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Methylphenidate in Treating Patients With Melanoma

Sponsor
Eastern Cooperative Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00003266
Collaborator
National Cancer Institute (NCI) (NIH)
200
Enrollment
59
Locations
3.4
Patients Per Site

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: methylphenidate hydrochloride
  • Procedure: quality-of-life assessment
 Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Masking:
Double
Primary Purpose:
Supportive Care
Official Title:
Double-Blind Randomized Trial of Methylphenidate for Alleviation of Fatigue and Lethargy Associated With Interferon Alpha 2b
Study Start Date :
Jun 1, 1999
Actual Primary Completion Date :
May 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CCOP - Scottsdale Oncology Program Scottsdale Arizona United States 85259-5404
    2 Veterans Affairs Medical Center - Palo Alto Palo Alto California United States 94304
    3 Stanford University Medical Center Stanford California United States 94305-5408
    4 CCOP - Colorado Cancer Research Program, Inc. Denver Colorado United States 80209-5031
    5 Veterans Affairs Medical Center - Gainsville Gainesville Florida United States 32608-1197
    6 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612-9497
    7 Veterans Affairs Medical Center - Tampa (Haley) Tampa Florida United States 33612
    8 Emory University Hospital - Atlanta Atlanta Georgia United States 30322
    9 Veterans Affairs Medical Center - Atlanta (Decatur) Decatur Georgia United States 30033
    10 Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago Illinois United States 60611-3013
    11 Veterans Affairs Medical Center - Lakeside Chicago Chicago Illinois United States 60611
    12 CCOP - Central Illinois Decatur Illinois United States 62526
    13 CCOP - Evanston Evanston Illinois United States 60201
    14 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61602
    15 CCOP - Carle Cancer Center Urbana Illinois United States 61801
    16 Indiana University Cancer Center Indianapolis Indiana United States 46202-5289
    17 Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis Indiana United States 46202
    18 CCOP - Cedar Rapids Oncology Project Cedar Rapids Iowa United States 52403-1206
    19 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309-1016
    20 CCOP - Ochsner New Orleans Louisiana United States 70121
    21 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231-2410
    22 New England Medical Center Hospital Boston Massachusetts United States 02111
    23 CCOP - Ann Arbor Regional Ann Arbor Michigan United States 48106
    24 CCOP - Kalamazoo Kalamazoo Michigan United States 49007-3731
    25 CCOP - Duluth Duluth Minnesota United States 55805
    26 Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota United States 55417
    27 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
    28 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
    29 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68131
    30 Veterans Affairs Medical Center - East Orange East Orange New Jersey United States 07018-1095
    31 CCOP - Northern New Jersey Hackensack New Jersey United States 07601
    32 Cancer Institute of New Jersey New Brunswick New Jersey United States 08901
    33 Albert Einstein Comprehensive Cancer Center Bronx New York United States 10461
    34 MBCCOP-Our Lady of Mercy Cancer Center Bronx New York United States 10466
    35 Veterans Affairs Medical Center - Brooklyn Brooklyn New York United States 11209
    36 Veterans Affairs Medical Center - New York New York New York United States 10010
    37 NYU School of Medicine's Kaplan Comprehensive Cancer Center New York New York United States 10016
    38 University of Rochester Cancer Center Rochester New York United States 14642
    39 CCOP - Merit Care Hospital Fargo North Dakota United States 58122
    40 Ireland Cancer Center Cleveland Ohio United States 44106-5065
    41 CCOP - Toledo Community Hospital Oncology Program Toledo Ohio United States 43623-3456
    42 CCOP - Oklahoma Tulsa Oklahoma United States 74136
    43 CCOP - Geisinger Clinic and Medical Center Danville Pennsylvania United States 17822-2001
    44 Hahnemann University Hospital Philadelphia Pennsylvania United States 19102-1192
    45 University of Pennsylvania Cancer Center Philadelphia Pennsylvania United States 19104-4283
    46 Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107-5541
    47 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    48 Veterans Affairs Medical Center - Pittsburgh Pittsburgh Pennsylvania United States 15240
    49 CCOP - MainLine Health Wynnewood Pennsylvania United States 19096
    50 CCOP - Sioux Community Cancer Consortium Sioux Falls South Dakota United States 57104
    51 Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus Nashville Tennessee United States 37212
    52 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232-6838
    53 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030-4009
    54 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792-6164
    55 CCOP - Marshfield Medical Research and Education Foundation Marshfield Wisconsin United States 54449
    56 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    57 Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee Wisconsin United States 53295
    58 MBCCOP - San Juan San Juan Puerto Rico 00927-5800
    59 Pretoria Academic Hospitals Pretoria South Africa 0001

    Sponsors and Collaborators

    • Eastern Cooperative Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Paul R. Hutson, PharmD, University of Wisconsin, Madison

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00003266
    Other Study ID Numbers:
    • CDR0000066161
    • E-2Z96
    • NCI-P98-0130
    First Posted:
    Oct 28, 2003
    Last Update Posted:
    Nov 2, 2020
    Last Verified:
    Mar 1, 2008
    Keywords provided by , ,
    unspecified adult solid tumor, protocol specific
    fatigue
    Additional relevant MeSH terms:
    Fatigue
    Methylphenidate

    Study Results

    No Results Posted as of Nov 2, 2020