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

NCT01574092 | Completed Phase 2

• 1 other identifier: HSJD-GLIOMAS-IC
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pediatric; Pediatrics; Gliomas; Glioma; Brain tumor; Brain cancer; Cisplatin; Cisplatino; Irinotecan; Brain stem tumor; Brainstem gliomas; Intrinsic brain stem tumor; PAEDIATRIC HIGH GRADE GLIOMA; Childhood brain stem glioma

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to determine the safety and objective response rate (ORR).

  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.

  Clinical signs, AEs, SAEs, ARs, SARs, Imaging and Audiometry changes: from baseline to FUP month 12.

Secondary Outcomes (5)

• Duration of the response.

  Clinical signs: baseline and every week (w1to21)+FUP month 3,6,9,12. Imaging (RM Baseline+w10&20+FUP month 3,6,9,12/PET: Baseline+w20).

• Safety of the combined Irinotecan+Cisplatin therapy

  Clinical signs, AEs, SAEs, ARs, SARs: baseline and every week (w1to21)+FUP month 3,6,9,12.Blood (hemo/chem):baseline&every week (w 1 to 21, except w10). Audiometry: baseline+w20+m6+m12.

• Possible associations of gene MGMT promoter and microsatellites instability with reference to response to study treatment

  Clinical signs: baseline and every week (w1to21)+FUP month 3,6,9,12. Imaging (RM Baseline+w10&20+FUP month 3,6,9,12/PET: Baseline+w20). Genomic study: baseline (week-14 to-9)

• To assess the applicability and efficacy of volumetric measurements as a treatment tumor-response indicator.

  Clinical signs: baseline (day-14to-9) and every week (w1to21)+FUP month 3,6,9,12. Imaging (RM Baseline day-14to -9 +w10&20+FUP month 3,6,9,12.

• To assess the applicability and efficacy of metabolic study by PET-methionine

  Clinical signs: baseline (day-14to-9) and every week (w1to21)+FUP month 3,6,9,12. PET: Baseline day-14to -9 + w20).

Study Arms (1)

Irinotecan plus Cisplatin combination

EXPERIMENTAL

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.

Drug: Combination of two marketed drugs (irinotecan and cisplatin)

Interventions

Combination of two marketed drugs (irinotecan and cisplatin) DRUG

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.

Also known as: Irinotecan Hospira (20mg/ml), Cisplating Ferrer Farma(10mg or 50mg presentations)

Irinotecan plus Cisplatin combination

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Histological confirmation of neoplasia, except for intrinsic brain stem tumour and optic pathway glioma in one patient with neurofibromatosis type 1 (NF1).
• 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.
• Measurable primary or metastatic tumours with at least one 10 mm diameter lesion in two MR dimensions.
• Absence of prior treatment with cisplatin or irinotecan.
• Aged between 6 months to 18 years.
• Lansky/Karnofsky performance status ≥ 70% (Appendix 6.1). Neurological deficits secondary to the tumour should be stable before entering the trial.
• Life expectancy ≥ 3 months.
• Adequate organic function, including haematological, renal and hepatic function.
• 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.
• 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.
• Informed consent of the parents or legal representative, and informed consent of the mature minor.

You may not qualify if:

• Concurrent administration of any other anti-cancer treatment.
• Pre-existing, non-controlled diarrhoea
• Pregnancy or lactation
• Treatment in another clinical trial.
• Serious concomitant disease that could compromise the completion of the trial. -

Sponsors & Collaborators

• Hospital Sant Joan de Deu: lead
• Fundació Sant Joan de Déu: collaborator
• Spanish National Health System: collaborator

Study Sites (1)

Hospital Sant Joan De Déu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Related Publications (23)

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MeSH Terms

Conditions

Glioma; Brain Neoplasms; Brain Stem Neoplasms

Interventions

Irinotecan; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infratentorial Neoplasms

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• OFELIA CRUZ, MD, PhD

  HOSPITAL DE SANT JOAN DE DÈU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 10, 2012
• Study Start: November 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: March 1, 2015
• Last Updated: August 24, 2015

Record last verified: 2015-08

Locations

ES (1)