Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma
NCT ID: NCT00939965
Last Updated: 2013-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
75 participants
INTERVENTIONAL
2009-02-28
Brief Summary
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PURPOSE: This clinical trial is studying the side effects and best dose of isotretinoin in treating young patients with high-risk neuroblastoma.
Detailed Description
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Primary
* To investigate the feasibility of implementing individualized dosing of isotretinoin in patients with high-risk neuroblastoma after course 1 of treatment, based on isotretinoin pharmacokinetics and toxicity.
* To minimize the large inter-patient variation in plasma concentrations of isotretinoin.
* To ensure that patients are not exposed to potentially sub-optimal plasma concentrations of isotretinoin during long-term treatment, particularly for patients who are not able to swallow isotretinoin capsules.
Secondary
* To obtain preliminary data on the potential impact of isotretinoin therapeutic monitoring on clinical response and toxicity in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral isotretinoin twice daily on days 1-14. Courses repeat every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and during courses 1-3 for pharmacokinetic studies and determination of each patient's individual therapeutic-dose level requirement. Genotyping to identify genes that metabolize enzymes is conducted via PCR.
After completion of study therapy, patients are followed up periodically for up to 3 years.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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isotretinoin
DNA analysis
polymerase chain reaction
laboratory biomarker analysis
pharmacological study
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed high-risk neuroblastoma
* Concurrent isotretinoin as part of clinical treatment
PATIENT CHARACTERISTICS:
* Not pregnant
* Fertile patients must use effective contraception
* Has a single- or double-lumen central venous catheter in place
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Gareth Veal
Role: PRINCIPAL_INVESTIGATOR
University of Newcastle Upon-Tyne
Locations
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Great Ormond Street Hospital for Children
London, England, United Kingdom
University of Newcastle-Upon-Tyne Northern Institute for Cancer Research
Newcastle upon Tyne, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Countries
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Facility Contacts
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Penelope Brock, MD, PhD
Role: primary
Gareth Veal
Role: primary
Andrew David J. Pearson, MD, FRCP, DCh
Role: primary
Other Identifiers
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CDR0000637053
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20914
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2008-003606-33
Identifier Type: -
Identifier Source: secondary_id
CCLG-PK-2008-03
Identifier Type: -
Identifier Source: org_study_id