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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Sant Joan de Deu
• Collaborators: Fundació Sant Joan de Déu; Spanish National Health System
• Treatments: Camptothecin; Cisplatin; Irinotecan

Criteria

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. -