Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression

University of South Florida

Status and phase: Terminated; Phase 2

Conditions: Depression; Neurotoxicity; Unspecified Childhood Solid Tumor, Protocol Specific

Treatments: Drug: Concerta®; Drug: Adderall-XR®

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00069927

SCUSF 0201

SCUSF-0201 (Other Identifier)

HLMCC-0201 (Other Identifier)

U10CA081920 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Arm 1- Adderall- XR®

Experimental group

Description:

Adderall-XR® 1 10 mg/day for 3-12 weeks depending on subject's response

Treatment:

Drug: Adderall-XR®

Drug: Concerta®

Arm II Concerta®

Experimental group

Description:

Concerta ® 18 mg/day for 3-12 weeks depending on subject's response

Treatment:

Drug: Adderall-XR®

Drug: Concerta®