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Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00939965
First Posted: July 15, 2009
Last Update Posted: August 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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 Intervention
Neuroblastoma Drug: isotretinoin Genetic: DNA analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis Other: pharmacological study

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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

Secondary Outcome Measures:
  • Clinical response

Estimated Enrollment: 75
Study Start Date: February 2009
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: July 14, 2009
First Posted: July 15, 2009
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