NCT00535470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2007

Typical duration for phase_2

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

August 9, 2012

Status Verified

August 1, 2012

Enrollment Period

3.7 years

First QC Date

September 24, 2007

Last Update Submit

August 7, 2012

Conditions

Mycosis Fungoides

Outcome Measures

Primary Outcomes (1)

  • Evaluate the efficacy of topical application of NM 0.04% in a propylene glycol ointment (PG) in patients with stage I or IIA MF

    7 months

Secondary Outcomes (1)

  • Evaluate the tolerability and safety of topical application of NM 0.04% ointment formulations in patients with stage I or IIA MF

    7 months

Study Arms (1)

1

EXPERIMENTAL

Open label 0.04% Mechlorethamine gel

Drug: 0.04% Mechlorethamine gel

Interventions

0.04% Mechlorethamine gelDRUG

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.

Also known as: Nitrogen Mustard 0.04%
1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant or nursing females, or males and females of childbearing potential, not using an effective means of contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Northwestern University-Dept. of Dermatology

Chicago, Illinois, 61611, United States

Location

Columbia University, Dept of Dermatology

New York, New York, 10016, United States

Location

NYU Medical Center Dept. of Dermatology

New York, New York, 10016, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Oklahoma University

Tulsa, Oklahoma, 74104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

University of Texas, Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

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

Houston, Texas, 77030, United States

Location

Utah Clinical Trials, LLC

Salt Lake City, Utah, 84107, United States

Location

University of Wisconsin

Madison, Wisconsin, 53791, United States

Location

Related Publications (1)

  • 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.

    PMID: 35536441DERIVED

MeSH Terms

Conditions

Mycosis Fungoides

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, CutaneousLymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Stuart Lessin, M.D.

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2007

First Posted

September 26, 2007

Study Start

July 1, 2007

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

August 9, 2012

Record last verified: 2012-08

Locations

US(11)