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Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children With Depression and Problems With Memory, Attention, and Thinking Caused By Cancer Treatment Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children With Depression and Problems With Memory, Attention, and Thinking Caused By Cancer Treatment conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children With Depression and Problems With Memory, Attention, and Thinking Caused By Cancer Treatment Clinical research trials and Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children With Depression and Problems With Memory, Attention, and Thinking Caused By Cancer Treatment healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children With Depression and Problems With Memory, Attention, and Thinking Caused By Cancer Treatment. Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children With Depression and Problems With Memory, Attention, and Thinking Caused By Cancer Treatment Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children With Depression and Problems With Memory, Attention, and Thinking Caused By Cancer Treatment clinical trial. Participants typically obtain the most effective healthcare available for their Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children With Depression and Problems With Memory, Attention, and Thinking Caused By Cancer Treatment condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children With Depression and Problems With Memory, Attention, and Thinking Caused By Cancer Treatment  Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children With Depression and Problems With Memory, Attention, and Thinking Caused By Cancer Treatment
Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children With Depression and Problems With Memory, Attention, and Thinking Caused By Cancer Treatment
For Condition: unspecified childhood solid tumor, protocol specific,neurotoxicity,Depression
Status: Recruiting
Sponsor(s): H. Lee Moffitt Cancer Center and Research Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Stimulant drugs such as dextroamphetamine-amphetamine and methylphenidate may decrease depression and may help improve memory, attention, and thinking problems caused by central nervous system (CNS) treatment for cancer. PURPOSE: Randomizedphase II trial to compare the effectiveness of dextroamphetamine-amphetamine with that of methylphenidate in treating depression and problems with memory, attention, and thinking in children who have undergone CNS treatment for cancer.
Details: OBJECTIVES: - Compare the response rates in pediatric cancer patients with treatment-related neurocognitive sequelae and depression 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 6 Years/17 Years
Genders: Both
Protocol Entry 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 Other - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MargaretBooth-Jones, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville, Florida, 32610-0296
United States
Recruiting Stephen Hunger 352-392-9393
MBCCOP - South Texas Pediatrics *Recruiting*
San Antonio, Texas, 78229-3900
United States
Recruiting Anthony Infante 210-567-5265
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Tampa Children's Hospital *Recruiting*
Tampa, Florida, 33677-4227
United States
Recruiting Cameron Tebbi 813-870-4252
Children's Hospital of Southwest Florida *Recruiting*
Ft. Myers, Florida, 33908
United States
Recruiting Emad Salman 239-432-3333
CCOP - Florida Pediatric *Recruiting*
Tampa, Florida, 33682-7757
United States
Recruiting James Talbert 352-392-3718
Additional Information:
Study ID Numbers: CDR0000301614; NCI-5899,MCC-0201
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069927
Other Neurotoxicity Studies:
1. Treatment of Depression in Youth with Bipolar Disorders
2. Cognitive Behavioral Therapy for the Treatment of Seasonal Affective Disorder (SAD)
3. Examination of a Soy-Based Supplement for Major Depression
4. Reducing Depression in Caregivers to People with Dementia
5. Prevention of Suicide in the Elderly
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Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children With Depression and Problems With Memory, Attention, and Thinking Caused By Cancer Treatment
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