drugset / Trial / NCT00306969
Study of Oral Bexarotene in Combination With Photopheresis for Treatment of Cutaneous T-Cell Lymphoma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a pilot study of the safety and tolerability of photopheresis in combination with increasing doses of oral bexarotene in patients with cutaneous T-cell lymphoma.Our hypotheses are that the combination of bexarotene with photopheresis is safe and that bexarotene will enhance immune response in the setting of extracorporeal photopheresis in the treatment of cutaneous T-cell lymphoma (CTCL), resulting in a shorter time to clinical response.
Timeline
- Start
- 2001-12
- Primary completion
- —
- Completion
- 2004-04
Publications
- Background Duvic M, Martin AG, Kim Y, Olsen E, Wood GS, Crowley CA, Yocum RC; Worldwide Bexarotene Study Group. Phase 2 and 3 clinical trial of oral bexarotene (Targretin capsules) for the treatment of refractory or persistent early-stage cutaneous T-cell lymphoma. Arch Dermatol. 2001 May;137(5):581-93.
- Background Girardi M, Heald PW, Wilson LD. The pathogenesis of mycosis fungoides. N Engl J Med. 2004 May 6;350(19):1978-88. doi: 10.1056/NEJMra032810. No abstract available.
- Demierre MF, Ferzli P, Miller D. Measuring HRQOL in patients with cutaneous T-cell lymphoma undergoing therapy with oral bexarotene and extracorporeal photopheresis. Arch Dermatol. 2007 May;143(5):659-61. doi: 10.1001/archderm.143.5.659. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bexarotene | Small molecule | 75 mg | Oral |
| Subject | Bexarotene | Small molecule | 150 mg | Oral |
| Subject | Bexarotene | Small molecule | 225 mg | Oral |
| Subject | Bexarotene | Small molecule | 300 mg | Oral |
| Subject | Bexarotene | Small molecule | 375 mg | Oral |
| Subject | Bexarotene | Small molecule | 450 mg | Oral |