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

Alternate Title

Methylphenidate in Treating Patients With Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	18 and over	NCI	E-2Z96 NCI-P98-0130, NCT00003266

Objectives

I.  Determine whether methylphenidate decreases fatigue and lethargy in cancer 
patients receiving interferon alfa.

II.  Determine whether the use of methylphenidate in this patient population 
decreases the number of dose reductions of interferon alfa due to toxicities 
other than myelosuppression or elevated liver function tests.

III.  Assess whether efficacy or toxicity of methylphenidate in this patient 
population is concentration dependent.

IV.  Compare the fatigue subscale and the proposed Brief Fatigue Inventory.

Entry Criteria

Disease Characteristics:

On interferon alfa-2b treatment for at least 8 weeks
 Dose must be stable for 2 weeks prior to and during study

Fatigue level at least 4 on the Symptom and Fatigue Self Evaluation Form (0
none, 10 worst possible)

Prior/Concurrent Therapy:

See Disease Characteristics
No monoamine oxidase inhibitors within 2 months

Patient Characteristics:

Age:
 18 and over

Performance status:
 Not specified

Life expectancy:
 More than 4 weeks

Hematopoietic:
 Hematocrit at least 30%

Hepatic:
 Not specified

Renal:
 Creatinine no greater than 2.0 mg/dL

Other:
 No history of any of the following:
  Chronic use of anticonvulsants
  Seizure disorder
  Motor tics
  Glaucoma
  Family history or diagnosis of Tourette's disorder
 No allergic reaction or hypersensitivity to methylphenidate
 Cognitively able to participate
 Not incarcerated
 Not pregnant or nursing
 Fertile patients must use effective contraception

Expected Enrollment

A total of 200 patients will be accrued into this study within 39 months.

Outline

This is a randomized, double-blind, placebo-controlled, two arm study.  
Patients are stratified according to initial fatigue level (high vs moderate), 
and treatment with tumor vaccine (yes vs no).  Patients are randomized to one 
of two treatment arms.

Arm I: Patients receive oral methylphenidate twice daily.

Arm II: Patients receive oral placebo twice daily.  

Treatment is continued for 21 consecutive days with dose escalations as 
tolerated and as needed by patient judgement, followed by an additional week 
to evaluate the effect of drug withdrawal.  Patients are contacted by 
telephone at least twice weekly during the 21 day treatment and 7 day washout 
phase to assess adverse or rebound effects.

Before the study begins and at weekly clinic visits for the 4 week study 
period, patients complete a series of questionnaires to measure mood, levels 
of fatigue and lethargy, and sense of well being.  Patients also keep a short 
daily diary of study medication doses and degree of tiredness.

Patients are followed every 3 months for 2 years, then every 6 months for the 
next 3 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Paul Hutson, PharmD, Protocol chair		Ph: 608-263-8600; 800-622-8922

Registry Information
Official Title		Double-Blind Randomized Trial of Methylphenidate for Alleviation of Fatigue and Lethargy Associated With Interferon Alpha 2b
Trial Start Date		1999-06-10
Trial Completion Date		2002-05-10
Registered in ClinicalTrials.gov		NCT00003266
Date Submitted to PDQ		1998-03-16
Information Last Verified		2008-03-25
NCI Grant/Contract Number		CA21115

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