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

NCT ID: NCT00535470

Last Updated: 2012-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Mycosis Fungoides

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Open label 0.04% Mechlorethamine gel

Group Type EXPERIMENTAL

0.04% Mechlorethamine gel

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Nitrogen Mustard 0.04%

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yaupon Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stuart Lessin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Locations

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Stanford University Medical Center

Stanford, California, United States

Site Status

Northwestern University-Dept. of Dermatology

Chicago, Illinois, United States

Site Status

Columbia University, Dept of Dermatology

New York, New York, United States

Site Status

NYU Medical Center Dept. of Dermatology

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Oklahoma University

Tulsa, Oklahoma, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

University of Texas, Southwestern Medical Center

Dallas, Texas, United States

Site Status

The University of Texas, M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Utah Clinical Trials, LLC

Salt Lake City, Utah, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35536441 (View on PubMed)

Other Identifiers

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2007NMMF-202-US

Identifier Type: -

Identifier Source: org_study_id