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

Alternate Title

Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Supportive care Closed 21 to 65 NCI, Pharmaceutical / Industry UCLA-0206017 CEPHALON-UCLA-0206017, NCI-G02-2133, NCT00052286

Objectives

1. Compare the effectiveness of low-dose vs high-dose modafinil for treatment of fatigue and neurobehavioral dysfunction in patients with primary brain tumors.
2. Determine the safety of this drug in these patients.
3. Compare quality of life of patients treated with 2 different doses of this drug.

Entry Criteria

Disease Characteristics:

• Diagnosis of primary malignant brain tumor and receiving treatment in the UCLA Neuro-Oncology Program
  • Nonmalignant cerebral tumors also allowed



• Received some combination of prior therapy for disease, including neurosurgical resection, radiotherapy, and cytotoxic or cytostatic chemotherapy



• Mild to severe fatigue and/or attention/memory impairment, as measured by the Clinical Global Impression of Severity Scale

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• No concurrent irinotecan
• No concurrent participation in UCLA experimental chemotherapy trials
• Concurrent conventional chemotherapy (e.g., carboplatin, lomustine, temozolomide) allowed

Endocrine therapy

• Concurrent glucocorticoids (e.g., dexamethasone) allowed
• Concurrent tamoxifen allowed

Radiotherapy

• See Disease Characteristics

Surgery

• See Disease Characteristics

Other

• No prior modafinil
• At least 30 days since prior stimulants (e.g., amphetamines or methylphenidate)
• No concurrent experimental anticancer medication
• No concurrent tricyclic antidepressants and/or monoamine oxidase inhibitors
• Concurrent anticonvulsants allowed
• Concurrent isotretinoin allowed

Patient Characteristics:

Age

• 21 to 65

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin no greater than 2.5 times normal
• SGOT no greater than 2.5 times normal

Renal

• Creatinine no greater than 1.5 mg/dL

Other

• Able to speak English
• Capable of completing self-rating scales and one-on-one psychometric tests
• No severe cognitive impairment
• No other terminal illness
• No emergency patients
• No institutional residents
• No prisoners or parolees
• No UCLA students or staff
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

Approximately 30 patients will be accrued for this study.

Outcomes

Neurocognitive functioning as assessed by Trail Making Test, Symbol Digit Modalities Test, and Verbal Fluency at baseline and weeks 1, 3, 4, 8, and 10
Mood as assessed by Hamilton Depression Scale (31 questions) at baseline and weeks 3, 4, 8, and 10
Fatigue level as assessed by Fatigue Severity Scale, Modified Fatigue Impact Scale, and Visual Analogue Fatigue Scale at baseline and weeks 1, 3, 4, 5, 7, 8, 9, and 10

Global functioning as assessed by Clinical Global Impression of Severity and Clinical Global Impression of Change at baseline and weeks 1, 3, 4, 5, 7, 8, 9, and 10

Outline

This is a randomized, double-blind, parallel-group study. Patients are randomized to 1 of 2 arms.

• Randomized phase:
  • Arm I: Patients receive oral high-dose modafinil twice daily.
  
  
  
  • Arm II: Patients receive oral low-dose modafinil twice daily.

    In both arms, treatment in this phase continues for 3 weeks followed by a 1-week washout period.

  
  
  



• Extended treatment phase:After the 1-week washout period, all patients receive oral low-dose modafinil once daily on days 1-3. The dose is then titrated to an optimal level and administered in divided doses.

Fatigue, neurobehavioral dysfunction, and quality of life are assessed during the randomized phase at baseline and on days 7 and 21 and then during the extended treatment phase at baseline and on days 28 and 56.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Timothy Cloughesy, MD, Principal investigator		Ph: 310-825-5321; 888-798-0719 Email: tcloughesy@mednet.ucla.edu

Registry Information
Official Title		A Pilot Study of Modafinil for Treatment of Fatigue and Neurobehavioral Dysfunction in Adult Brain Tumor Patients
Trial Start Date		2002-09-13
Registered in ClinicalTrials.gov		NCT00052286
Date Submitted to PDQ		2002-09-25
Information Last Verified		2006-04-11
NCI Grant/Contract Number		CA16042

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