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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00514345
First received: August 8, 2007
Last updated: August 9, 2013
Last verified: June 2009
  Purpose

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.


Condition Intervention
Chemotherapeutic Agent Toxicity
Sarcoma
Unspecified Childhood Solid Tumor, Protocol Specific
Genetic: gene expression analysis
Genetic: polymorphism analysis
Procedure: management of therapy complications

Study Type: Observational
Official Title: CYP3A5 Genotype as a Potential Risk Factor for the Development of Ifosamide Nephrotoxicity in Children

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • CYP3A5 genotype [ Designated as safety issue: No ]
  • Renal function and nephrotoxicity [ Designated as safety issue: Yes ]
  • Relationship between CYP3A5 genotype and ifosfamide nephrotoxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comparison of measured glomerular filtration rate (GFR) with the Cole model [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514345

Locations
Ireland
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland, 12
United Kingdom
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
Bristol Royal Hospital for Children
Bristol, England, United Kingdom, BS2 8BJ
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom, L12 2AP
University College Hospital
London, England, United Kingdom, NW1 2PCE
Great Ormond Street Hospital for Children
London, England, United Kingdom, WC1N 3JH
Royal Manchester Children's Hospital
Manchester, England, United Kingdom, M27 4HA
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom, EH9 1LF
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom, G3 8SJ
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
Principal Investigator: Gareth Veal University of Newcastle Upon-Tyne
  More Information

ClinicalTrials.gov Identifier: NCT00514345     History of Changes
Other Study ID Numbers: CCLG-PK-2007-02  CDR0000560128  EU-20743 
Study First Received: August 8, 2007
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on December 02, 2016