NeuroblastomaNCT00939965
Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma
A study testing isotretinoin, DNA analysis and polymerase chain reaction in people with Neuroblastoma, run by Children's Cancer and Leukaemia Group at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- isotretinoin, DNA analysis and polymerase chain reaction
- How many people
- 75 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Feb 2009to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
Great Ormond Street Hospital for Children
London, England, WC1N 3JH
Penelope Brock, MD, PhD, 44-20-7829-7924, Brockp@gosh.nhs.uk
- Recruiting
University of Newcastle-Upon-Tyne Northern Institute for Cancer Research
Newcastle upon Tyne, England, NE2 4HH
Gareth Veal, 44-191-246-4332
- Recruiting
Royal Marsden - Surrey
Sutton, England, SM2 5PT
Andrew David J. Pearson, MD, FRCP, DCh, 44-208-661-3163
About this study
Official title: Pilot Study to Investigate the Feasibility of 13-cis-retinoic Acid Pharmacokinetic Monitoring in High-risk Neuroblastoma Patients
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.
Read the 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.
- Conditions
- Neuroblastoma
- Being tested
- isotretinoin, DNA analysis, polymerase chain reaction, laboratory biomarker analysis, pharmacological study
- Keywords
- localized unresectable neuroblastoma, recurrent neuroblastoma, stage 4S neuroblastoma
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isotretinoinDrug
DNA analysisGenetic
polymerase chain reactionGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of isotretinoin
Toxicity according to NCI CTCAE v.3
Secondary outcomes (1)
Clinical response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer and Leukaemia Group
- Sponsor type
- University, hospital or other
- Investigators
- Gareth Veal, Principal investigator, University of Newcastle Upon-Tyne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939965
- Sponsor's protocol ID
- CCLG-PK-2008-03
- Other IDs
- CDR0000637053, EU-20914, EUDRACT-2008-003606-33
- Status last verified
- Jul 2009
- First submitted
- 14 Jul 2009
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate the Feasibility of 13-cis-retinoic Acid Pharmacokinetic Monitoring in High-risk Neuroblastoma Patients
- ClinicalTrials.gov ID
- NCT00939965
- Acronym / sponsor ID
- CCLG-PK-2008-03
- Conditions
- Neuroblastoma
- Keywords
- localized unresectable neuroblastoma, recurrent neuroblastoma, stage 4S neuroblastoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Children's Cancer and Leukaemia GroupUniversity, hospital or other
- Study start
- Feb 2009
- First posted
- 15 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isotretinoin | Drug | – |
| DNA analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| laboratory biomarker analysis | Other | – |
| pharmacological study | Other | – |
Primary outcome
Pharmacokinetics of isotretinoin
Toxicity according to NCI CTCAE v.3
1 secondary outcome
Clinical response
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
University of Newcastle-Upon-Tyne Northern Institute for Cancer Research
Newcastle upon Tyne, United Kingdom
Gareth Veal principal investigator
University of Newcastle Upon-Tyne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isotretinoin, DNA analysis and polymerase chain reaction in people with Neuroblastoma, run by Children's Cancer and Leukaemia Group at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of isotretinoin. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.