Introduction:

This Family Protocol Summary is intended to provide a general overview of the Children's Oncology Group Study #ACCL0431. It will provide information about who is eligible for this study and basic information regarding the specifics of the study. The informed consent and protocol contain the full details of the study. Those documents are available to you from your oncologist.

This study includes an optional biology study. If you consent to being a part of this study, you can choose to participate in the biology study or not. For patients who consent to this optional biology study, saliva or inner cheek smears/swab will be obtained and sent to a laboratory. These specimens will be examined for the presence of certain genes that may place patients at risk for developing hearing loss with exposure to cisplatin chemotherapy. This type of research is done to improve/expand what is known about the side effects of chemotherapy.

It is important to understand that participating in a clinical trial is entirely voluntary. The decision about whether or not to participate will not affect the care provided by the health care team in any way. You can find additional information about participation on clinical trials on www.childrensoncologygroup.org. Always discuss any questions that you may have with your healthcare team.

Brief Title: Sodium Thiosulfate for the Prevention of Cisplatin-Induced Hearing Loss in Children

Official Title: A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children

Trial Opening Date: Opened 6/23/08 with an accrual goal of 120 patients over a 3 year period.

General Patient Eligibility:

Patients must 1 year of age or older, but younger than 19 years old.

Patients must have newly diagnosed cancer that will be treated with the chemotherapy medicine cisplatin. The most common childhood cancers that are treated with cisplatin include germ cell tumors, hepatoblastoma, medulloblastoma, neuroblastoma and osteosarcoma. However, patients with any other cancer are also eligible as long as cisplatin will be used for treatment.

In order to participate in this study, the chemotherapy medicine cisplatin needs to be given at a total dose of 200 mg/m2 or more, with each cisplatin dose given over 6 hours or less.

Other enrollment criteria

Patients who participate in this study must also be enrolled on the hearing assessment study, ACCL05C1.

Patients enrolled on any COG therapeutic study for treatment of their cancer may NOT participate in this study.

General Background and Study Goal:

Cisplatin is a chemotherapy medicine that is used for many types of childhood cancer. Cisplatin can cause side effects to the blood and kidney systems. Cisplatin may also cause a side effect called ototoxicity. Ototoxicity is damage to the hearing system that causes hearing loss or ringing in the ears (tinnitus). This hearing loss can be permanent. Sodium thiosulfate (STS) is a medicine that may prevent this kind of hearing loss. The goal of this research study is to evaluate if STS can prevent hearing loss in participants receiving cisplatin chemotherapy for newly diagnosed cancers.

Summary of the Treatment

All participants of this research study will receive chemotherapy medicine called cisplatin as part of their cancer treatment plan. There are two treatment arms to this study. The two treatment arms are the same except that 1 arm includes the drug Sodium thiosulfate (STS) while the other arm does not. The treatment arm that does not receive STS is called the observation arm. Participants will be randomly placed on one of the 2 treatment arms. Hearing tests will be obtained and reviewed on all children/adolescents on the study to determine if STS is effective in preventing hearing loss. The side effects on the blood and kidney systems will also be compared between the two groups. Whether or not the patient receives STS, the cancer treatment plan will be unchanged. The cancer treatment plan will be that which is recommended by the patient’s pediatric oncology doctor.

  • STS Arm: Participants in the study will get the drug sodium thiosulfate (STS).
  • Observation Arm: Participants in the study will not get STS.

Tests and Procedures

    • Sodium (Salt) Levels: All participants of this research study will have sodium (salt) levels in the blood checked each day before cisplatin chemotherapy is given. For patients assigned to receive STS, if the sodium level is above the normal range, the STS dose will be not be given on that day. The STS dose will be given the next day if the sodium level has returned to normal.

 

    • Hearing Tests: Hearing tests will be obtained within 8 days before each course of cisplatin, and then 4 weeks and 1 year after the final course of cisplatin chemotherapy. If the cancer treatment includes a hematopoietic stem cell transplant, the hearing tests will be repeated before the transplant procedure, and then 4 weeks and 1 year after the transplant procedure. The schedule of hearing tests used in this study is the same as most hospitals use for monitoring children/adolescents being treated with cisplatin chemotherapy.

 

  • Other Routine Tests: These tests are done to monitor both the good and bad effects of the cancer treatment. These tests may include the physical exam, medical history, blood and urine samples, and x-rays. These tests are routinely done as part of the standard cancer care of patients.

Risks and Side Effects

Chemotherapy can cause short-and long-term side effects. All patients will be closely monitored to reduce the likelihood of negative side effects. All risks and side effects will be explained in detail by your healthcare team during the consent process. They can answer any questions that you may have regarding participation on the clinical trial or other aspects of care. Please refer to the consent document for a detailed explanation of the side effects associated with the treatment on this study.

Contact Information

Your child’s oncologist is the best source for further information. Physicians with eligible patients should refer questions to the principal investigator of this study:

Principal Investigator
David R. Freyer, DO, MS
Hematology/Oncology
Childrens Hospital Los Angeles
Childrens Center for Cancer and Blood Diseases
4650 Sunset Blvd, Mailstop 54
Los Angeles, CA 90027-6016
Phone: 323-361-8953
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

National Clinical Trials Network Logo NCI-COG Pediatric MATCH Logo

 

Project Every Child Logo

 

Step Up More Funding for Childhood Cancer LogoCOG Foundation Logo   amazon smile donate