Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Investigation of Cisplatin-Related Kidney Toxicity

NCT00984035

Cancer

COMPLETED

Protecting the Kidney's Proximal Tubules From Platinum-Based Chemotherapy Toxicity

NCT07018622

Solid Tumors Cisplatin Nephrotoxicity

ACTIVE_NOT_RECRUITING PHASE2

Cisplatin, Gemcitabine Hydrochloride, and Sorafenib Tosylate in Treating Patients With Transitional Cell Cancer of the Bladder

NCT01222676

Bladder Cancer

UNKNOWN PHASE2

Cisplatin Induced Kidney Toxicity

NCT04442516

Acute Kidney Injury Cancer

RECRUITING

Oxaliplatin in Cancer Patients With Impaired Kidney Function

NCT00001835

Kidney Disease Neoplasm Neoplasm Metastasis

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cisplatin

Intervention Type DRUG

ifosfamide

Intervention Type DRUG

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No