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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)

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).

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : mechlorethamine-MCH (nitrogen mustard)

Phase: Phase 2

Eligibility

Ages Eligible For Study:

N/A - N/A

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

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Contact information

Primary Contact:

Natalie Viakhireva 6507238949

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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