Trial Information

Double-Blind Randomized Trial of Methylphenidate for Alleviation of Fatigue and Lethargy Associated With Interferon Alpha 2b

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.

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.

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