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Home > "M" Clinical Trials Conditions > Methylphenidate in Treating Patients With Melanoma  Methylphenidate in Treating Patients With Melanoma
Methylphenidate in Treating Patients With Melanoma
For Condition: Quality of Life,Fatigue,unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulHutson, Study Chair, Eastern Cooperative Oncology Group
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
MBCCOP-Our Lady of Mercy Cancer Center
Bronx, New York, 10466
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095
United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, 80209-5031
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
MBCCOP - San Juan
San Juan, , 00927-5800
Puerto Rico
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, 33612
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, 37212
United States
Pretoria Academic Hospitals
Pretoria, , 0001
South Africa
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
Veterans Affairs Medical Center - New York
New York City, New York, 10010
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Veterans Affairs Medical Center - Gainsville
Gainesville, Florida, 32608-1197
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
New England Medical Center Hospital
Boston, Massachusetts, 02111
United States
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, 15240
United States
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, 94304
United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, 11209
United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
United States
Additional Information:
Study ID Numbers: CDR0000066161; E-2Z96,NCI-P98-0130
Study Start Date: June 1999
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003266
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer
2. Monoclonal Antibody Therapy in Treating Patients With Advanced Solid Tumors
3. Paclitaxel in Treating Older Patients With Solid Tumors
4. Flavopiridol, Oxaliplatin, Fluorouracil, and Leucovorin in Treating Patients With Advanced Solid Tumors
5. Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Wisconsin Clinical Trials
Other Milwaukee Clinical Trials
Methylphenidate in Treating Patients With Melanoma
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