CCL0922: Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor

A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor (SCUSF 0901; ACCL0922)

Categories:

Brain Tumor

Phase I/II

Diseases Treated:

Brain Tumor : Previously treated brain tumors

Eligibility Overview:

  • Age is > 6 years and < 17 years & 10 months at the time of study entry.
  • Off treatment and progression–free for at least 12 months and less than and equal to 14 years.
  • Diagnosis of a primary brain tumor treated with at least one of the following :
    • Neurosurgical resection of the brain tumor;
    • Cranial irradiation;
    • Any chemotherapy to treat the brain tumor

Description

This is a randomized phase II study for children previously treated for a primary brain tumor with surgery, chemotherapy, and/or radiation therapy but is now off treatment.

Some children who are treated for a brain tumor have difficulty with attention, memory or the speed at which information is processed by the brain. This can be due to the brain tumor or the treatment for the brain tumor. This study will test whether the drug Modafinil can improve changes in attention, memory, or other thought processes (also referred to as neurocognitive changes) in children who were previously treated for brain cancer.

Participants and their parents/caregivers will complete a series of tests and questionnaires to evaluate the child for neurocognitive deficits in attention, working memory or processing speed. If results show that the participant has a neurocognitive deficit, they can be randomly assigned to receive either Modafinal (a stimulant drug) or placebo (identical looking pill which contains no medicine) twice a day for 6 weeks. Participants will be evaluated weekly by phone or in the clinic for side effects, and will complete a daily medicine log. After 6 weeks, participants and parents will repeat the tests to determine if there was improvement in neurocognitive function.

Objectives

  • To learn if a 6-week drug trial of modafinil, compared to placebo, is associated with improvement in neurocognitive function as defined by parent report and test results.
  • To evaluate the safety of modafinil in children under the age of 16.
  • To determine whether modafinil, compared to placebo, is associated with improved executive function (apart from working memory), as assessed using modules from a standardized test
  • To determine whether modafinil, compared to placebo, is associated with reduced fatigue.

Eligibility criteria for registration, among others, include:

  • Age is > 6 years and < 17 years & 10 months at the time of study entry.
  • Off treatment and progression –free for at least 12 months and less than and equal to 14 years. Treatment cessation is defined as the final dose (fraction of radiation), or date of surgery, whichever occurred last.
  • Diagnosis of a primary brain tumor treated with at least one of the following :
    • Neurosurgical resection of the brain tumor;
    • Cranial irradiation
    • Any chemotherapy to treat the brain tumor
  • Parent/legal guardian and child are able to read English or Spanish. 

For the current eligibility status of this clinical study, patient’s family, relatives and/or referring physicians may contact St. Jude Children’s Research Hospital at (901) 595-4599 or (901) 595-2544.

Contact

Amar Gajjar, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Phone: 901-595-2544 or 901-595-4599
Fax: 901-595-6211

OR

Tabatha E. Doyle, RN
Coordinator, Brain Tumor Program
MS 260
262 Danny Thomas Place
Memphis, TN 38105
Phone: (901) 595-2544
FAX: (901) 595-6211

Referring or consulting clinicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.