Introduction

This family protocol summary provides a general overview of the Children's Oncology Group (COG) study AOST1322. It tells who is eligible and gives basic information about the study. More details about the study are in the consent form and protocol. You can get these from your oncologist.

AOST1322 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 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 I 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: AOST1322

Official Title: A Phase II Study of Eribulin in Recurrent or Refractory Osteosarcoma

Study Opening Date: AOST1322 opened on August 20, 2014. The AOST1322 committee hopes to enroll 19 patients during the first phase. Each of these patients will be evaluated for disease response (complete response or partial response versus no response). AOST1322 reached stage 1 accrual goals and was closed to further patient entry as of 12/15/14.

General Patient Eligibility

• Age: 12 - 50
• Diagnosis:Recurrent or resistantosteosarcoma with disease that is measurable by scans or physical exam

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

General Background and Study Goal

New ways to treat patients who have osteosarcoma that has not responded to primary treatment or has returned are needed. Doctors would like to find more drugs that can be used for patients who have progressed or recurred with standard treatment.

Eribulin is a drug that blocks cells from growing at a specific phase of the cell growth cycle, causing cell death. In laboratory tests, eribulin has been shown to be a promising drug to treat many pediatric solid tumors, including osteosarcoma.

Eribulin has been safely used in phase II and III studies to treat metastatic breast cancer in adults. This study will look at how osteosarcoma patients respond to eribulin as a single drug treatment. All teens and adults who are part of this study will be treated with eribulin. All patients will receive the same dose of eribulin.

Summary of the Treatment

Eribulin is given on day 1 and day 8 IV followed by a 14 day rest period. This constitutes a 21 day cycle.

The study continues for up to 24 months or 34 cycles whichever occurs first.

Special Considerations

Study doctors would also like to take optional blood samples to learn more about how your body handles the drug eribulin and the effects eribulin has on your body and metabolism. Some blood is requested when you would not usually need to have a blood sample taken.

You do not have to do these tests if you do not want to. You can still be in the study if you do not want to do these tests.

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

Michael Isakoff, MD

Connecticut Children's Medical Center

Hartford, CT

FAMILY PROTOCOL SUMMARY REVIEW/APPROVALS