Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma

Neuroblastoma Clinical Trial

Official title:

Pilot Study to Investigate the Feasibility of 13-cis-retinoic Acid Pharmacokinetic Monitoring in High-risk Neuroblastoma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00939965
• Other study ID #: CCLG-PK-2008-03
• Secondary ID: CDR0000637053EU-
• Status: Recruiting
• Phase: N/A
• First received: July 14, 2009
• Last updated: August 9, 2013
• Start date: February 2009

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Drug:
• isotretinoin

Genetic:
• DNA analysis

• polymerase chain reaction

Other:
• laboratory biomarker analysis

• pharmacological study

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer and Leukaemia Group

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of isotretinoin			No
Primary	Toxicity according to NCI CTCAE v.3			Yes
Secondary	Clinical response			No