Document Detail

Phase 1/2 pilot study of methotrexate-laurocapram topical gel for the treatment of patients with early-stage mycosis fungoides.
MedLine Citation:
PMID:  12756099     Owner:  NLM     Status:  MEDLINE    
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.
Marie-France Demierre; Luc Vachon; Vincent Ho; Lynda Sutton; Allen Cato; Brian Leyland-Jones
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article    
Journal Detail:
Title:  Archives of dermatology     Volume:  139     ISSN:  0003-987X     ISO Abbreviation:  Arch Dermatol     Publication Date:  2003 May 
Date Detail:
Created Date:  2003-05-20     Completed Date:  2003-06-10     Revised Date:  2009-11-03    
Medline Journal Info:
Nlm Unique ID:  0372433     Medline TA:  Arch Dermatol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  624-8     Citation Subset:  AIM; IM    
Skin Oncology Program, Department of Dermatology, Boston Medical Center, Boston University School of Medicine, 720 Harrison Avenue, Doctors Office Building 801A, Boston, MA 02118, USA.
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MeSH Terms
Administration, Topical
Azepines / administration & dosage,  adverse effects,  therapeutic use*
Dermatologic Agents / administration & dosage,  adverse effects,  therapeutic use*
Drug Combinations
Follow-Up Studies
Methotrexate / administration & dosage,  adverse effects,  therapeutic use*
Middle Aged
Mycosis Fungoides / drug therapy*,  pathology
Neoplasm Staging
Pilot Projects
Skin Neoplasms / drug therapy*,  pathology
Time Factors
Treatment Outcome
Reg. No./Substance:
0/Azepines; 0/Dermatologic Agents; 0/Drug Combinations; 0/Gels; 59-05-2/Methotrexate; 59227-89-3/laurocapram

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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