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A Phase III, Double-Blind, Prospective Randomized Clinical Trial of the Effect of D-threo-methylphenidate HCl (d-MPH) on Quality of Life in Brain Tumor Patients Receiving Radiation Therapy


Phase 3
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Depression, Fatigue, Quality of Life

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Trial Information

A Phase III, Double-Blind, Prospective Randomized Clinical Trial of the Effect of D-threo-methylphenidate HCl (d-MPH) on Quality of Life in Brain Tumor Patients Receiving Radiation Therapy


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Edward G. Shaw, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000069227

NCT ID:

NCT00031798

Start Date:

April 2002

Completion Date:

May 2006

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Cognitive/Functional Effects
  • Depression
  • Fatigue
  • Quality of Life
  • fatigue
  • depression
  • quality of life
  • cognitive/functional effects
  • recurrent adult brain tumor
  • adult brain stem glioma
  • adult glioblastoma
  • adult tumors metastatic to brain
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • adult meningioma
  • adult anaplastic ependymoma
  • adult myxopapillary ependymoma
  • adult ependymoblastoma
  • adult pilocytic astrocytoma
  • adult subependymoma
  • adult grade III meningioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult grade II meningioma
  • Brain Neoplasms
  • Depression
  • Depressive Disorder
  • Fatigue
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - ColumbusColumbus, Ohio  43206
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112