Protocol

CCL0922: A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Tumor (SCUSF 0901; ACCL0922) Site CTEP ID= TN024

Diseases

Brain Tumor : Previously treated brain tumors

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


Eligibility criteria for registration, among others, include:

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) 595-5353

Or

Tabatha E. Doyle, RN
Coordinator, Brain Tumor Program
Phone: (901) 595-2544

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@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.