Why are we doing this study?
The purpose of this research study is to learn about the safety of adding a drug called Metformin, to chemotherapy in patients with tumors that are longer responding to other types of therapy. The chemotherapy in this study is a combination of Vincristine, Irinotecan and Temozolomide (VIT). We are trying to find the highest dose of Metformin that can be given safely to children receiving VIT chemotherapy. We will do this by testing different doses of Metformin in different groups of children. We will also study how the body processes Metformin.
Metformin is a medication approved by the FDA for treatment of type II diabetes in people age 10 and older. In patients with diabetes, Metformin use has been associated with decreased incidence of cancer and improved overall survival. In this study, metformin is considered experimental because it is not yet approved for use in the treatment of cancer.
Who can participate in this study?
We are looking for patients between 1 and 18 years of age who have been diagnosed with a recurrent or refractory solid tumor or primary brain tumor. There are some other requirements you must meet to protect your safety. If you are interested in taking part in this study, the study team will discuss this with you.
What will happen during this study?
If you and your child agree to be part of this research, you will have some tests done to make sure that is okay for your child to be in this study. Your child will be in the study for about 12 months and will be seen in the clinic about twice a week while he/she is receiving the treatments.
Your child will receive the treatment in cycles. Each cycle is 21 days long. For the first cycle, your child will only receive VIT therapy. If your child tolerates the first cycle of chemotherapy, Metformin will be added after he/she completes the first cycle. Metformin will be given to your child by mouth twice a day. It is available as both a liquid and a tablet. During the study, your child will have exams and tests done to monitor his/her health at regularly scheduled time points.
Is this risky or painful?
You/your child may experience side effects form taking the medicines involved in this study. All people who receive cancer treatment are at risk of having side effects. Common side effects of chemotherapy include nausea, vomiting, and hair loss. Chemotherapy may also decrease the number of blood cells which may result in fatigue, increased chance of infection, and increased chance of bleeding. Some infections may be serious and require hospitalization.
The most common side effects of metformin include: diarrhea, nausea, vomiting, and flatulence. There may be other, less common side effects and the study team will discuss these with you. Metformin can cause problems for patients whose kidneys do not function properly. All study patients will be monitored closely for side effects and potential health problems.
The procedures and tests done during this study also carry some additional risks. The study team will explain these to you prior beginning the study and before each procedure is done.
Does this cost anything?
You or your insurance company will be responsible for the costs of any tests and procedures done as part of the routine medical care for your condition that would be done regardless of whether you chose to participate or for your child to participate in this study. The study medication, metformin, will be provided at no cost. Any tests/procedures done specifically for the research study will be paid for by the study sponsor.
What are the benefits?
We do not know if your child will directly benefit from being in this study. We hope the information we gain from this study will help other patients in the future.
Where can I get more information?
More information about this study can be found on ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT01528046