Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children Who Have Problems With Memory, Attention, Thinking, and Depression Caused By Cancer Treatment
RATIONALE: Stimulant drugs such as dextroamphetamine-amphetamine and methylphenidate may help improve memory, attention, and thinking problems caused by central nervous system (CNS) treatment for cancer, and may help decrease depression.
PURPOSE: This randomized phase II trial is studying dextroamphetamine-amphetamine to see how well it works compared to methylphenidate in treating depression and problems with memory, attention, and thinking in children who have undergone CNS treatment for cancer. This trial will also study how often depression is seen and if these medications might help.
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: methylphenidate hydrochloride
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||Adderall-XR Versus Concerta For Cancer Treatment-Related Neurocognitive Sequelae And Depression In Pediatric Patients: A Randomized Phase II Study|
- 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
- Durability of response as measured by WISC III subtest: Coding, Symbol Search and Digit Span at 12 weeks after the start of study treatment
- Depression as measured by Children's Depression Inventory Short Version (CDI-S) at baseline, weeks 3 and 12
|Study Start Date:||August 2003|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
- Compare the response rates in pediatric cancer patients with treatment-related neurocognitive sequelae treated with dextroamphetamine-amphetamine vs methylphenidate.
- 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.
|United States, Florida|
|University of Florida Shands Cancer Center|
|Gainesville, Florida, United States, 32610-0296|
|Sacred Heart Children's Hospital|
|Pensacola, Florida, United States, 32504|
|CCOP - Florida Pediatric|
|Tampa, Florida, United States, 33682-7757|
|St. Joseph's Children's Hospital of Tampa|
|Tampa, Florida, United States, 33677-4227|
|United States, Georgia|
|MBCCOP-Medical College of Georgia Cancer Center|
|Augusta, Georgia, United States, 30912-4000|
|United States, Michigan|
|William Beaumont Hospital - Royal Oak Campus|
|Royal Oak, Michigan, United States, 48073|
|United States, Texas|
|Wilford Hall Medical Center|
|Lackland Air Force Base, Texas, United States, 78236-5300|
|CHRISTUS Santa Rosa Children's Hospital|
|San Antonio, Texas, United States, 78207|
|MBCCOP - South Texas Pediatrics|
|San Antonio, Texas, United States, 78229-3900|
|Study Chair:||Margaret Booth-Jones, PhD||University of South Florida|