This study is comparing the effectiveness of palbociclib (IBRANCE®) when taken in combination with chemotherapy medicines irinotecan (IRN) and temozolomide (TMZ) versus IRN and TMZ alone for the treatment of Ewing sarcoma.

Who may participate

Joining a clinical trial is an important and personal decision. Your doctor may have mentioned this study to you, or perhaps you found your way here by yourself. Either way, thank you for your interest. 

This study may be an option if you or your child:

  • are between the ages of 2 – 20 years old 
  • have been diagnosed with recurrent/relapsed Ewing sarcoma

There are other requirements for taking part in this study. The study doctor will explain these to you. 
 

Conditions

Recurrent/relapsed Ewing sarcoma

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Sex

Male or Female

The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

Age

2 - 20 years

The age a person must be to participate in a clinical trial.

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

What to expect

If you decide to participate in this study, you or your child will be randomly assigned to receive the study medicine palbociclib in combination with IRN and TMZ, or IRN and TMZ alone. You or your child are twice as likely to receive palbociclib than not, and you will know what treatment you or your child have been assigned to receive. 

The study medicines are taken in 21-day treatment cycles. The number of treatment cycles completed will vary for everyone. You or your child may continue receiving treatment for as long as it is of benefit to you.  

You will need to attend regular visits so the study team can monitor how you or your child are responding to treatment. These visits will include health assessments, questionnaires, blood samples, ECGs, CT/MRI scans, and DEXA scans (X-rays that measure bone density).  

Length of study treatment

21-day treatment cycles

Length of study treatment is the length of time the study participants will receive the study treatment.

Number of study visits

Varies

Each clinical trial’s design specifies the number of study visits and the total length of the trial.

Long-term follow up

Phone calls or office visits to check in every 2 months for at least 2 years

Some studies require the study team to stay in contact with the participant for a period of time after the participant completes the main part of the study. This long-term follow up is to collect additional information on the study drug over time.

About Ewing sarcoma

Recurrent or relapsed Ewing sarcoma is a rare type of bone and soft tissue cancer that either does not improve from treatment or improves only for a limited time. Ewing sarcoma can occur at any age, but it is most common in children and teenagers. Unfortunately, current treatment options for recurrent/relapsed Ewing sarcoma are limited and may not work for everyone. Doctors are working to find better treatment options for people with Ewing sarcoma.  

Frequently asked questions

How long will my child or I be in the study?

Time in the study will vary for everyone and depends on how your cancer (or your child’s cancer) is responding to the treatment. Participants may continue to receive treatment in the study for as long as it is benefiting them. After completing treatment, you or your child will need to check in with the study team about every 2 months for at least 2 years.

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What if this study is not right for me or my child?

You or your child can choose to leave the study at any time, for any reason. Choosing to leave the study will not affect your Ewing sarcoma treatment or future medical care. We encourage you to speak with your oncologist about all available treatment options.

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How should my child or I take the study medicine?

The study medicines are taken in 21-day cycles. The study medicine palbociclib (IBRANCE®) is taken at home by mouth once a day for the first 14 days of each treatment cycle. The chemotherapies IRN and TMZ will be given by staff at the study site for the first 5 days of every treatment cycle.

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What are the possible side effects?

All medicines have the potential to cause unwanted side effects. The study doctor will discuss the possible risks and benefits of participating in this study with you before you or your child choose to enroll. You can choose to leave the study at any time.

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