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NCT00003266 Clinical Trial

Methylphenidate in Treating Patients With Melanoma

Fatigue Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00003266
Other study ID # CDR0000066161
Secondary ID E-2Z96NCI-P98-01
Status Completed
Phase Phase 3
First received
Last updated
Start date October 12, 1999

Study information
Verified date June 2023
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date
Est. primary completion date May 2002
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Fatigue
  • Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• methylphenidate hydrochloride

Procedure:
• quality-of-life assessment

Locations
Country Name City State
Puerto Rico MBCCOP - San Juan San Juan
South Africa Pretoria Academic Hospitals Pretoria
United States CCOP - Ann Arbor Regional Ann Arbor Michigan
United States Emory University Hospital - Atlanta Atlanta Georgia
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
United States New England Medical Center Hospital Boston Massachusetts
United States Albert Einstein Comprehensive Cancer Center Bronx New York
United States MBCCOP-Our Lady of Mercy Cancer Center Bronx New York
United States Veterans Affairs Medical Center - Brooklyn Brooklyn New York
United States CCOP - Cedar Rapids Oncology Project Cedar Rapids Iowa
United States Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago Illinois
United States Veterans Affairs Medical Center - Lakeside Chicago Chicago Illinois
United States Ireland Cancer Center Cleveland Ohio
United States CCOP - Geisinger Clinic and Medical Center Danville Pennsylvania
United States CCOP - Central Illinois Decatur Illinois
United States Veterans Affairs Medical Center - Atlanta (Decatur) Decatur Georgia
United States CCOP - Colorado Cancer Research Program, Inc. Denver Colorado
United States CCOP - Iowa Oncology Research Association Des Moines Iowa
United States CCOP - Duluth Duluth Minnesota
United States Veterans Affairs Medical Center - East Orange East Orange New Jersey
United States CCOP - Evanston Evanston Illinois
United States CCOP - Merit Care Hospital Fargo North Dakota
United States Veterans Affairs Medical Center - Gainsville Gainesville Florida
United States CCOP - Northern New Jersey Hackensack New Jersey
United States University of Texas - MD Anderson Cancer Center Houston Texas
United States Indiana University Cancer Center Indianapolis Indiana
United States Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis Indiana
United States CCOP - Kalamazoo Kalamazoo Michigan
United States University of Wisconsin Comprehensive Cancer Center Madison Wisconsin
United States CCOP - Marshfield Medical Research and Education Foundation Marshfield Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee Wisconsin
United States Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus Nashville Tennessee
United States Cancer Institute of New Jersey New Brunswick New Jersey
United States CCOP - Ochsner New Orleans Louisiana
United States NYU School of Medicine's Kaplan Comprehensive Cancer Center New York New York
United States Veterans Affairs Medical Center - New York New York New York
United States CCOP - Missouri Valley Cancer Consortium Omaha Nebraska
United States Veterans Affairs Medical Center - Palo Alto Palo Alto California
United States CCOP - Illinois Oncology Research Association Peoria Illinois
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Hahnemann University Hospital Philadelphia Pennsylvania
United States Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania
United States University of Pennsylvania Cancer Center Philadelphia Pennsylvania
United States Veterans Affairs Medical Center - Pittsburgh Pittsburgh Pennsylvania
United States Mayo Clinic Cancer Center Rochester Minnesota
United States University of Rochester Cancer Center Rochester New York
United States CCOP - Metro-Minnesota Saint Louis Park Minnesota
United States CCOP - Scottsdale Oncology Program Scottsdale Arizona
United States CCOP - Sioux Community Cancer Consortium Sioux Falls South Dakota
United States Stanford University Medical Center Stanford California
United States H. Lee Moffitt Cancer Center and Research Institute Tampa Florida
United States Veterans Affairs Medical Center - Tampa (Haley) Tampa Florida
United States CCOP - Toledo Community Hospital Oncology Program Toledo Ohio
United States CCOP - Oklahoma Tulsa Oklahoma
United States CCOP - Carle Cancer Center Urbana Illinois
United States CCOP - MainLine Health Wynnewood Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Eastern Cooperative Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico,  South Africa, 

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