Adderall-XR Versus Concerta For Cancer Treatment-Related Neurocognitive Sequelae And Depression In Pediatric Patients: A Randomized Phase II Study
6 Years
17 Years
Both
Depression, Neurotoxicity, Unspecified Childhood Solid Tumor, Protocol Specific
Trial Information
Adderall-XR Versus Concerta For Cancer Treatment-Related Neurocognitive Sequelae And Depression In Pediatric Patients: A Randomized Phase II Study
OBJECTIVES:
- Compare the response rates in pediatric cancer patients with treatment-related
neurocognitive sequelae treated with dextroamphetamine-amphetamine (Adderall-XR®) vs
methylphenidate (Concerta®).
- 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.
Inclusion Criteria
INCLUSION CRITERIA:
- Between the ages of 6-17 at the time of study participation.
- Have a diagnosis of any malignancy that required CNS treatment such as surgery and/or
irradiation and/or intrathecal chemotherapy. (Patients treated with systemic
chemotherapy alone are not eligible to participate)
- Off treatment and cancer free for a minimum of 6 months.
- Have a proficiency in English.
EXCLUSION CRITERIA:
- Patients with an estimated intelligence quotient (IQ) of less than 65 (based on the
Wide Range Achievement Test (WRAT-3) Reading subtest) are not eligible to continue on
study.
- At least one standard deviation below the level of performance predicted by their IQ
on at least 2 of the 3 WISC-III subtests.
- Diagnosed with Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity
Disorder (ADHD) prior to their cancer diagnosis.
- Currently taking antidepressants, antipsychotics, or other stimulants.
- Are blind.
- Have glaucoma.
- Family history of motor and phonic tics or Tourette's syndrome.
- Have seizures not controlled by antiepileptic drugs. (Note: Patients who are not
experiencing seizure activity, having been on a stable dose of an antiepileptic drug
for at least 12 weeks may participate)
- Taking a monoamine oxidase (MAO) inhibitor.
- Have a history of cardiovascular disease, uncontrolled hypertension or
hyperthyroidism.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
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
Outcome Time Frame:
12 weeks
Safety Issue:
No
Principal Investigator
Margaret Booth-Jones, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University of South Florida
Authority:
United States: Data and Safety Monitoring Board
Study ID:
SCUSF 0201
NCT ID:
NCT00069927
Start Date:
August 2003
Completion Date:
September 2006
Related Keywords:
- Depression
- Neurotoxicity
- Unspecified Childhood Solid Tumor, Protocol Specific
- unspecified childhood solid tumor, protocol specific
- depression
- neurotoxicity
- Depression
- Depressive Disorder
- Neurotoxicity Syndromes
Name | Location |
|---|---|
| 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 |
