Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Biologic Evaluation of Renal Toxicity of Cisplatin and Ifosfamide (TOXIPLAT)

Conditions
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Chemotherapeutic Agent Toxicity, Renal Toxicity, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: cisplatin
* Drug: ifosfamide
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: ifosfamide|nan|
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of different biomarkers |  |  | 
| Sensitivity, specificity, and predictive value (positive and negative) of different markers |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal toxicity, chemotherapeutic agent toxicity, unspecified adult solid tumor, protocol specific