Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT00695032
Status:
SUSPENDED
Last Update Posted:
2014-11-05
First Post:
2008-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors
Sponsor:
Institut Claudius Regaud
Organization:
Study Overview
Official Title:
Biologic Evaluation of Renal Toxicity of Cisplatin and Ifosfamide (TOXIPLAT)
Status:
SUSPENDED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: