Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003266
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
1999-11-01
Brief Title:
Methylphenidate in Treating Patients With Melanoma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Double-Blind Randomized Trial of Methylphenidate for Alleviation of Fatigue and Lethargy Associated With Interferon Alpha 2b
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P98-0130 | None | None | None |
| E-2Z96 | None | None | None |