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Introduction

This family protocol summary provides a general overview of the Children's Oncology Group (COG) study AOST1321. It tells who is eligible and gives basic information about the study. More details about the study are in the consent form. You can get this from your oncologist.

AOST1321 is a Phase II clinical trial. A trial is another word for a study. This study (clinical trial) is a therapeutic clinical trial. That means it is done to learn about a treatment - its safety and how well it works. The purpose of a Phase II trial is to learn if a new treatment works in treating a specific type of cancer and how it affects the body.

In a Phase II trial, patients with a specific type of cancer receive a new treatment using a dose that was found to be safe in a Phase 1 trial. Patients are checked for side effects of the treatment and to see whether the cancer shrinks or goes away.

Phase II trials are offered to patients whose disease has not responded to standard types of treatments or to patients whose disease doesn't have a standard treatment.

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 in clinical trials at www.childrensoncologygroup.org. Always discuss any questions that you may have with your health care team.

Study Number

AOST1321

Official Title

Phase 2 Study of Denosumab, a RANK Ligand Antibody, for Recurrent or Refractory Osteosarcoma

Study Opening Date

AOST1321 opened on November 9, 2015. The AOST1321 committee has no defined end date to this study and no specific number of patients to enroll.

General Patient Eligibility

Please consult your doctor to determine whether you or your child may participate in this study.

General Background and Study Goal

Patients who have osteosarcoma that no longer responds to treatment or comes back after treatment is complete have a poor outcome with current treatments. Denosumab is a new agent that has shown activity in a variety of cancers including osteosarcoma in laboratory studies. Denosumab is a monoclonal antibody. It is an antibody that is made to attach to specific problem areas within a cancer cell.

The goal of this study is to determine whether denosumab will have an effect in controlling the disease rate or produce a response in patients with osteosarcoma.

Summary of the Treatment

Stratum 1 closed to accrual on 4/12/2016 as patient accrual goals were reached.

Temporary closure to accrual on 7/12/2017 pending evaluation of the patients currently on the study.

Special Considerations

Risks and Side Effects

Chemotherapy can cause side effects during and after treatment. All patients will be closely monitored for possible side effects of the medicines. All risks and side effects will be explained by your treatment team during the consent process. They can answer any questions that you may have about giving permission for your child to be in the clinical trial or other aspects of care. Please refer to the consent form for a detailed explanation of the side effects associated with the treatment on this study.

Contact Information

Your child's oncologist and nurses are the best sources for further information.

Study Chair

Katherine Janeway MD
Dana Farber Cancer Institute

FAMILY PROTOCOL SUMMARY REVIEW/APPROVALS

Initial development Name Date
Written by Jill Lee CPNP-AC December 9, 2015
Reviewed/approved by (PI) Katherine A. Janeway, MD, MMSc April 4, 2016
Ongoing review
Reviewed and updated by Stacy Whiteside APRN, MS, CPNP-AC, CPON February 10, 2017
Jill Lee APRN, MSN, CPNP-AC, CPON January 26, 2018

© The Children's Oncology Group
The information and content provided on this website is made available for informational purposes only for children and their families affected by cancer. While the Children's Oncology Group strives to provide accurate and up-to-date information, the information may be out of date or incomplete in certain respects. Please do not rely on this information and seek the care of a qualified medical professional if you have questions regarding a specific medical condition, disease, diagnosis or symptom. The information and content presented herein is not intended to replace the independent clinical judgement, medical advice, screening, health counseling, or other intervention performed by your (or your child's) health care provider. Please contact "911" or your emergency services if this is a health emergency. No endorsement of any specific tests, products, or procedures is made herein.