| Phase II Randomized Study of Dextroamphetamine-Amphetamine Versus Methylphenidate in Pediatric Cancer Patients With Treatment-Related Neurocognitive Sequelae and Depression
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children Who Have Problems With Memory, Attention, Thinking, and Depression Caused By Cancer Treatment
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II | Supportive care | Completed | 6 to 17 | MCC-0201
NCI-5899, HLMCC 0201, NCT00069927 |
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.
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] Prior/Concurrent Therapy:
Biologic therapy Chemotherapy - See Disease Characteristics
Endocrine therapy Radiotherapy - See Disease Characteristics
Surgery - See Disease Characteristics
Other - No concurrent antidepressants, antipsychotics, or other stimulants
- No concurrent monoamine oxidase inhibitors
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic Hepatic Renal 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
Expected Enrollment 177A total of 177 patients (approximately 88 per treatment arm) will be accrued for this study within 3 years. Outcomes Primary Outcome(s)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(s)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
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.
Trial Contact Information
Trial Lead Organizations H. Lee Moffitt Cancer Center CCOP Research Base  | | | | Margaret Booth-Jones, PhD, Protocol chair | | | |
| Registry Information | | | Official Title | | Adderall-XR Versus Concerta For Cancer Treatment-Related Neurocognitive Sequelae And Depression In Pediatric Patients: A Randomized Phase II Study | | | Trial Start Date | | 2003-08-01 | | | Trial Completion Date | | 2006-06-12 | | | Registered in ClinicalTrials.gov | | NCT00069927 | | | Date Submitted to PDQ | | 2003-03-27 | | | Information Last Verified | | 2006-07-26 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
