Methylphenidate in Treating Patients With Melanoma

Condition(s) targeted: Fatigue; Quality of Life; Unspecified Adult Solid Tumor, Protocol Specific

Intervention: methylphenidate hydrochloride (Drug); fatigue assessment and management (Procedure); quality-of-life assessment (Procedure)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Eastern Cooperative Oncology Group

Official(s) and/or principal investigator(s):
Paul R. Hutson, PharmD, Study Chair, Affiliation: University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

RATIONALE: Methylphenidate may relieve some of the side effects of chemotherapy in patients with melanoma. It is not known whether receiving methylphenidate is more effective than receiving no further therapy in treating patients with melanoma. PURPOSE: Randomized phase III trial to determine if methylphenidate is more effective than no further therapy for the relief of fatigue and drowsiness in treating patients with melanoma who have received high-dose interferon alfa for 8-24 weeks.

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

Study design: Supportive Care, Randomized, Double-Blind, Placebo Control

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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) 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 PRIOR CONCURRENT THERAPY: See Disease Characteristics No monoamine oxidase inhibitors within 2 months

MBCCOP - San Juan, San Juan 00927-5800, Puerto Rico

Pretoria Academic Hospitals, Pretoria 0001, South Africa

CCOP - Scottsdale Oncology Program, Scottsdale, Arizona 85259-5404, United States

Stanford University Medical Center, Stanford, California 94305-5408, United States

Veterans Affairs Medical Center - Palo Alto, Palo Alto, California 94304, United States

CCOP - Colorado Cancer Research Program, Inc., Denver, Colorado 80209-5031, United States

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612-9497, United States

Veterans Affairs Medical Center - Gainsville, Gainesville, Florida 32608-1197, United States

Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida 33612, United States

Emory University Hospital - Atlanta, Atlanta, Georgia 30322, United States

Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia 30033, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

CCOP - Central Illinois, Decatur, Illinois 62526, United States

CCOP - Evanston, Evanston, Illinois 60201, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois 61602, United States

Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois 60611-3013, United States

Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois 60611, United States

Indiana University Cancer Center, Indianapolis, Indiana 46202-5289, United States

Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis, Indiana 46202, United States

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403-1206, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309-1016, United States

CCOP - Ochsner, New Orleans, Louisiana 70121, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States

New England Medical Center Hospital, Boston, Massachusetts 02111, United States

CCOP - Ann Arbor Regional, Ann Arbor, Michigan 48106, United States

CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States

CCOP - Duluth, Duluth, Minnesota 55805, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota 55417, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68131, United States

Cancer Institute of New Jersey, New Brunswick, New Jersey 08901, United States

CCOP - Northern New Jersey, Hackensack, New Jersey 07601, United States

Veterans Affairs Medical Center - East Orange, East Orange, New Jersey 07018-1095, United States

Albert Einstein Comprehensive Cancer Center, Bronx, New York 10461, United States

MBCCOP-Our Lady of Mercy Cancer Center, Bronx, New York 10466, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York 10016, United States

University of Rochester Cancer Center, Rochester, New York 14642, United States

Veterans Affairs Medical Center - Brooklyn, Brooklyn, New York 11209, United States

Veterans Affairs Medical Center - New York, New York, New York 10010, United States

CCOP - Merit Care Hospital, Fargo, North Dakota 58122, United States

CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio 43623-3456, United States

Ireland Cancer Center, Cleveland, Ohio 44106-5065, United States

CCOP - Oklahoma, Tulsa, Oklahoma 74136, United States

CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania 17822-2001, United States

CCOP - MainLine Health, Wynnewood, Pennsylvania 19096, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States

Hahnemann University Hospital, Philadelphia, Pennsylvania 19102-1192, United States

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania 19107-5541, United States

University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania 19104-4283, United States

Veterans Affairs Medical Center - Pittsburgh, Pittsburgh, Pennsylvania 15240, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57104, United States

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232-6838, United States

Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus, Nashville, Tennessee 37212, United States

University of Texas - MD Anderson Cancer Center, Houston, Texas 77030-4009, United States

CCOP - Marshfield Medical Research and Education Foundation, Marshfield, Wisconsin 54449, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53792-6164, United States

Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin 53295, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: June 1999
Last updated: October 25, 2007