Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy, tolerability and safety of the topical application of mechlorethamine (MCH) formulations in patients with stage I or IIA mycosis fungoides (MF).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yaupon Therapeutics
• Treatments: Mechlorethamine; Nitrogen Mustard Compounds

Criteria

Inclusion Criteria:

• Patients with mycosis fungoides confirmed by a skin biopsy

• Stage I or IIA patients must have been treated previously with prior topical therapies including PUVA, UVB, topical steroids, but not NM within the past 2 years, or topical carmustine (BCNU)

• Patients must be otherwise healthy with acceptable organ function.

• Prior to initiating study therapy, patients must not have had topical therapy within four weeks

• Lab values within normal range

• Willing/able to give consent

• Must use effective means of contraception if of childbearing potential

Exclusion Criteria:

• Newly diagnosed mycosis fungoides with no prior therapy

• A prior history of treatment with topical NM within the past 2 years or topical carmustine (BCNU)

• Use of topical or systemic therapies for MF within four (4) weeks of entry in the study

• Patients with a diagnosis of stage IIB-IV MF

• Serious known concurrent medical illness or infection, which could potentially present a safety risk and/or prevent compliance with the requirements of the treatment program

• Pregnant or nursing females, or males and females of childbearing potential, not using an effective means of contraception

• Patients who have had radiation therapy within one year of study start

• Patients who have a history of a higher T score than T2 or a higher N score than N1

• Patients who do not agree to do all labs at one site