Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides

Trial ID or NCT#

NCT00168064

Status

not recruiting iconNOT RECRUITING

Purpose

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).

Official Title

A Phase II Pivotal Trial to Evaluate the Safety and Efficacy of Nitrogen Mustard (NM) 0.02% Ointment Formulations in Patients With Stage I or IIA Mycosis Fungoides (MF)

Eligibility Criteria

Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Sunil Arani Reddy
Sunil Arani Reddy
Medical oncologist, Cutaneous oncology specialist
Clinical Associate Professor, Medicine - Oncology
Richard Hoppe
Richard Hoppe
Radiation oncologist
Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology

Contact us to find out if this trial is right for you.

Contact

Natalie Viakhireva
6507238949

View on ClinicalTrials.gov