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Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma

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ClinicalTrials.gov Identifier: NCT00939965
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : July 15, 2009
Last Update Posted : August 12, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

July 14, 2009
July 15, 2009
August 12, 2013
February 2009
Not Provided
  • Pharmacokinetics of isotretinoin
  • Toxicity according to NCI CTCAE v.3
Same as current
Complete list of historical versions of study NCT00939965 on ClinicalTrials.gov Archive Site
Clinical response
Same as current
Not Provided
Not Provided
 
Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma
Pilot Study to Investigate the Feasibility of 13-cis-retinoic Acid Pharmacokinetic Monitoring in High-risk Neuroblastoma Patients

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors plan better treatment for patients receiving isotretinoin.

PURPOSE: This clinical trial is studying the side effects and best dose of isotretinoin in treating young patients with high-risk neuroblastoma.

OBJECTIVES:

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.

Interventional
Not Applicable
Masking: None (Open Label)
Primary Purpose: Treatment
Neuroblastoma
  • Drug: isotretinoin
  • Genetic: DNA analysis
  • Genetic: polymerase chain reaction
  • Other: laboratory biomarker analysis
  • Other: pharmacological study
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
75
Same as current
Not Provided
Not Provided

DISEASE CHARACTERISTICS:

  • 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
Sexes Eligible for Study: All
up to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00939965
CCLG-PK-2008-03
CDR0000637053 ( Registry Identifier: PDQ (Physician Data Query) )
EU-20914
EUDRACT-2008-003606-33
Not Provided
Not Provided
Not Provided
Not Provided
Children's Cancer and Leukaemia Group
Not Provided
Principal Investigator: Gareth Veal University of Newcastle Upon-Tyne
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP