Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and … (NCT00069927) | Clinical Trial Compass
TerminatedPhase 2
Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression
Stopped: Only 12 subjects enrolled. DSMB recommended closing due to lack of feasibility
United States12 participantsStarted 2003-08
Plain-language summary
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.
Who can participate
Age range
6 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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