Phase 2
N=260
Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides
Mycosis Fungoides
Bottom Line
View on ClinicalTrials.gov: NCT00168064 ↗Enrolled (actual)
260
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Ratio of Response Rates Based on CAILS — 76; 62 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- mechlorethamine-MCH (nitrogen mustard) (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Yaupon Therapeutics
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio of Response Rates Based on CAILS |
76; 62 | — |
| SECONDARY Severity-weighted Assessment Tool (SWAT) Within up to 12 Months by 2 or More Consecutive Observations Over at Least 4 Weeks |
— | — |
| SECONDARY Percent of Participants Achieving at Least 50% Improvement of Severity Weighted Assessment Tool (SWAT) |
61; 60 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00168064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.