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

Sponsor:	University of South Florida
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00069927

Purpose

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.

Condition	Intervention	Phase
Depression Neurotoxicity Unspecified Childhood Solid Tumor, Protocol Specific	Drug: dextroamphetamine-amphetamine Drug: methylphenidate hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Supportive Care
Official Title:	Adderall-XR Versus Concerta For Cancer Treatment-Related Neurocognitive Sequelae And Depression In Pediatric Patients: A Randomized Phase II Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Depression Memory Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Dextroamphetamine sulfate Dextroamphetamine Amphetamine sulfate Methylphenidate Methylphenidate hydrochloride Amphetamine Methamphetamine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	177
Study Start Date:	August 2003
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069927

Locations

United States, Florida
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0296
Sacred Heart Children's Hospital
Pensacola, Florida, United States, 32504
CCOP - Florida Pediatric
Tampa, Florida, United States, 33682-7757
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, United States, 33677-4227
United States, Georgia
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912-4000
United States, Michigan
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, Texas
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States, 78236-5300
CHRISTUS Santa Rosa Children's Hospital
San Antonio, Texas, United States, 78207
MBCCOP - South Texas Pediatrics
San Antonio, Texas, United States, 78229-3900

Sponsors and Collaborators

University of South Florida

National Cancer Institute (NCI)

Investigators

Study Chair:

Margaret Booth-Jones, PhD

University of South Florida

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00069927 History of Changes
Other Study ID Numbers:	CDR0000301614, MCC-0201, NCI-5899
Study First Received:	October 3, 2003
Last Updated:	September 11, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified childhood solid tumor, protocol specific
depression
neurotoxicity

Additional relevant MeSH terms:

Depression
Depressive Disorder
Neurotoxicity Syndromes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Nervous System Diseases
Poisoning
Substance-Related Disorders
Amphetamine
Methamphetamine
Dextroamphetamine
Methylphenidate
Adderall
Central Nervous System Stimulants

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012