NCT00939965

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2009

Completed
Last Updated

August 12, 2013

Status Verified

July 1, 2009

First QC Date

July 14, 2009

Last Update Submit

August 9, 2013

Conditions

Neuroblastoma

Keywords

localized unresectable neuroblastomarecurrent neuroblastomastage 4S neuroblastoma

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics of isotretinoin

  • Toxicity according to NCI CTCAE v.3

Secondary Outcomes (1)

  • Clinical response

Interventions

isotretinoinDRUG
DNA analysisGENETIC
polymerase chain reactionGENETIC
laboratory biomarker analysisOTHER
pharmacological studyOTHER

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Great Ormond Street Hospital for Children

London, England, WC1N 3JH, United Kingdom

RECRUITING

University of Newcastle-Upon-Tyne Northern Institute for Cancer Research

Newcastle upon Tyne, England, NE2 4HH, United Kingdom

RECRUITING

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neuroblastoma

Interventions

IsotretinoinPolymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological FactorsNucleic Acid Amplification TechniquesGenetic TechniquesInvestigative Techniques

Study Officials

  • Gareth Veal

    University of Newcastle Upon-Tyne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 15, 2009

Study Start

February 1, 2009

Last Updated

August 12, 2013

Record last verified: 2009-07

Locations

GB(3)