An Open Label Six Month Study to Evaluate the Safety and Efficacy of Nitrogen Mustard (NM) 0.04% Ointment Formulation in Patients With Stage I or IIA Mycosis Fungoides (MF) Who Have Completed an Initial 12 Month Treatment With Nitrogen Mustard 0.02% But Without a Complete Response
Information source: Yaupon Therapeutics
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycosis Fungoides
Intervention: Nitrogen mustard (Drug)
Phase: Phase 2
Status: Enrolling by invitation
Sponsored by: Yaupon Therapeutics Official(s) and/or principal investigator(s):
Stuart Lessin, M.D., Principal Investigator, Affiliation: Fox Chase Cancer Center, Philadelphia, PA
Summary
To evaluate the efficacy of topical application of NM 0. 04% in a propylene glycol ointment
(PG)in patients with stage I or IIA MF previously treated with NM 0. 02% in a PG or AP
ointment who did not achieve a complete response.
Clinical Details
Official title: An Open Label Six Month Study to Evaluate the Safety and Efficacy of Nitrogen Mustard (NM) 0.04% Ointment Formulation in Patients With Stage I or IIA Mycosisis Fungoides (MF) Who Have Completed an Initial 12 Month MF Treatment With Nitrogen Mustard 0.02% But Who Have Not Achieved a Complete Response
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Evaluate the efficacy of topical application of NM 0.04% in a propylene glycol ointment (PG) in patients with stage I or IIA MF
Secondary outcome: Evaluate the tolerability and safety of topical application of NM 0..05% ointment formulations in patients with stage I or IIA MF
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 the ongoing clinical trial (2005NMMF-201-US)to either 0. 02% NM PG or 0. 02% NM
in Aquaphor (AP) ointment formulations.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients must have completed the treatment phase of the Yaupon Therapeutics-sponsored
Phase II Pivotal study of NM 0. 02% in either the PG or AP formulation who have not
achieved a complete response.
Locations and Contacts
Stanford University Medical Center, Stanford, California 94305, United States
University of Michigan, A. Alfred Taubman Healthcare Center, Ann Arbor, Michigan 48109-0314, United States
NYU Medical Center Dept. of Dermatology, New York, New York 10016, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111-2497, United States
The University of Texas, M.D. Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information
Starting date: July 2007
Ending date: July 2009
Last updated: December 5, 2007
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