Introduction

This summary is intended to provide a general overview of the Children's Oncology Group study ACCL0922. It tells you who can be in this study and other basic information. The informed consent has more details of the study. You can get those from your oncologist.

ACCL0922 is a Cancer Control and Supportive Care (CCLSC) Study. CCLSC studies are performed to help learn how to best deal with, or prevent complications of cancer and cancer treatment. CCLSC studies often focus on complications that affect how people feel or what they can do during or after treatment (physical and emotional quality of life).

If you consent to being a part of this study, your child will receive one of two different treatment arms. The treatment arm 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. The randomization process is described in the COG Family Handbook for Children with Cancer.

Participating in a clinical trial is voluntary. The decision about whether or not to participate will not affect the care provided by the health care team in any way. You can find more information about clinical trials at www.childrensoncologygroup.org. You can discuss any questions with your treatment team.

Study Number

ACCL0922

Study Title

A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor

Study Opening Date

ACCL0922 opened on 7/25/12

Study Closing Date

ACCL0922 reached accrual goals and was closed to further patient entry as of 5/20/16

General Patient Eligibility

• Age: 6 - 17
• Diagnosis of brain tumor treated with surgery, radiation or chemotherapy
• No cancer therapy for 1 year but not longer than 7 years earlier

Please consult your doctor to determine whether your child may participate in this study.

General Background and Treatment

Neurocognitive dysfunction (difficulty thinking and learning) affects nearly half of all childhood cancer survivors, especially children treated for a brain tumor. Methylphenidate (Ritalin), a stimulant medicine used to treat Attention Deficit Disorder (ADD), has shown good results in improving attention for cancer survivors.

Modafinil is another stimulant medicine that has been studied in children with ADD and excessive sleepiness, as an alternative to methylphenidate. It has also shown good results for improving cognition, mood, and fatigue in adult breast cancer and brain tumor survivors. ACCL0922 will compare Modafinil to a placebo (sugar pill) to see if there is improvement in attention, memory, fatigue or processing speed. We will also measure other potential side effects of the medication.

Summary of the Treatment

Participants will be randomized to receive daily Modafinil pills or placebo pills for 6 weeks. Neither the participants nor their medical team will know if they are receiving placebo or Modafinil. The study will compare side effects, cognitive function, and fatigue.

Special Considerations

Prior to entering this study, potential participants must complete a computerized cognitive screening test. The testing will take about 30 minutes, including a practice test. If test results show that a neurocognitive deficit is present, the child will be eligible to enroll on the study.

Study participant requirements:

• daily medicine logs
• weekly telephone calls
• clinic visit at 2 weeks (1 hour)
• clinic visit at 6 weeks (1 hour)

Risks and Side Effects

All patients will be closely monitored for possible side effects of the medicine. All risks and side effects will be explained by your treatment team during the consent process. They can answer any questions that you may have about giving permission for your child to be in the clinical trial or other aspects of care. The study consent form has more details about possible side effects of the treatment in this study.

Contact Information

Your child's oncologist and nurses are the best sources for further information.

Principal Investigator

Nicole J. Ullrich, MD, PhD
Dana Farber/Harvard Cancer Center

FAMILY PROTOCOL SUMMARY REVIEW/APPROVALS