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

• Status: Terminated
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest Baptist Health; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Methylphenidate

Criteria

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