 |
|
Phase 1/2 Pilot Study of Methotrexate-Laurocapram Topical Gel for the Treatment of Patients With Early-Stage Mycosis Fungoides
Marie-France Demierre, MD, FRCPC;
Luc Vachon, PhD;
Vincent Ho, MD;
Lynda Sutton, BS;
Allen Cato, MD, PhD;
Brian Leyland-Jones, MD, FRCPC
Arch Dermatol. 2003;139:624-628.
Objectives To assess the safety and tolerability of a topical gel formulation combining methotrexate and laurocapram and to obtain preliminary information on the therapeutic potential of methotrexate-laurocapram in patients with early-stage mycosis fungoides (stage IA or IB).
Design An open-label, phase 1/2 pilot study.
Setting Two academic referral centers.
Patients Ten patients 18 years or older with histologically confirmed stage IA or IB mycosis fungoides.
Intervention The gel formulation of methotrexate-laurocapram was applied to the total body surface, excluding genital, perianal areas, nipples, face, and skin under the breasts, on an every-other-day basis for 24 consecutive weeks.
Main Outcome Measures The safety of methotrexate-laurocapram was assessed in this study by reviewing adverse events and laboratory data. Efficacy outcomes included changes in lesion condition and severity assessments, reduction in area of sample lesions, and the investigator's global evaluation.
Results Adverse events consisted of skin reactions of mild severity. No clinically significant laboratory abnormalities were observed. Based on the investigator's global evaluation at the end of the treatment phase (week 24), 7 (78%) of 9 patients demonstrated a slight-to-moderate response to treatment with methotrexate-laurocapram. Statistical significance (P = .049) was reached for induration and pruritus, a trend (P = .10) was observed for erythema, and no change was found for scaling (P = .37).
Conclusions These findings indicate that the topical administration of methotrexate-laurocapram is safe and in general well tolerated. This treatment may represent a new therapeutic potential for patients with mycosis fungoides.
From the Skin Oncology Program, Boston Medical Center, Boston, Mass (Dr Demierre); Cato Research Canada, St-Laurent, Quebec (Dr Vachon); Skin Care Center, Vancouver, British Columbia (Dr Ho); Durham Pharmaceuticals LLC, Durham, NC (Ms Sutton and Dr Cato); and McGill University, St Mary's Hospital, Montreal, Quebec (Dr Leyland-Jones). The authors have no relevant financial interest in this article.
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
Measuring HRQOL in Patients With Cutaneous T-Cell Lymphoma Undergoing Therapy With Oral Bexarotene and Extracorporeal Photopheresis
Demierre et al.
Arch Dermatol 2007;143:659-661.
FULL TEXT
Health-Related Quality-of-Life Assessment in Patients With Cutaneous T-Cell Lymphoma
Demierre et al.
Arch Dermatol 2005;141:325-330.
ABSTRACT
| FULL TEXT
|
