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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)

Brief Summary:

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.


Condition or disease Intervention/treatment
Neuroblastoma Drug: isotretinoin Genetic: DNA analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis Other: pharmacological study

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Investigate the Feasibility of 13-cis-retinoic Acid Pharmacokinetic Monitoring in High-risk Neuroblastoma Patients
Study Start Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma
U.S. FDA Resources




Primary Outcome Measures :
  1. Pharmacokinetics of isotretinoin
  2. Toxicity according to NCI CTCAE v.3

Secondary Outcome Measures :
  1. Clinical response


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939965


Locations
United Kingdom
Great Ormond Street Hospital for Children Recruiting
London, England, United Kingdom, WC1N 3JH
Contact: Penelope Brock, MD, PhD    44-20-7829-7924    Brockp@gosh.nhs.uk   
University of Newcastle-Upon-Tyne Northern Institute for Cancer Research Recruiting
Newcastle-Upon-Tyne, England, United Kingdom, NE2 4HH
Contact: Gareth Veal    44-191-246-4332      
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Andrew David J. Pearson, MD, FRCP, DCh    44-208-661-3163      
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
Principal Investigator: Gareth Veal University of Newcastle Upon-Tyne

ClinicalTrials.gov Identifier: NCT00939965     History of Changes
Other Study ID Numbers: CCLG-PK-2008-03
CDR0000637053 ( Registry Identifier: PDQ (Physician Data Query) )
EU-20914
EUDRACT-2008-003606-33
First Posted: July 15, 2009    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
localized unresectable neuroblastoma
recurrent neuroblastoma
stage 4S neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Isotretinoin
Dermatologic Agents