An Open Label Study to Evaluate the Safety and Efficacy of Mechlorethamine(MCH) 0.04% Formulation in Mycosis Fungoides

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yaupon Therapeutics
ClinicalTrials.gov Identifier:
NCT00535470
First received: September 24, 2007
Last updated: August 7, 2012
Last verified: August 2012

September 24, 2007
August 7, 2012
July 2007
March 2011   (final data collection date for primary outcome measure)
Evaluate the efficacy of topical application of NM 0.04% in a propylene glycol ointment (PG) in patients with stage I or IIA MF [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00535470 on ClinicalTrials.gov Archive Site
Evaluate the tolerability and safety of topical application of NM 0.04% ointment formulations in patients with stage I or IIA MF [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
An Open Label Study to Evaluate the Safety and Efficacy of Mechlorethamine(MCH) 0.04% Formulation in Mycosis Fungoides
An Open Label Study to Evaluate the Safety and Efficacy of Nitrogen Mustard (Mechlorethamine - MCH) 0.04% Formulation in Patients With Stage I-IIA Mycosis Fungoides Who Have Completed 12 Months Treatment Without a Complete Response

To evaluate the efficacy and safety of topical application of MCH 0.04% in a propylene glycol ointment (PG)in patients with stage I or IIA MF previously treated with MCH 0.02% in a PG or AP ointment who did not achieve a complete response.

This is a multi-center, open-label study of patients with previously treated stage I (IA and IB) or IIA MF who have not received a complete response after completing 12 months of treatment in clinical trial (2005NMMF-201-US)to either 0.02% MCH PG or 0.02% MCH in Aquaphor (AP) ointment formulations.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mycosis Fungoides
Drug: 0.04% Mechlorethamine gel
Mechlorethamine 0.04% PG applied to affected skin areas (lesions) once daily for up to seven (7) months. The frequency of application may be adjusted for toxicity. After seven (7) months, they will be terminated from the study.
Other Name: Nitrogen Mustard 0.04%
Experimental: 1
Open label 0.04% Mechlorethamine gel
Intervention: Drug: 0.04% Mechlorethamine gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have completed the treatment phase of the Yaupon Therapeutics-sponsored Phase II Pivotal study of MCH 0.02% in either the PG or AP formulation and have not achieved a complete response.

Exclusion Criteria:

  • Pregnant or nursing females, or males and females of childbearing potential, not using an effective means of contraception
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00535470
2007NMMF-202-US
No
Yaupon Therapeutics
Yaupon Therapeutics
Not Provided
Principal Investigator: Stuart Lessin, M.D. Fox Chase Cancer Center
Yaupon Therapeutics
August 2012

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