IRB Number:

07-007675

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

Patients are being asked to take part in this study because they are scheduled to receive treatment with a chemotherapy (cancer-killing) drug, called cisplatin. Cisplatin is a drug that may cause a side effect called ototoxicity. Ototoxicity is damage to the patient's hearing system that causes hearing loss.


Why Is This Study Being Done?
When people are being treated for cancer they receive chemotherapy drugs that can cause hearing loss. It is standard care to have hearing tests on a regular basis to monitor for hearing loss. The standard type of hearing tests is called conventional audiometry. In this study, researchers want to learn more about evaluating for ototoxicity by looking at conventional audiometry in different ways and by using two new types of hearing tests. These two new tests are called ultrahigh frequency (UHF) audiometry and otoacoustic emission and are more sensitive to measuring hearing loss than conventional tests.


The goals of this study are to:
- Determine the best way to recognize ototoxicity
- Determine if it is possible to use two hearing tests, ultrahigh frequency (UHF) audiometry and evoked otoacoustic emission (OAE), as extra tests to measure ototoxicity
- Have the researchers review the results of all the hearing tests done on patients on this study. This process is called central review. It allows researchers to evaluate the quality of the tests done at all the hospitals taking part in this study.

Who is Eligible to Participate in the Study?

-Patient is planning to undergo treatment with any cisplatin-containing therapeutic regimen for cancer
- No prior cisplatin received

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

If deciding to take part, patients will receive hearing tests (regular hearing tests, otoscopy (looking in the ear with a special instrument called an otoscope) and UHF and/or OAE, depending on which are available at their treating institution) at several time points:
1. Before beginning first course of cisplatin
2. Before beginning each subsequent course of cisplatin chemotherapy
3. Four (4) weeks after patient's last dose of cisplatin

Patients will also receive these hearing tests if they receive a hematopoietic progenitor cell transplant. The hearing tests will be given as follows:
1. Before the transplant procedure
2. Four (4) weeks after the transplant procedure
These hearing tests are not painful and take about 30-45 minutes to complete. The results of all the hearing tests will be shared with the patient and their doctor.

During an otoscopy, an audiologist or the doctor will look in the ear canal and at the ear drum with a special instrument called an otoscope. An otoscopy is very similar to what a doctor performs during a routine medical exam. This procedure may require that any earwax be removed. There is only slight discomfort associated with the otoscopy
and earwax removal.

It not known how often hearing tests should be done to monitor for hearing loss caused by chemotherapy, like cisplatin. The testing schedule used in this study is the same as what many institutions do on a regular basis to monitor hearing for all children who receive cisplatin, whether or not those patients are in a research study. Regardless of whether or not the patient decides to take part in this study, they will still have routine hearing tests done as part of their chemotherapy treatment.

Conventional (Regular) and Ultrahigh Frequency (UHF) Audiometry Hearing Tests
The conventional and UHF audiometry hearing tests are very similar. During these hearing tests, the patient will be seated within a sound-treated test booth. Headphones will be placed over their ears and/or earphones will be placed in their ears. The patient will listen for tones presented at different frequencies. The patient will be asked to give a response, such as raising a hand or pushing a button, whenever they hear a tone. The test will measure the softest level at which the patient is able to hear the tones. The patient will feel the headphones placed over their ears and/or the earphones placed inside their ears, but there is no discomfort during the test.

Evoked Otoacoustic Emission (OAE) Hearing Test
During the OAE hearing test, a small instrument with a soft rubber or foam tip will be placed in the patient's ear canal, first in one ear and then in the other. The patient will hear a series of tones or clicks; however, they will not need to respond to the tones/clicks. The machine will be able to measure how well the patient's hearing is. Patients will feel the soft tip in the ear, but there is no other feeling or discomfort associated with this test.

How long will the Study run?

The length of time the patient is on this study is determined by their cisplatin chemotherapy regimen. Most patients receiving cisplatin treatment are on therapy for at least three months and up to six months, not including the time that may be required for surgeries, recovery and overall response to cisplatin treatment. Therefore, the patient's length of time on this study will be equal to the amount of time they receive cisplatin therapy PLUS an additional four (4) weeks, in order to receive their last set of hearing tests.

Sponsor(s): Children's Oncology Group (COG)

Study Activation/Registration Date: 02/19/2008

IRB Review and Approval Date: 01/31/2008

Study Type: Symptom Management

Projected Accrual: The plan is to enroll up to 150 patients to participate from multiple medical centers.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Carola A.S. Arndt, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 07/03/2008