Chemotherapeutic Agent Toxicity, Renal Toxicity, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
renal toxicity, chemotherapeutic agent toxicity, unspecified adult solid tumor, protocol specific
Brief summary
RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This research study is evaluating kidney damage in patients receiving cisplatin and ifosfamide for solid tumors.
Detailed description
OBJECTIVES: Primary * Identify and evaluate the early biomarkers of renal toxicity in patients with solid tumors treated with cisplatin and ifosfamide. Secondary * Correlate the modification of biomarker studies and blood concentrations of cisplatin. OUTLINE: Patients receive standard chemotherapy comprising cisplatin and/or ifosfamide. Blood and urine samples are collected on days 1 and 2 (or day 3 if receiving ifosfamide only) during the first 3 courses. Samples are analyzed to determine plasma concentrations of residual cisplatin and to obtain urinary-protein profiles to measure renal toxicity.
Interventions
DRUGcisplatin
DRUGifosfamide
OTHERlaboratory biomarker analysis
Sponsors
Institut Claudius Regaud
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of a solid tumor * Any location allowed * Metastatic disease allowed * Planned treatment comprising cisplatin and/or ifosfamide as standard chemotherapy PATIENT CHARACTERISTICS: Inclusion criteria: * Life expectancy \> 3 months * Creatinine clearance ≥ 60 mL/min * Must be available for follow up * Not pregnant or nursing * Not under guardianship or in prison
Exclusion criteria
* Prior drug-related nephrotoxicity * Acute, uncontrolled urinary infection or \> 48-hours * Pre-existing hemorrhagic cystitis * Weak bladder * Bilateral obstruction of urinary tract * Insufficient, severe bone marrow hypoplasia * Cardiorespiratory condition contraindicating hyperhydration * Hearing impairment * Hypersensitivity to cisplatin or products containing platinum * Major psychiatric condition (severe depression, psychosis, dementia) PRIOR CONCURRENT THERAPY: * No prior yellow fever vaccine, live attenuated vaccine, or phenytoin * No concurrent participation in another biomedical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evolution of different biomarkers | — |
| Sensitivity, specificity, and predictive value (positive and negative) of different markers | — |
Countries
France
Outcome results
None listed