Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care, Treatment	Closed	18 and over	NCI	CCCWFU-97600 NCI-P02-0211, NCT00031798

Objectives

1. Determine the effect of d-methylphenidate on fatigue in patients receiving radiotherapy for primary or metastatic brain tumors.
2. Determine the effect of this drug on the quality of life of these patients.
3. Determine the effect of this drug on depression in these patients.
4. Determine the effect of this drug on global neurocognitive function, including attention and concentration, memory, language, visuospatial skills, and executive function, in these patients.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• At least 3 months

Hematopoietic:

• WBC ≥ 1,500/mm³
• Hemoglobin ≥ 10.0 g/dL
• Platelet count ≥ 75,000/mm³

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

Expected Enrollment

A total of 200 patients (100 per treatment arm) will be accrued for this study within 18 months.

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.

Trial Contact Information

Trial Lead Organizations

Wake Forest University Comprehensive Cancer Center

Edward Shaw, MD, Protocol chair		Ph: 336-713-6506; 800-446-2255 Email: eshaw@wfubmc.edu

Registry Information
Official Title		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
Trial Start Date		2002-04-01
Registered in ClinicalTrials.gov		NCT00031798
Date Submitted to PDQ		2002-01-15
Information Last Verified		2005-05-04
NCI Grant/Contract Number		CA12197

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