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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00031798
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Wake Forest University Health Sciences
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Edward G. Shaw, MD
Principal Investigator Affiliation Wake Forest University Health Sciences
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Terminated
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Depression, Fatigue, Quality of Life
Additional Details

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.#46;metastatic), treatment (radiotherapy vs.#46; radiotherapy and chemotherapy), and Karnofsky performance status (70% or 80% vs.#46;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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

CCOP - Western Regional, Arizona, Phoenix, Arizona

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Address

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Phoenix, Arizona, 85006-2726

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Address

CCOP - Central Illinois

Decatur, Illinois, 62526

MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana

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MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112

Goldsboro, North Carolina

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Address

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, 27534-9479

Winston-Salem, North Carolina

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Address

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1030

CCOP - Columbus, Columbus, Ohio

Status

Address

CCOP - Columbus

Columbus, Ohio, 43206

CCOP - Upstate Carolina, Spartanburg, South Carolina

Status

Address

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303

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