Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors

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.

Detailed description: OBJECTIVES:
  -  Determine the effect of d-methylphenidate on fatigue in patients receiving radiotherapy for primary or metastatic brain tumors.
  -  Determine the effect of this drug on the quality of life of these patients.
  -  Determine the effect of this drug on depression in these patients.
  -  Determine the effect of this drug on global neurocognitive function, including attention and concentration, memory, language, visuospatial skills, and executive function, in these patients.
  OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified by tumor type (primary vs metastatic), treatment (radiotherapy vs radiotherapy and chemotherapy), and Karnofsky performance status (70% or 80% vs 90% or 100%). Patients are randomized to one of two treatment arms.
  All patients undergo radiotherapy over weeks 1-4.
  -  Arm I: Patients receive oral d-methylphenidate twice daily on weeks 1-12.
  -  Arm II: Patients receive oral placebo twice daily on weeks 1-12. In both arms, quality of life is assessed at baseline, at the end of radiotherapy, and at 4, 8, and 12 weeks after radiotherapy.
  Patients are followed at 4 weeks.
  PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study within 18 months.

Eligibility: 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 stereotactic radiosurgery)
  -  No concurrent craniospinal axis radiotherapy
  Surgery:
  -  Not specified
  Other:
  -  No prior or concurrent medications for attention deficit disorder, anxiety disorder, schizophrenia, or substance abuse
  -  No concurrent anti-depressants

Relevance to patient case: not relevant