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Adderall-XR Versus Concerta For Cancer Treatment-Related Neurocognitive Sequelae And Depression In Pediatric Patients: A Randomized Phase II Study


Phase 2
6 Years
17 Years
Not Enrolling
Both
Depression, Neurotoxicity, Unspecified Childhood Solid Tumor, Protocol Specific

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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 PediatricTampa, Florida  33682-7757
Sacred Heart Children's HospitalPensacola, Florida  32504
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
MBCCOP-Medical College of Georgia Cancer CenterAugusta, Georgia  30912-4000
MBCCOP - South Texas PediatricsSan Antonio, Texas  78229-3900
St. Joseph's Children's Hospital of TampaTampa, Florida  33677-4227
CHRISTUS Santa Rosa Children's HospitalSan Antonio, Texas  78207