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Methylphenidate in Treating Patients With Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003266
Recruitment Status : Completed
First Posted : October 28, 2003
Last Update Posted : November 2, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Eastern Cooperative Oncology Group

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE October 28, 2003
Last Update Posted Date November 2, 2020
Study Start Date  ICMJE June 1999
Actual Primary Completion Date May 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Methylphenidate in Treating Patients With Melanoma
Official Title  ICMJE Double-Blind Randomized Trial of Methylphenidate for Alleviation of Fatigue and Lethargy Associated With Interferon Alpha 2b
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
Condition  ICMJE
  • Fatigue
  • Unspecified Adult Solid Tumor, Protocol Specific
Intervention  ICMJE
  • Drug: methylphenidate hydrochloride
  • Procedure: quality-of-life assessment
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February¬†8,¬†2007)
200
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003266
Other Study ID Numbers  ICMJE CDR0000066161
E-2Z96
NCI-P98-0130
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eastern Cooperative Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Paul R. Hutson, PharmD University of Wisconsin, Madison
PRS Account Eastern Cooperative Oncology Group
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP