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Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma

Primary Purpose

Neuroblastoma

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
isotretinoin
DNA analysis
polymerase chain reaction
laboratory biomarker analysis
pharmacological study
Sponsored by
Children's Cancer and Leukaemia Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroblastoma focused on measuring localized unresectable neuroblastoma, recurrent neuroblastoma, stage 4S neuroblastoma

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Great Ormond Street Hospital for ChildrenRecruiting
  • University of Newcastle-Upon-Tyne Northern Institute for Cancer ResearchRecruiting
  • Royal Marsden - SurreyRecruiting

Outcomes

Primary Outcome Measures

Pharmacokinetics of isotretinoin
Toxicity according to NCI CTCAE v.3

Secondary Outcome Measures

Clinical response

Full Information

First Posted
July 14, 2009
Last Updated
August 9, 2013
Sponsor
Children's Cancer and Leukaemia Group
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1. Study Identification

Unique Protocol Identification Number
NCT00939965
Brief Title
Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma
Official Title
Pilot Study to Investigate the Feasibility of 13-cis-retinoic Acid Pharmacokinetic Monitoring in High-risk Neuroblastoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Cancer and Leukaemia Group

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma
Keywords
localized unresectable neuroblastoma, recurrent neuroblastoma, stage 4S neuroblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
isotretinoin
Intervention Type
Genetic
Intervention Name(s)
DNA analysis
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
pharmacological study
Primary Outcome Measure Information:
Title
Pharmacokinetics of isotretinoin
Title
Toxicity according to NCI CTCAE v.3
Secondary Outcome Measure Information:
Title
Clinical response

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gareth Veal
Organizational Affiliation
University of Newcastle Upon-Tyne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Great Ormond Street Hospital for Children
City
London
State/Province
England
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Penelope Brock, MD, PhD
Phone
44-20-7829-7924
Email
Brockp@gosh.nhs.uk
Facility Name
University of Newcastle-Upon-Tyne Northern Institute for Cancer Research
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE2 4HH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gareth Veal
Phone
44-191-246-4332
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew David J. Pearson, MD, FRCP, DCh
Phone
44-208-661-3163

12. IPD Sharing Statement

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Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma

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