Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056056
Status:
TERMINATED
Last Update Posted:
2018-07-09
First Post:
2003-03-06
Brief Title:
Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Randomized Open-Label Phase III Trial to Evaluate the Efficacy and Safety of Bexarotene Targretin Capsules Combined With PUVA Compared to PUVA Treatment Alone in Patients With Mycosis Fungoides
Status:
TERMINATED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Ultraviolet light therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells It is not yet known whether ultraviolet light therapy is more effective with or without bexarotene in treating mycosis fungoides
PURPOSE Randomized phase III trial to compare the effectiveness of ultraviolet light therapy using methoxsalen with or without bexarotene in treating patients who have mycosis fungoides
PURPOSE Randomized phase III trial to compare the effectiveness of ultraviolet light therapy using methoxsalen with or without bexarotene in treating patients who have mycosis fungoides
Detailed Description:
OBJECTIVES
Determine if ultraviolet A light therapy with methoxsalen PUVA with or without bexarotene yields a significantly higher overall response rate in patients with mycosis fungoides
Compare the overall response rate CCR and partial response in patients treated with these regimens
Compare the duration of CCR and time to relapse of patients treated with these regimens
Compare the number of PUVA sessions necessary to achieve a CCR in these patients
Determine the percentage of dropouts by patients treated with these regimens
Determine the safety of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to participating center age 60 and under vs over 60 and stage of disease IB vs IIA Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive PUVA comprising oral methoxsalen given 2 hours before whole body ultraviolet A therapy PUVA is given 3 times per week
Arm II Patients receive oral bexarotene once daily and PUVA as in arm I In both arms treatment repeats for up to 16 weeks in the absence of complete clinical response disease progression or unacceptable toxicity
Patients are followed every 8 weeks until the first documented progression or relapse
PROJECTED ACCRUAL A total of 145 patients will be accrued for this study within 25 months
Determine if ultraviolet A light therapy with methoxsalen PUVA with or without bexarotene yields a significantly higher overall response rate in patients with mycosis fungoides
Compare the overall response rate CCR and partial response in patients treated with these regimens
Compare the duration of CCR and time to relapse of patients treated with these regimens
Compare the number of PUVA sessions necessary to achieve a CCR in these patients
Determine the percentage of dropouts by patients treated with these regimens
Determine the safety of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to participating center age 60 and under vs over 60 and stage of disease IB vs IIA Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive PUVA comprising oral methoxsalen given 2 hours before whole body ultraviolet A therapy PUVA is given 3 times per week
Arm II Patients receive oral bexarotene once daily and PUVA as in arm I In both arms treatment repeats for up to 16 weeks in the absence of complete clinical response disease progression or unacceptable toxicity
Patients are followed every 8 weeks until the first documented progression or relapse
PROJECTED ACCRUAL A total of 145 patients will be accrued for this study within 25 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 |
|---|---|---|---|
| 2004-003701-24 | EUDRACT_NUMBER | None | None |