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CYP3A5 Gene as a Risk Factor for Kidney Damage in Young Patients With Cancer Treated With Ifosfamide

Primary Purpose

Chemotherapeutic Agent Toxicity, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific

Status
Unknown status
Phase
Locations
International
Study Type
Observational
Intervention
gene expression analysis
polymorphism analysis
management of therapy complications
Sponsored by
Children's Cancer and Leukaemia Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Chemotherapeutic Agent Toxicity focused on measuring 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

Eligibility Criteria

undefined - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Our Lady's Hospital for Sick Children CrumlinRecruiting
  • Birmingham Children's HospitalRecruiting
  • Bristol Royal Hospital for ChildrenRecruiting
  • Addenbrooke's HospitalRecruiting
  • Leeds Cancer Centre at St. James's University HospitalRecruiting
  • Leicester Royal InfirmaryRecruiting
  • Royal Liverpool Children's Hospital, Alder HeyRecruiting
  • University College HospitalRecruiting
  • Great Ormond Street Hospital for ChildrenRecruiting
  • Royal Manchester Children's HospitalRecruiting
  • Sir James Spence Institute of Child Health at Royal Victoria InfirmaryRecruiting
  • Queen's Medical CentreRecruiting
  • Oxford Radcliffe HospitalRecruiting
  • Children's Hospital - SheffieldRecruiting
  • Southampton General HospitalRecruiting
  • Royal Marsden - SurreyRecruiting
  • Royal Belfast Hospital for Sick ChildrenRecruiting
  • Royal Aberdeen Children's HospitalRecruiting
  • Royal Hospital for Sick ChildrenRecruiting
  • Royal Hospital for Sick ChildrenRecruiting
  • Childrens Hospital for WalesRecruiting

Outcomes

Primary Outcome Measures

CYP3A5 genotype
Renal function and nephrotoxicity
Relationship between CYP3A5 genotype and ifosfamide nephrotoxicity

Secondary Outcome Measures

Comparison of measured glomerular filtration rate (GFR) with the Cole model

Full Information

First Posted
August 8, 2007
Last Updated
August 9, 2013
Sponsor
Children's Cancer and Leukaemia Group
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1. Study Identification

Unique Protocol Identification Number
NCT00514345
Brief Title
CYP3A5 Gene as a Risk Factor for Kidney Damage in Young Patients With Cancer Treated With Ifosfamide
Official Title
CYP3A5 Genotype as a Potential Risk Factor for the Development of Ifosamide Nephrotoxicity in Children
Study Type
Observational

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2007 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, previously treated childhood rhabdomyosarcoma, recurrent childhood rhabdomyosarcoma

7. Study Design

Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Genetic
Intervention Name(s)
polymorphism analysis
Intervention Type
Procedure
Intervention Name(s)
management of therapy complications
Primary Outcome Measure Information:
Title
CYP3A5 genotype
Title
Renal function and nephrotoxicity
Title
Relationship between CYP3A5 genotype and ifosfamide nephrotoxicity
Secondary Outcome Measure Information:
Title
Comparison of measured glomerular filtration rate (GFR) with the Cole model

10. Eligibility

Sex
All
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
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
Our Lady's Hospital for Sick Children Crumlin
City
Dublin
ZIP/Postal Code
12
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
353-1-409-6659
Facility Name
Birmingham Children's Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin W. English, MD
Phone
44-121-333-8412
Email
martin.english@bch.nhs.uk
Facility Name
Bristol Royal Hospital for Children
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-117-342-0205
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amos Burke, MD
Phone
44-1223-348-151
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Glaser, MD
Phone
44-113-206-4984
Email
adam.glaser@leedsth.nhs.uk
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johann Visser, MD
Phone
44-116-258-5309
Email
johannes.visser@uhl-tr.nhs.uk
Facility Name
Royal Liverpool Children's Hospital, Alder Hey
City
Liverpool
State/Province
England
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather P. McDowell, MD
Phone
44-151-293-3679
Facility Name
University College Hospital
City
London
State/Province
England
ZIP/Postal Code
NW1 2PCE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Michelagnoli, MD
Phone
44-20-7380-9064
Email
maria.michelagnoli@uclh.nhs.uk
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
Gill Levitt, MD
Phone
44-20-7405-9200 ext. 0073
Facility Name
Royal Manchester Children's Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M27 4HA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernadette Brennan, MD
Phone
44-161-922-2227
Email
bernadette.brennan@cmmc.nhs.uk
Facility Name
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliet Hale, MD
Phone
44-191-282-4101
Email
j.p.hale@ncl.ac.uk
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Hewitt, MD, BSc, FRCP, FRCPCH
Phone
44-115-924-9924 ext. 63394
Email
martin.hewitt@nuh.nhs.uk
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate Wheeler, MD
Phone
44-186-522-1066
Facility Name
Children's Hospital - Sheffield
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary P. Gerrard, MBChB, FRCP, FRCPCH
Phone
44-114-271-7366
Email
mary.gerrard@sch.nhs.uk
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janice A. Kohler, MD, FRCP
Phone
44-23-8079-6942
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
Mary Taj, MD
Phone
44-20-8642-6011 ext. 3089
Facility Name
Royal Belfast Hospital for Sick Children
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT12 6BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony McCarthy, MD
Phone
44-289-063-3631
Email
anthonymcarthy@royalhospital.n.i.nhs.uk
Facility Name
Royal Aberdeen Children's Hospital
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronica Neefjes
Phone
44-1224-550-217
Facility Name
Royal Hospital for Sick Children
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH9 1LF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
W. Hamish Wallace, MD
Phone
44-131-536-0426
Facility Name
Royal Hospital for Sick Children
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milind D. Ronghe, MD
Phone
44-141-201-9309
Facility Name
Childrens Hospital for Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Traunecker, MD, PhD
Phone
44-29-2074-2285
Email
heidi.traunecker@cardiffandvale.wales.nhs.uk

12. IPD Sharing Statement

Learn more about this trial

CYP3A5 Gene as a Risk Factor for Kidney Damage in Young Patients With Cancer Treated With Ifosfamide

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