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Study of CYP3A5 Genotype as a Potential Risk Factor for the Development of Ifosfamide Nephrotoxicity in Young Patients With Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information
Alternate Title
CYP3A5 Gene as a Risk Factor for Kidney Damage in Young Patients With Cancer Treated With Ifosfamide
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| No phase specified | Biomarker/Laboratory analysis, Natural history/Epidemiology | Active | Under 21 | CCLG-PK-2007-02
PK 2007 02, EU-20743, NCT00514345 |
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.
Entry Criteria 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:
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
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
Expected Enrollment 300Outcomes Primary Outcome(s)CYP3A5 genotype
Renal function and nephrotoxicity
Relationship between CYP3A5 genotype and ifosfamide
nephrotoxicity
Secondary Outcome(s)Comparison of measured glomerular filtration rate (GFR) with the Cole 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.
Trial Contact Information
Trial Lead Organizations Children's Cancer and Leukaemia Group | | | | Gareth Veal, Principal investigator | | | |
Trial Sites
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| Ireland |
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Dublin |
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| | | | Our Lady's Hospital for Sick Children Crumlin |
| | | Contact Person | |
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| United Kingdom |
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| England |
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Birmingham |
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| | | | | Birmingham Children's Hospital |
| | | Martin English, MD | |
| | Email:
martin.english@bch.nhs.uk |
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Bristol |
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| | | Bristol Royal Hospital for Children |
| | | Contact Person | |
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Cambridge |
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| | | Addenbrooke's Hospital |
| | | Amos Burke, MD | |
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Leeds |
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| | | Leeds Cancer Centre at St. James's University Hospital |
| | | Adam Glaser, MD | |
| | Email:
adam.glaser@leedsth.nhs.uk |
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Leicester |
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| | | Leicester Royal Infirmary |
| | | Johann Visser, MD | |
| | Email:
johannes.visser@uhl-tr.nhs.uk |
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Liverpool |
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| | | Royal Liverpool Children's Hospital, Alder Hey |
| | | Heather McDowell, MD | |
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London |
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| | | Great Ormond Street Hospital for Children |
| | | Gill Levitt, MD | | Ph: | 44-20-7405-9200 ext. 0073 | | |
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| | | University College Hospital |
| | | Maria Michelagnoli, MD | |
| | Email:
maria.michelagnoli@uclh.nhs.uk |
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Manchester |
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| | | Royal Manchester Children's Hospital |
| | | Bernadette Brennan, MD | |
| | Email:
bernadette.brennan@cmmc.nhs.uk |
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Newcastle-Upon-Tyne |
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| | | Sir James Spence Institute of Child Health at Royal Victoria Infirmary |
| | | Juliet Hale, MD | |
| | Email:
j.p.hale@ncl.ac.uk |
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Nottingham |
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| | | Queen's Medical Centre |
| | | Martin Hewitt, MD, BSc, FRCP, FRCPCH | | Ph: | 44-115-924-9924 ext. 63394 | | |
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| | Email:
martin.hewitt@nuh.nhs.uk |
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Oxford |
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| | | Oxford Radcliffe Hospital |
| | | Kate Wheeler, MD | |
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Sheffield |
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| | | Children's Hospital - Sheffield |
| | | Mary Gerrard, MBChB, FRCP, FRCPCH | |
| | Email:
mary.gerrard@sch.nhs.uk |
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Southampton |
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| | | Southampton General Hospital |
| | | Janice Kohler, MD, FRCP | |
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Sutton |
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| | | Royal Marsden - Surrey |
| | | Mary Taj, MD | | Ph: | 44-20-8642-6011 ext. 3089 | | |
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| Northern Ireland |
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Belfast |
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| | | | Royal Belfast Hospital for Sick Children |
| | | Anthony McCarthy, MD | |
| | Email:
anthonymcarthy@royalhospital.n.i.nhs.uk |
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| Scotland |
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Aberdeen |
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| | | | Royal Aberdeen Children's Hospital |
| | | Veronica Neefjes | |
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Edinburgh |
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| | | Royal Hospital for Sick Children |
| | | W. Hamish Wallace, MD | |
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Glasgow |
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| | | Royal Hospital for Sick Children |
| | | Milind Ronghe, MD | |
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| Wales |
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Cardiff |
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| | | | Childrens Hospital for Wales |
| | | Heidi Traunecker, MD, PhD | |
| | Email:
heidi.traunecker@cardiffandvale.wales.nhs.uk |
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Related Information PDQ® clinical trial EURO-EWING-INTERGROUP-EE99
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PDQ® clinical trial CCLG-EPSSG-NRSTS-2005
| Registry Information | | | Official Title | | CYP3A5 Genotype as a Potential Risk Factor for the Development of Ifosamide Nephrotoxicity in Children | | | Trial Start Date | | 2007-07-01 | | | Registered in ClinicalTrials.gov | | NCT00514345 | | | Date Submitted to PDQ | | 2007-07-16 | | | Information Last Verified | | 2009-06-14 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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