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Results summary of St. Jude clinical trial: 



RADBEV- A Phase I Trial of RAD001 (Everolimus) and Avastin (Bevacizumab) in Children with Recurrent Solid Tumors

Why was this study done?

The survival of children with solid tumors has improved, but the prognosis is poor for those whose disease has returned. In this study we wanted to know if a new tumor-fighting treatment combining two new chemotherapy drugs would be safe.

We sought to learn about the side effects that may occur when two drugs, everolimus and bevacizumab, are given to children and young adults with recurring tumors. We also wanted to find the highest doses of these drugs that can be given together without causing severe side effects.

Scientists in the lab have shown that everolimus can prevent cells from multiplying. The drug has also been used to help prevent organ rejection in organ transplants. Bevacizumab is a monoclonal antibody medication that can be targeted against cancer cells.

Both drugs are helpful in cancer treatment because of their ability to prevent angiogenesis, which is the formation of new blood vessels. Angiogenesis is normally a vital body function, but it also spurs tumor growth and helps cancer cells spread to other parts of the body.

In earlier, separate studies, cancer patients were able to tolerate the side effects of everolimus and bevacizumab. In one study of adult tumor patients, the drug combo improved the time that patients remained tumor-free..

When was this study done?

This study opened in July 2008 and closed in September 2015.

What did the study consist of?

Fifteen patients received 28 treatment courses of bevacizumab and everolimus. Children received bevacizumab through the vein every two weeks and everolimus by mouth every day.

What did we learn from this study?

The treatment was found to be tolerable and led to disease stabilization in selected heavily pretreated patients. The maximum tolerable doses of the combined drugs was similar to that used in adults. Even though both drugs are designed to stop the growth of new blood vessels, none of the patients had significant toxicity or damage to their blood vessels. Although this safety study was not meant to test whether the treatment was effective, the drug combo did control tumor growth in 4 of 15 patients.

What are the next research steps as a result of this study?

This study did not assess genetic abnormalities related to the cell growth processes that everolimus and other similar drugs are designed to stop. Future studies should study these molecular features, which may help identify patients that are more likely to benefit from similar therapies.

How does this study affect my child?

Every childhood cancer survivor should receive long-term follow-up care. Through the St. Jude After Completion of Care clinic, your child will receive information and guidance for care after treatment. Please speak with your St. Jude doctor about specific guidelines that apply to your child.

For more information

Please talk with your child’s St. Jude doctor about questions or concerns you have as a result of this study.

Publications generated from this study:

A Phase 1 Trial of Everolimus and Bevacizumab in Children with Recurrent Solid Tumors. Santana VM, Sahr N, Tatevossian RG, Jia S, Campagne O, Sykes A, Stewart CF, Furman WL, McGregor LM. Cancer. 2020 Apr 15;126(8):1749-1757.