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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00069927 |
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 |
Cancer-Related Problem/Condition Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: dextroamphetamine-amphetamine Drug: methylphenidate hydrochloride |
Phase II |
MedlinePlus related topics: | Cancer Depression Memory |
Drug Information available for: | Methylphenidate hydrochloride Methylphenidate Dextroamphetamine Dextroamphetamine sulfate Amphetamine Amphetamine sulfate |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Active Control |
Official Title: | Adderall-XR Versus Concerta For Cancer Treatment-Related Neurocognitive Sequelae And Depression In Pediatric Patients: A Randomized Phase II Study |
Estimated Enrollment: | 177 |
Study Start Date: | August 2003 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study.
Patients are randomized to 1 of 2 treatment arms.
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.
Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of a malignancy and received prior CNS treatment (e.g., surgery and/or radiotherapy and/or intrathecal chemotherapy)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No seizures not controlled by antiepileptic drugs
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Florida | |||||
CCOP - Florida Pediatric | |||||
Tampa, Florida, United States, 33682-7757 | |||||
Sacred Heart Children's Hospital | |||||
Pensacola, Florida, United States, 32504 | |||||
St. Joseph's Children's Hospital of Tampa | |||||
Tampa, Florida, United States, 33677-4227 | |||||
University of Florida Shands Cancer Center | |||||
Gainesville, Florida, United States, 32610-0296 | |||||
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 | |||||
CHRISTUS Santa Rosa Children's Hospital | |||||
San Antonio, Texas, United States, 78207 | |||||
MBCCOP - South Texas Pediatrics | |||||
San Antonio, Texas, United States, 78229-3900 | |||||
Wilford Hall Medical Center | |||||
Lackland Air Force Base, Texas, United States, 78236-5300 |
H. Lee Moffitt Cancer Center and Research Institute |
National Cancer Institute (NCI) |
Study Chair: | Margaret Booth-Jones, PhD | H. Lee Moffitt Cancer Center and Research Institute |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000301614, MCC-0201, NCI-5899 |
First Received: | October 3, 2003 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00069927 |
Health Authority: | United States: Federal Government |
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