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

This study is enrolling participants by invitation only.

First Received: September 24, 2007 Last Updated: October 1, 2008 History of Changes

Sponsored by:	Yaupon Therapeutics
Information provided by:	Yaupon Therapeutics
ClinicalTrials.gov Identifier:	NCT00535470

Purpose

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.

Condition	Intervention	Phase
Mycosis Fungoides	Drug: Nitrogen mustard	Phase II

MedlinePlus related topics: Fungal Infections

Drug Information available for: Mechlorethamine Mechlorethamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Yaupon Therapeutics:

Primary Outcome Measures:

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: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate the tolerability and safety of topical application of NM 0..05% ointment formulations in patients with stage I or IIA MF [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	July 2007
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Multi-center, open-label study of patients with previously treated stage I or IIA MF who have not received complete response after completing 12 months of treatment in the ongoing Yaupon Therapeutics study with PG or AP formulations of 0.02% NM	Drug: Nitrogen mustard NM 0.04% PG applied to affected skin areas (lesions) once daily for up to six (6) months. The frequency of application may be adjusted for toxicity. After six (6) months, they will be terminated from the study.

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535470

Locations

United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Michigan
University of Michigan, A. Alfred Taubman Healthcare Center
Ann Arbor, Michigan, United States, 48109-0314
United States, New York
NYU Medical Center Dept. of Dermatology
New York, New York, United States, 10016
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
United States, Texas
The University of Texas, M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Yaupon Therapeutics

Investigators

Principal Investigator:

Stuart Lessin, M.D.

Fox Chase Cancer Center, Philadelphia, PA

More Information

No publications provided

Responsible Party:	Yaupon Therapeutics, Inc. ( Stuart R. Lessin, M.D., Principal Investigator )
Study ID Numbers:	2007NMMF-202-US
Study First Received:	September 24, 2007
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00535470 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Immunoproliferative Disorders
Sezary Syndrome
Mycosis Fungoides
Mycoses
Lymphatic Diseases
Cutaneous T-cell Lymphoma
Lymphoma, T-Cell
Mechlorethamine

Antineoplastic Agents, Alkylating
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Alkylating Agents
Lymphoma
Nitrogen Mustard Compounds
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Sezary Syndrome
Mycosis Fungoides
Pharmacologic Actions
Mycoses
Lymphatic Diseases
Neoplasms

Therapeutic Uses
Mechlorethamine
Lymphoma, T-Cell
Antineoplastic Agents, Alkylating
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Alkylating Agents
Lymphoma
Nitrogen Mustard Compounds
Lymphoma, T-Cell, Cutaneous

ClinicalTrials.gov processed this record on May 07, 2009