| Phase 1/2 pilot study of methotrexate-laurocapram topical gel for the treatment of patients with early-stage mycosis fungoides. | |
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MedLine Citation:
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PMID: 12756099 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Marie-France Demierre; Luc Vachon; Vincent Ho; Lynda Sutton; Allen Cato; Brian Leyland-Jones |
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Publication Detail:
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Type: Clinical Trial; Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article |
Journal Detail:
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Title: Archives of dermatology Volume: 139 ISSN: 0003-987X ISO Abbreviation: Arch Dermatol Publication Date: 2003 May |
Date Detail:
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Created Date: 2003-05-20 Completed Date: 2003-06-10 Revised Date: 2009-11-03 |
Medline Journal Info:
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Nlm Unique ID: 0372433 Medline TA: Arch Dermatol Country: United States |
Other Details:
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Languages: eng Pagination: 624-8 Citation Subset: AIM; IM |
Affiliation:
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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. mariefrance.demierre@bmc.org |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Topical Adult Aged Azepines / administration & dosage, adverse effects, therapeutic use* Dermatologic Agents / administration & dosage, adverse effects, therapeutic use* Drug Combinations Female Follow-Up Studies Gels Humans Male 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 |
| Chemical | |
Reg. No./Substance:
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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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