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Pilot Randomized Study of Modafinil for Treatment of Fatigue and Neurobehavioral Dysfunction in Patients With Primary Brain Tumors

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

Compare the effectiveness of low-dose vs high-dose modafinil for treatment of fatigue and neurobehavioral dysfunction in patients with primary brain tumors.
Determine the safety of this drug in these patients.
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

Primary Outcome(s)

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

Secondary Outcome(s)

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

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.