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

• 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 ]
  

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

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.