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A Phase 1 Window, Dose Escalating And Safety Trial Of Metformin In Combination With Induction Chemotherapy In Relapsed Refractory Acute Lymphoblastic Leukemia

Metformin With Induction Chemotherapy Of Vincristine, Dexamethasone, Doxorubicin And Peg-Asparaginase (Vpld)

 

Why are we doing this study?

The purpose of this research study is to learn about the safety and feasibility of adding the medication metformin to induction chemotherapy (the first part of treatment) for recurrent acute lymphoblastic leukemia (ALL). Researchers are also trying to determine the proper dose of metformin and to find out more about how the medicine is processed by the body.

 

Metformin is a medication approved by the FDA for treatment of Type II diabetes in people age 10 and older. In this study, metformin is considered experimental because it is not yet approved for use in the treatment of ALL. Previous research has shown that metformin is quite safe in children and is associated with decreased incidence of cancer and improved overall survival. It is hoped that this study may provide useful information for doctors whose patients already take metformin at the time of cancer diagnosis.

 

Who can participate in this study?

We are looking for patients diagnosed with ALL or lymphoblastic lymphoma that has relapsed. Participants may be male or females who were aged 1-30 at their initial diagnosis. 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/your child agree to be part of this research, you will have some tests done to make sure that is okay for you/your child to be in this study. If the study doctor decides it is okay, you/your child will receive 1 to 4 courses of induction chemotherapy using the drugs methotrexate, vincristine, dexamethasone, doxorubicin, cytarabine, and PEG-asparaginase. These chemotherapy drugs are all FDA-approved and are considered standard of care medicines for the treatment of cancer. The study drug, metformin, will be given to you/your child by mouth twice a day for 24 hours prior to starting chemotherapy. You/your child will be asked to come to clinic about twice a week during the study for exam and blood draws. Additionally, bone marrow aspiration, lumbar puncture, and echocardiogram procedures will be done at scheduled time points. The study team will give you more information about the tests and the schedule of testing before you decide to participate.

 

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 you/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/NCT01324180

For more details, please contact Dr. Bhuvana Setty at 614-722-3553, bhuvana.setty@nationwidechildrens.org or Amy Yekisa at 614-722-6570, amy.yekisa@nationwidechildrens.org

Nationwide Children's Hospital
700 Children's Drive Columbus, Ohio 43205 614.722.2000