Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors

• Status: Suspended
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Claudius Regaud
• Treatments: Cisplatin; Ifosfamide; Isophosphamide mustard

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