Adderall-XR Versus Concerta For Cancer Treatment-Related Neurocognitive Sequelae And Depression In Pediatric Patients: A Randomized Phase II Study
- Compare the response rates in pediatric cancer patients with treatment-related
neurocognitive sequelae treated with dextroamphetamine-amphetamine (Adderall-XR®) vs
- Compare the durability of response at 12 weeks in patients who show a response at 3
weeks after treatment with these drugs.
- Determine whether patients who have no response to one of these study drugs can respond
to the other study drug.
- Determine the prevalence of depression and possible response to neurostimulant therapy
in this patient population.
OUTLINE: This is a randomized, multicenter study.
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral dextroamphetamine-amphetamine once daily for 3 weeks.
Patients who achieve response (based on neurocognitive testing) continue treatment for
a total of 12 weeks. Patients with no response after 3 weeks cross over to arm II after
a 48-hour washout period.
- Arm II: Patients receive oral methylphenidate once daily for 3 weeks. Responding
patients continue treatment for a total of 12 weeks. Patients with no response after 3
weeks cross over to arm I after a 48-hour washout period.
Depression and neurocognitive function are assessed at baseline, 3 weeks, and end of study.
PROJECTED ACCRUAL: A total of 177 patients (approximately 88 per treatment arm) will be
accrued for this study within 3 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Response rate as measured by Wechsler Intelligence Scale for Children-III (WISC III) subtest: Coding, Symbol Search and Digit Span at baseline, and 3 weeks after the start of study treatment
Margaret Booth-Jones, PhD
University of South Florida
United States: Data and Safety Monitoring Board
|CCOP - Florida Pediatric||Tampa, Florida 33682-7757|
|Sacred Heart Children's Hospital||Pensacola, Florida 32504|
|Wilford Hall Medical Center||Lackland Air Force Base, Texas 78236-5300|
|University of Florida Shands Cancer Center||Gainesville, Florida 32610-0232|
|William Beaumont Hospital - Royal Oak Campus||Royal Oak, Michigan 48073|
|MBCCOP-Medical College of Georgia Cancer Center||Augusta, Georgia 30912-4000|
|MBCCOP - South Texas Pediatrics||San Antonio, Texas 78229-3900|
|St. Joseph's Children's Hospital of Tampa||Tampa, Florida 33677-4227|
|CHRISTUS Santa Rosa Children's Hospital||San Antonio, Texas 78207|