Clinical trial NCT00535470: An Open Label Study to Evaluate the Safety and Efficacy of Mechlorethamine(MCH) 0.04% Formulation in Mycosis Fungoides
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mycosis Fungoides
Lead sponsor: Yaupon Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 7 months
Secondary outcomes:
measure: Evaluate the tolerability and safety of topical application of NM 0.04% ointment formulations in patients with stage I or IIA MF
timeFrame: 7 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Chicago
country: United States
facility: Northwestern University-Dept. of Dermatology
state: Illinois
city: New York
country: United States
facility: Columbia University, Dept of Dermatology
state: New York
city: New York
country: United States
facility: NYU Medical Center Dept. of Dermatology
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Tulsa
country: United States
facility: Oklahoma University
state: Oklahoma
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas, Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas, M.D. Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Utah Clinical Trials, LLC
state: Utah
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Fox Chase Cancer Center
name: Stuart Lessin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Querfeld C, Scarisbrick JJ, Assaf C, Kim YH, Guitart J, Quaglino P, Hodak E. Chlormethine Gel Versus Chlormethine Ointment for Treatment of Patients with Mycosis Fungoides: A Post-Hoc Analysis of Clinical Trial Data. Am J Clin Dermatol. 2022 Jul;23(4):561-570. doi: 10.1007/s40257-022-00687-y. Epub 2022 May 10.