventions

DRUG

Combination of two marketed drugs (irinotecan and cisplatin)

Irinotecan 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.

Sponsors & Collaborators

  • Fundació Sant Joan de Déu

    collaborator OTHER

  • Spanish National Health System

    collaborator OTHER

  • Hospital Sant Joan de Deu

    lead OTHER

Principal Investigators

  • OFELIA CRUZ, MD, PhD · HOSPITAL DE SANT JOAN DE DÈU

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2014-06-30
Completion
2015-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01574092 on ClinicalTrials.gov