Chemotherapeutic Agent ToxicityNCT00514345
CYP3A5 Gene as a Risk Factor for Kidney Damage in Young Patients With Cancer Treated With Ifosfamide
An observational study of Chemotherapeutic Agent Toxicity and Sarcoma, run by Children's Cancer and Leukaemia Group at 21 sites in 2 countries.
Trial summary
RATIONALE: Studying the genes expressed in samples of blood from young patients with cancer treated with ifosfamide may help doctors identify risk factors for kidney damage. PURPOSE: This clinical trial is looking at the CYP3A5 gene to see if having the gene may be a risk factor for kidney damage in young patients… Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Chemotherapeutic Agent Toxicity, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- gene expression analysis, polymorphism analysis and management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Jul 2007to not given
- Phase
- Observational
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Received ifosfamide before the age of 21 as part of treatment for cancer including, but not limited to, any of the following:
- Ewing sarcoma
- Rhabdomyosarcoma
- Non-rhabdomyosarcoma soft tissue sarcoma
- No renal infiltration by tumor at any stage of illness
- May have been treated on one of the following clinical trials:
- Euro-Ewing-Intergroup-EE99
- SIOP-MMT-95
- Patients who received CEV chemotherapy (carboplatin, epirubicin, and vincristine) on strategy 952 or 953 are not eligible
- CCLG-EPSSG-NRSTS-2005
- CCLG-EPSSG-RMS-2005
PATIENT CHARACTERISTICS:
- Clinically stable to undergo renal investigations
- No pre-existing renal impairment (glomerular or tubular) prior to treatment with ifosfamide
- No known nephrotoxicity for which nephrotoxic supportive treatment (aminoglycosides, amphotericin, acyclovir, cyclosporine, or tacrolimus) was a major contributory cause of renal damage
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from the acute non-renal toxicity of the last course of chemotherapy
- No other prior nephrotoxic chemotherapy (e.g., cisplatin, carboplatin, melphalan, or high-dose methotrexate)
- No prior radiotherapy to a field including the kidneys
- No prior removal of renal tissue
- No concurrent ifosfamide
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United Kingdom20 sites, 20 recruiting
- Recruiting
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, AB25 2ZG
Veronica Neefjes, 44-1224-550-217
- Recruiting
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, BT12 6BE
Anthony McCarthy, MD, 44-289-063-3631, anthonymcarthy@royalhospital.n.i.nhs.uk
- Recruiting
Birmingham Children's Hospital
Birmingham, England, B4 6NH
Martin W. English, MD, 44-121-333-8412, martin.english@bch.nhs.uk
- Recruiting
Bristol Royal Hospital for Children
Bristol, England, BS2 8BJ
Contact Person, 44-117-342-0205
- Recruiting
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Amos Burke, MD, 44-1223-348-151
- Recruiting
Childrens Hospital for Wales
Cardiff, Wales, CF14 4XW
Heidi Traunecker, MD, PhD, 44-29-2074-2285, heidi.traunecker@cardiffandvale.wales.nhs.uk
- Recruiting
Royal Hospital for Sick Children
Edinburgh, Scotland, EH9 1LF
W. Hamish Wallace, MD, 44-131-536-0426
- Recruiting
Royal Hospital for Sick Children
Glasgow, Scotland, G3 8SJ
Milind D. Ronghe, MD, 44-141-201-9309
- Recruiting
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Adam Glaser, MD, 44-113-206-4984, adam.glaser@leedsth.nhs.uk
- Recruiting
Leicester Royal Infirmary
Leicester, England, LE1 5WW
Johann Visser, MD, 44-116-258-5309, johannes.visser@uhl-tr.nhs.uk
- Recruiting
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, L12 2AP
Heather P. McDowell, MD, 44-151-293-3679
- Recruiting
University College Hospital
London, England, NW1 2PCE
Maria Michelagnoli, MD, 44-20-7380-9064, maria.michelagnoli@uclh.nhs.uk
- Recruiting
Great Ormond Street Hospital for Children
London, England, WC1N 3JH
Gill Levitt, MD, 44-20-7405-9200 ext. 0073
- Recruiting
Royal Manchester Children's Hospital
Manchester, England, M27 4HA
Bernadette Brennan, MD, 44-161-922-2227, bernadette.brennan@cmmc.nhs.uk
- Recruiting
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, NE1 4LP
Juliet Hale, MD, 44-191-282-4101, j.p.hale@ncl.ac.uk
- Recruiting
Queen's Medical Centre
Nottingham, England, NG7 2UH
Martin Hewitt, MD, BSc, FRCP, FRCPCH, 44-115-924-9924 ext. 63394, martin.hewitt@nuh.nhs.uk
- Recruiting
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
Kate Wheeler, MD, 44-186-522-1066
- Recruiting
Children's Hospital - Sheffield
Sheffield, England, S10 2TH
Mary P. Gerrard, MBChB, FRCP, FRCPCH, 44-114-271-7366, mary.gerrard@sch.nhs.uk
- Recruiting
Southampton General Hospital
Southampton, England, SO16 6YD
Janice A. Kohler, MD, FRCP, 44-23-8079-6942
- Recruiting
Royal Marsden - Surrey
Sutton, England, SM2 5PT
Mary Taj, MD, 44-20-8642-6011 ext. 3089
Ireland1 site, 1 recruiting
- Recruiting
Our Lady's Hospital for Sick Children Crumlin
Dublin, 12
Contact Person, 353-1-409-6659
About this study
Official title: CYP3A5 Genotype as a Potential Risk Factor for the Development of Ifosamide Nephrotoxicity in Children
RATIONALE: Studying the genes expressed in samples of blood from young patients with cancer treated with ifosfamide may help doctors identify risk factors for kidney damage.
PURPOSE: This clinical trial is looking at the CYP3A5 gene to see if having the gene may be a risk factor for kidney damage in young patients with cancer treated with ifosfamide.
Read the detailed description
OBJECTIVES:
Primary
- To determine the CYP3A5 genotype in young patients with cancer who have received ifosfamide.
- To document renal function and nephrotoxicity on one occasion between 1 month and 5 years after completion of ifosfamide treatment.
- To determine the relationship between CYP3A5 genotype and ifosfamide nephrotoxicity.
Secondary
- To compare the measured glomerular filtration rate (GFR) (using a radioisotope clearance method) with that calculated using the Cole (weight and creatinine) model.
OUTLINE: This is a multicenter study.
Nephrotoxicity assessment is performed in patients who have not undergone prior assessment*.
NOTE: *Nephrotoxicity assessment is performed once between 1 month and 5 years after completion of ifosfamide chemotherapy.
All patients will undergo a single blood sample collection. DNA will be extracted from this sample and genotyped for the known functional polymorphisms in CYP3A5. The technique of restriction fragment length polymorphism (RFLP) will be used to detect any single nucleotide polymorphisms in CYP3A5.
DNA may be obtained from stored tumor samples from patients for whom the results of renal investigations are available, but for whom blood is not available for CYP3A5 genotyping.
- Conditions
- Chemotherapeutic Agent Toxicity, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific
- Being tested
- gene expression analysis, polymorphism analysis, management of therapy complications
- Keywords
- chemotherapeutic agent toxicity, localized Ewing sarcoma/peripheral primitive neuroectodermal tumor, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, nonmetastatic childhood soft tissue sarcoma, unspecified childhood solid tumor, protocol specific, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, previously treated childhood rhabdomyosarcoma, recurrent childhood rhabdomyosarcoma
- Medical subject headings
- Sarcoma, Neuroectodermal Tumors, Primitive, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
polymorphism analysisGenetic
management of therapy complicationsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
CYP3A5 genotype
Renal function and nephrotoxicity
Relationship between CYP3A5 genotype and ifosfamide nephrotoxicity
Secondary outcomes (1)
Comparison of measured glomerular filtration rate (GFR) with the Cole model
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapeutic Agent ToxicityStudies 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
- Observational
- Enrolment
- 300 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
- NCT00514345
- Sponsor's protocol ID
- CCLG-PK-2007-02
- Other IDs
- CDR0000560128, EU-20743
- Status last verified
- Jun 2009
- First submitted
- 8 Aug 2007
- 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
- CYP3A5 Genotype as a Potential Risk Factor for the Development of Ifosamide Nephrotoxicity in Children
- ClinicalTrials.gov ID
- NCT00514345
- Acronym / sponsor ID
- CCLG-PK-2007-02
- Conditions
- Chemotherapeutic Agent Toxicity, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific
- Keywords
- chemotherapeutic agent toxicity, localized Ewing sarcoma/peripheral primitive neuroectodermal tumor, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, nonmetastatic childhood soft tissue sarcoma, unspecified childhood solid tumor, protocol specific, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Children's Cancer and Leukaemia GroupUniversity, hospital or other
- Study start
- Jul 2007
- First posted
- 9 Aug 2007 (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 the genes expressed in samples of blood from young patients with cancer treated with ifosfamide may help doctors identify risk factors for kidney damage.
PURPOSE: This clinical trial is looking at the CYP3A5 gene to see if having the gene may be a risk factor for kidney damage in young patients with cancer treated with ifosfamide.
Detailed description
OBJECTIVES:
Primary
- To determine the CYP3A5 genotype in young patients with cancer who have received ifosfamide.
- To document renal function and nephrotoxicity on one occasion between 1 month and 5 years after completion of ifosfamide treatment.
- To determine the relationship between CYP3A5 genotype and ifosfamide nephrotoxicity.
Secondary
- To compare the measured glomerular filtration rate (GFR) (using a radioisotope clearance method) with that calculated using the Cole (weight and creatinine) model.
OUTLINE: This is a multicenter study.
Nephrotoxicity assessment is performed in patients who have not undergone prior assessment*.
NOTE: *Nephrotoxicity assessment is performed once between 1 month and 5 years after completion of ifosfamide chemotherapy.
All patients will undergo a single blood sample collection. DNA will be extracted from this sample and genotyped for the known functional polymorphisms in CYP3A5. The technique of restriction fragment length polymorphism (RFLP) will be used to detect any single nucleotide polymorphisms in CYP3A5.
DNA may be obtained from stored tumor samples from patients for whom the results of renal investigations are available, but for whom blood is not available for CYP3A5 genotyping.
Study design
Who may qualify
- Ages
- Up to 20 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 |
|---|---|---|
| gene expression analysis | Genetic | – |
| polymorphism analysis | Genetic | – |
| management of therapy complications | Procedure or surgery | – |
Primary outcome
CYP3A5 genotype
Renal function and nephrotoxicity
Relationship between CYP3A5 genotype and ifosfamide nephrotoxicity
1 secondary outcome
Comparison of measured glomerular filtration rate (GFR) with the Cole model
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.
Gareth Veal principal investigator
University of Newcastle Upon-Tyne
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapeutic Agent Toxicity and Sarcoma, run by Children's Cancer and Leukaemia Group at 21 sites in 2 countries.
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 21 sites in United Kingdom, Ireland. 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?
CYP3A5 genotype. The study lists 3 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.