Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children Who Have Problems With Memory, Attention, Thinking, and Depression Caused By Cancer Treatment - Tabular View

Tracking Information

First Received Date ^ICMJE

October 3, 2003

Last Updated Date

May 9, 2009

Start Date ^ICMJE

August 2003

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00069927 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children Who Have Problems With Memory, Attention, Thinking, and Depression Caused By Cancer Treatment

Official Title ^ICMJE

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

Brief 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.

Detailed Description

OBJECTIVES:

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Randomized, Active Control

Condition ^ICMJE

Depression
Neurotoxicity
Unspecified Childhood Solid Tumor, Protocol Specific

Intervention ^ICMJE

Drug: dextroamphetamine-amphetamine
Drug: methylphenidate hydrochloride

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

177

Completion Date

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Diagnosis of a malignancy and received prior CNS treatment (e.g., surgery and/or radiotherapy and/or intrathecal chemotherapy)
- Patients treated with prior systemic chemotherapy alone are not eligible
- At least 6 months since prior treatment
Cancer-free for at least 6 months
Neurocognitive function at least 1 standard deviation below the level of performance predicted by patient's IQ on at least 2 of 3 WISC®-III subtests*
No diagnosis of attention deficit disorder or attention-deficit hyperactivity disorder before cancer diagnosis NOTE: *Patients who are not eligible for randomization based on test results may be retested every 3 months

PATIENT CHARACTERISTICS:

Age

6 to 17

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Cardiovascular

No history of cardiovascular disease or uncontrolled hypertension

Other

No history of hyperthyroidism
Estimated IQ of at least 65 (based on the WRAT-3™ reading subtest)
Not blind
No glaucoma
No family history of motor and phonic tics or Tourette's syndrome
No seizures not controlled by antiepileptic drugs
- Patients not currently experiencing seizures and who have been on a stable dose of antiepileptic drugs for at least 12 weeks are eligible
Proficient in English
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics

Surgery

See Disease Characteristics

Other

No concurrent antidepressants, antipsychotics, or other stimulants
No concurrent monoamine oxidase inhibitors

Gender

Both

Ages

6 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00069927

Responsible Party

Study ID Numbers ^ICMJE

CDR0000301614, MCC-0201, NCI-5899

Study Sponsor ^ICMJE

H. Lee Moffitt Cancer Center and Research Institute

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Margaret Booth-Jones, PhD

H. Lee Moffitt Cancer Center and Research Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP