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Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides
Not Recruiting
Trial ID: NCT00168064
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)
Stanford Investigator(s)
Richard Hoppe
Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology
Sunil Arani Reddy
Clinical Associate Professor, Medicine - Oncology
Eligibility
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
Intervention(s):
drug: mechlorethamine-MCH (nitrogen mustard)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Natalie Viakhireva
6507238949