CYP3A5 Genotype as a Potential Risk Factor for the Development of Ifosamide Nephrotoxicity in Children
N/A
20 Years
Both
Chemotherapeutic Agent Toxicity, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific
Trial Information
CYP3A5 Genotype as a Potential Risk Factor for the Development of Ifosamide Nephrotoxicity in Children
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.
Inclusion 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
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
CYP3A5 genotype
Safety Issue:
No
Principal Investigator
Gareth Veal
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Newcastle Upon-Tyne
Authority:
Unspecified
Study ID:
CDR0000560128
NCT ID:
NCT00514345
Start Date:
July 2007
Completion Date:
Related Keywords:
- Chemotherapeutic Agent Toxicity
- Sarcoma
- Unspecified Childhood Solid Tumor, Protocol Specific
- 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
- Neuroectodermal Tumors, Primitive
- Neuroectodermal Tumors, Primitive, Peripheral
- Sarcoma
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