Introduction

This lay summary is intended to provide a general overview of the Children’s Oncology Group (COG) study ALTE16C1. It will provide information about the adolescents and young adults who are 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.

It is important to understand that participating in a long-term follow-up study is entirely voluntary. The decision about whether or not to participate will not affect the care provided by the healthcare team in any way. You can find additional information about participation in non-therapeutic studies at www.childrensoncologygroup.org. Always discuss any questions that you may have with your health care team.

Study Number

ALTE16C1

Brief Title

COG ALTE16C1 – Effects of chemotherapy on fertility in male survivors of osteosarcoma.

Official Title

Effects of Modern Chemotherapy Regimens on Spermatogenesis and Steroidogenesis in Adolescent and Young Adult (AYA) Survivors of Osteosarcoma

Trial Opening Date

Opened October 10, 2017

General Patient Eligibility

• Male patients who are at least 18 years old and less than 51 years of age at time of enrolment
• Patients previously enrolled and randomized on AOST0331 or CCG7921 (CCG7921 has also been known as INT0133 and POG9351) OR received upfront therapies which included cisplatin with or without ifosfamide
• Osteosarcoma survivors without relapse (cancer coming back) or another cancer following treatment on AOST0331 or CCG7921
• Able to speak, read and write in English, French or Spanish

General Background and Study Goal

Cisplatin and ifosfamide form the backbone of therapy for some of the most common childhood, adolescent, and young adult (AYA) cancers such as germ cell tumors (cisplatin), osteosarcoma (cisplatin), Ewing sarcoma (ifosfamide), and CNS malignancies (cisplatin). However, the effect of these chemotherapies on male reproductive health is unknown. A better understanding of the testicular effects of cisplatin and ifosfamide will allow for identification of high risk patients and development of strategies to prevent testicular toxicity (loss of sterility). This study will evaluate the effects of cisplatin with or without ifosfamide on male fertility (specifically spermatogenesis and steroidogenesis) among childhood and AYA survivors treated with modern chemotherapies for osteosarcoma.

The overall goal of this study is to determine whether infertility and/or biomarkers of spermatogenesis (when the body makes sperm) and steroidogenesis (the way the body makes hormones) differ in male osteosarcoma survivors treated with cisplatin (with or without ifosfamide), compared to male controls without a history of cancer. In addition, the study will evaluate whether cisplatin with or without ifosfamide for the treatment of osteosarcoma alters sperm at the cellular level, specifically DNA methylation (how DNA functions and regulates).

Summary of the Treatment

Eligible patients will be contacted by their treatment COG site, and invited to participate via mail.

After receiving the initial enrollment and consent documentation from the COG site, a kit will be sent to each participant containing:

• Cover letter
• Directions Sheet for completion of study materials
• Men’s Health Questionnaire
• Saliva Collection kit
• Semen Collection kit
• Information about how to have a blood sample taken
• Pre-paid pre-addressed reply envelopes for return of completed study kits and materials

Risks and Side Effects

Your health care team can answer any questions that you may have about giving permission to be in the study. The study consent form has more details about any potential risks of participating in this study.

Contact Information

Your oncologist or treatment facility is the best source for further information. Physicians with eligible patients should refer questions to the ALTE16C1 principal investigator or to the Data Coordinating Center CRA:

Margarett Shnorhavorian, MD MPH FAAP FACS
ALTE16C1 Principle Investigator
Seattle Children’s Hospital

Amanda Adler, BA
ALTE16C1 Data Coordinating Center CRA
Seattle Children’s Hospital

FAMILY PROTOCOL SUMMARY REVIEW/APPROVALS