Clinical Research Study Viewer

ACNS0821 Randomized Phase II Screening Trial for Recurrent/Refractory Medulloblastoma/CNS PNET of Childhood

Purpose of study:

This new study uses the results of these earlier studies, and looks at how well giving temozolomide and irinotecan daily for 5 days every 28 days works when given to children and young adults with recurrent or refractory medulloblastoma/PNET.

Although we think that this new treatment might be able to improve or slow the growth of recurrent or refractory medulloblastoma/PNET for some people, we would like to find out if adding another drug to the combination will help more people. In this study, we will add the experimental drug bevacizumab for half of the people that participate in this study.
Bevacizumab works differently than the chemotherapy drugs temozolomide and irinotecan. As tumors grow, they need new blood vessels to grow with them in order to receive nutrients and survive. This blood vessel growth is called angiogenesis. Bevacizumab is an angiogenesis inhibitor. That means bevacizumab works by blocking the growth of blood vessels, including blood vessels in tumors. Adding bevacizumab to treatment with temozolomide and irinotecan is experimental.

The overall goals of this study are to:

  • Find out what effects, good and/or bad, giving temozolomide together with irinotecan daily for 5 days every 28 days has on people with recurrent or refractory medulloblastoma/PNET.
  • Find out what effects, good and/or bad, adding bevacizumab to treatment with temozolomide and irinotecan has on people with recurrent or refractory medulloblastoma/PNET.
     


Who can participate:

Patients must be no greater than 21 years of age at the time of study enrollment.

Medulloblastoma or PNET of childhood that has relapsed or become refractory to standard chemotherapy.

Patients must have had histologic verification of the malignancy at original diagnosis or at the time of recurrence.

Additional screening for eligibility will be required.

What will happen during the study:

Randomization

Subjects (people participating in the study) will receive one of two different treatment plans. The treatment plan they receive is decided by a process called randomization. Randomization means that the treatment is assigned based on chance. It is a lot like flipping a coin, except that it is done by computer to make sure that there are about the same number of people on each treatment plan of the study. Some subjects will be randomized to receive treatment on Arm A; others will be randomized to receive treatment on Arm B.

 

Treatment Plan

Treatment will be given in cycles that last 4 weeks (or 28 days) each. You will get 2 cycles of treatment and then there will be an evaluation. Evaluation means that you will have imaging studies (scans) done to see if the tumor has changed. If the tumor has not gotten larger and you do not have bad side effects, you will continue with 2 more cycles of treatment. Then you will have another evaluation of your tumor. After the fourth cycle, your doctor may suggest you continue with treatment if your tumor is shrinking or staying the same size and you do not have bad side effects. If this happens, up to 8 more cycles of treatment may be given, for a total of 12 possible cycles.

The two different treatment plans are the same except for the drug bevacizumab.

The two treatment arms are called Arm A and Arm B as follows:

  • Arm A: (TEMO+IRIN) - Treatment with temozolomide and irinotecan
  • Arm B: (TEMO+IRIN+BEVA) - Treatment with temozolomide and irinotecan and bevacizumab

Who to contact:

PI: Mark Ranalli, MD

614-722-3563
Mark.Ranalli@nationwidechildrens.org
 

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