Trial Information

Summary: A phase II trial to evaluate the safety and effectiveness of nitrogen mustard (NM) 0.02% ointment formulations in patients with stage I or IIA mycosis fungoides (MF)

MF is a form of cutaneous T-cell lymphoma and is typically a chronic, slowly progressive disease of 10 to 20 years duration classified into four clinical stages. Nitrogen mustard is an investigational ointment that has not been approved by the Food and Drug Administration (FDA) to treat MF. The purpose of this research study is to compare the effectiveness of two ointment formulations of nitrogen mustard (NM), a chemotherapy agent, in treating MF. Nitrogen mustard has been one of the treatments used in the standard of care for mycosis fungoides for 50 years but has never been approved for use by the Food and Drug Administration (FDA). This is, in part, because no formal clinical trial has been performed to evaluate and document its effects on patients and their disease.

Subjects will visit the clinic for a screening visit followed by an initial visit to receive study ointment. Once subjects receive their study ointment they will return to the clinic once a month for up to 6 months and then once every two months for the remaining 6 months. Subjects will be in this research study for a full 12 months during which time they will be treating their skin with NM ointment. After they have completed 12 months of treatment, subjects will be followed for up to an additional twelve months to monitor for any side effects. Blood specimens and photography will be performed at certain visits throughout the trial.

Subjects will be compensated if they participate in this study.

Inclusion criteria for this study includes the following:

• Laboratory values within the range of normal for the participating institution unless the principal investigator feels they are not clinically relevant.
• Must be free of serious concurrent illness.
• Must be willing and able to give informed consent, comply with study instructions and commit to all study visits and procedures.
• Males and females of childbearing potential should be using an effective means of contraception.

Exclusion criteria includes the following:

• Newly diagnosed MF with no prior therapy.
• A prior history of treatment with topical NM 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
• Patients who have a history of a higher T score of T2 or a higher N score of N1.
• Patients who have had radiation therapy within one year of study start..
• Any patient who does not agree to do all lab studies at one site.
• Pregnant or nursing females, or males and females of childbearing potential, not using an effective means of contraception
• 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.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.