Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030589
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2002-02-14
Brief Title:
Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma
Sponsor:
Millennix
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Muliticenter Dose-Reandomized Evaluation Of Targretin Capsules Plus PUVA In Patients With Stage IB - IIA Cutaneous T-Cell Lymphoma
Status:
UNKNOWN
Status Verified Date:
2003-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill cancer cells Photosensitizing drugs such as methoxsalen are absorbed by cancer cells and when exposed to light become active and kill the cancer cells Combining chemotherapy with photodynamic therapy may be an effective treatment for cutaneous T-cell lymphoma
PURPOSE Randomized phase II trial to study the effectiveness of combining different doses of bexarotene with photodynamic therapy in treating patients who have stage IB or stage IIA cutaneous T-cell lymphoma
PURPOSE Randomized phase II trial to study the effectiveness of combining different doses of bexarotene with photodynamic therapy in treating patients who have stage IB or stage IIA cutaneous T-cell lymphoma
Detailed Description:
OBJECTIVES
Compare the efficacy of 2 different doses of bexarotene administered with ultraviolet A light therapy with methoxsalen PUVA in patients with stage IB or IIA cutaneous T-cell lymphoma
Compare the safety of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive a lower dose of oral bexarotene once daily on weeks 1-26 Patients also receive ultraviolet A light therapy with oral methoxsalen 3 times weekly on weeks 2-26
Arm II Patients receive a higher dose of oral bexarotene once daily on weeks 1-26 Patients also receive ultraviolet A light therapy as in arm I
Patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm will be accrued for this study
Compare the efficacy of 2 different doses of bexarotene administered with ultraviolet A light therapy with methoxsalen PUVA in patients with stage IB or IIA cutaneous T-cell lymphoma
Compare the safety of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive a lower dose of oral bexarotene once daily on weeks 1-26 Patients also receive ultraviolet A light therapy with oral methoxsalen 3 times weekly on weeks 2-26
Arm II Patients receive a higher dose of oral bexarotene once daily on weeks 1-26 Patients also receive ultraviolet A light therapy as in arm I
Patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NU-IRB-837-002 | None | None | None |
| MILL-61896 | None | None | None |
| LIGAND-MILL-61896 | None | None | None |