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

Information source: Yaupon Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mycosis Fungoides

Intervention: 0.04% Mechlorethamine gel (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Yaupon Therapeutics

Official(s) and/or principal investigator(s):
Stuart Lessin, M.D., Principal Investigator, Affiliation: Fox Chase Cancer Center

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.

Clinical Details

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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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 0.04% 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 clinical trial (2005NMMF-201-US)to either 0. 02% MCH PG or 0. 02% MCH 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 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

Locations and Contacts

Stanford University Medical Center, Stanford, California 94305, United States

Northwestern University-Dept. of Dermatology, Chicago, Illinois 61611, United States

Columbia University, Dept of Dermatology, New York, New York 10016, 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

Oklahoma University, Tulsa, Oklahoma 74104, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111-2497, United States

University of Texas, Southwestern Medical Center, Dallas, Texas 75390, United States

The University of Texas, M.D. Anderson Cancer Center, Houston, Texas 77030, United States

Utah Clinical Trials, LLC, Salt Lake City, Utah 84107, United States

University of Wisconsin, Madison, Wisconsin 53791, United States

Additional Information

Starting date: July 2007
Last updated: August 7, 2012

Page last updated: August 23, 2015

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