Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yaupon Therapeutics
ClinicalTrials.gov Identifier:
NCT00168064
First received: September 7, 2005
Last updated: October 2, 2012
Last verified: October 2012

September 7, 2005
October 2, 2012
May 2006
August 2010   (final data collection date for primary outcome measure)
Ratio of Response Rates Based on CAILS [ Time Frame: Assessment made at Day 1 and every subsequent visit during treatment ] [ Designated as safety issue: No ]
The ratio of the response rate of the patients treated with the PG formulation to the response rate of the patients treated with the AP formulation. Skin response determined by at least a 50% reduction from baseline in the Composite Assessment of Index Lesion Severity (CAILS) following up to 12 months of treatment
Skin response determined by the Composite Assessment of Index Lesion Severity (CAILS) following up to 12 months of treatment.
Complete list of historical versions of study NCT00168064 on ClinicalTrials.gov Archive Site
  • Severity-weighted Assessment Tool (SWAT) Within up to 12 Months by 2 or More Consecutive Observations Over at Least 4 Weeks [ Time Frame: Assessment made at Day 1 and every subsequent visit during treatment ] [ Designated as safety issue: Yes ]
  • Percent of Participants Achieving at Least 50% Improvement of Severity Weighted Assessment Tool (SWAT) [ Time Frame: Baseline to end of therapy ] [ Designated as safety issue: No ]
    Assessment of lesion distribution and severity. A responder analysis was performed on whether subject achieved at least 50% improvement on scale. This had to be confirmed on at least one visit at least 4 weeks apart.
  • Severity-Weighted Assessment Tool (SWAT) within up to 12 months by 2 or more consecutive observations over at least 4 weeks.
  • Spitzer 5 item General Status Patient Questionnaire
  • Patient Visual Analog scale
  • MF-Specific Patient Questionnaire
Not Provided
Not Provided
 
Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides
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).

The successful use of mechlorethamine (MCH) as a topical agent in the treatment of mycosis fungoides, a form of cutaneous T-cell lymphoma, was first reported in the late 1950s, and provided a rationale for skin-directed chemotherapy that minimized systemic toxicity. Since then, multiple investigators have demonstrated the safety and efficacy of topically applied MCH in the treatment of mycosis fungoides. This study will evaluate the efficacy (non-inferiority), tolerability and safety of topical application of MCH proprietary gel versus a compounded ointment formulation in Aquaphor in patients with stage I or IIA MF.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Mycosis Fungoides
Drug: mechlorethamine-MCH (nitrogen mustard)
All affected areas (lesions) are to be treated once daily for twelve months with mechlorethamine-MCH (nitrogen mustard) 0.02% PG or NM 0.02% AP ointment
Other Names:
  • mechlorethamine
  • nitrogen mustard
  • Active Comparator: 1 (PG - NM (MCH) 0.02%)
    PG - mechlorethamine-MCH (nitrogen mustard) 0.02% gel To evaluate the tolerability and safety of topical mechlorethamine-MCH (nitrogen mustard) 0.02% ointment formulations in patients with stage I or IIA MF
    Intervention: Drug: mechlorethamine-MCH (nitrogen mustard)
  • Active Comparator: 2 (AP - MCH(NM) 0.02%)
    AP - mechlorethamine-MCH (nitrogen mustard) 0.02% compounded in Aquaphor To evaluate the tolerability and safety of mechlorethamine-MCH (nitrogen mustard)0.02% ointment formulations in patients with stage I or IIA MF
    Intervention: Drug: mechlorethamine-MCH (nitrogen mustard)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
260
August 2011
August 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00168064
2005NMMF-201-US
No
Yaupon Therapeutics
Yaupon Therapeutics
Not Provided
Study Director: Stuart Lessin, M.D. Fox Chase Cancer Center
Yaupon Therapeutics
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP