Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors

Institut Claudius Regaud80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

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

Interventions

cisplatinDRUG

ifosfamideDRUG

laboratory biomarker analysisOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut Claudius Regaud

Toulouse, France

Outcomes

Primary Outcomes

Evolution of different biomarkers

Sensitivity, specificity, and predictive value (positive and negative) of different markers

Data from ClinicalTrials.gov

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