Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors (NCT00031798) | Clinical Trial Compass
TerminatedPhase 3
Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors
Stopped: low accrual; loss of funding
United StatesStarted 2002-04-01
Plain-language summary
RATIONALE: Methylphenidate may decrease side effects of radiation therapy. It is not yet known if methylphenidate is effective in improving quality of life in patients with primary or metastatic brain tumors.
PURPOSE: Randomized phase III trial to determine the effectiveness of methylphenidate in improving quality of life in patients who have brain tumors and are undergoing radiation therapy.
Who can participate
Age range18 Years – 120 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic brain tumor OR
* Histologically confirmed primary brain tumor
* Glioblastoma multiforme
* Anaplastic astrocytoma
* Anaplastic oligodendroglioma
* Anaplastic mixed oligoastrocytoma
* Low-grade glioma
* Meningioma
* Ependymoma
* Planned external beam cranial radiotherapy (partial or whole brain) with a total dose of at least 25 Gy in at least 10 fractions of 180-300 cGy each
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 70-100%
Life expectancy:
* At least 3 months
Hematopoietic:
* WBC ≥ 1,500/mm\^3
* Hemoglobin ≥ 10.0 g/dL
* Platelet count ≥ 75,000/mm\^3
Hepatic:
* Not specified
Renal:
* Not specified
Cardiovascular:
* No hypertension or other cardiovascular disease requiring antihypertensives and/or other cardiovascular medications
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other serious medical or psychiatric illness that would preclude study participation
* No hypersensitivity to study drug
* No history of steroid psychosis
* No family history of or active Tourette's Syndrome
* No prior or active glaucoma
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Prior or concurrent chemotherapy allowed
Endocrine therapy:
* Concurrent steroids allowed
Radiotherapy:
* See Disease Characteristics
* Prior radiotherapy allowed except to brain (including ster…