Overview

Methylphenidate in Treating Patients With Melanoma

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eastern Cooperative Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Methylphenidate
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