NCT00168064

Brief Summary

This study will evaluate the efficacy, tolerability and safety of the topical application of mechlorethamine (MCH) formulations in patients with stage I or IIA mycosis fungoides (MF).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2006

Longer than P75 for phase_2

Geographic Reach
1 country

12 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

First Submitted

Initial submission to the registry

September 7, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 31, 2012

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

4.3 years

First QC Date

September 7, 2005

Results QC Date

July 12, 2011

Last Update Submit

October 2, 2012

Conditions

Mycosis Fungoides

Keywords

Mycosis FungoidesNitrogen MustardCutaneous T-Cell LymphomaCTCL - Mycosis Fungoides

Outcome Measures

Primary Outcomes (1)

  • Ratio of Response Rates Based on CAILS

    The ratio of the response rate of the patients treated with the PG formulation to the response rate of the patients treated with the AP formulation. Skin response determined by at least a 50% reduction from baseline in the Composite Assessment of Index Lesion Severity (CAILS) following up to 12 months of treatment

    Assessment made at Day 1 and every subsequent visit during treatment

Secondary Outcomes (2)

  • Severity-weighted Assessment Tool (SWAT) Within up to 12 Months by 2 or More Consecutive Observations Over at Least 4 Weeks

    Assessment made at Day 1 and every subsequent visit during treatment

  • Percent of Participants Achieving at Least 50% Improvement of Severity Weighted Assessment Tool (SWAT)

    Baseline to end of therapy

Study Arms (2)

1 (PG - NM (MCH) 0.02%)

ACTIVE COMPARATOR

PG - mechlorethamine-MCH (nitrogen mustard) 0.02% gel To evaluate the tolerability and safety of topical mechlorethamine-MCH (nitrogen mustard) 0.02% ointment formulations in patients with stage I or IIA MF

Drug: mechlorethamine-MCH (nitrogen mustard)

2 (AP - MCH(NM) 0.02%)

ACTIVE COMPARATOR

AP - mechlorethamine-MCH (nitrogen mustard) 0.02% compounded in Aquaphor To evaluate the tolerability and safety of mechlorethamine-MCH (nitrogen mustard)0.02% ointment formulations in patients with stage I or IIA MF

Drug: mechlorethamine-MCH (nitrogen mustard)

Interventions

mechlorethamine-MCH (nitrogen mustard)DRUG

All affected areas (lesions) are to be treated once daily for twelve months with mechlorethamine-MCH (nitrogen mustard) 0.02% PG or NM 0.02% AP ointment

Also known as: mechlorethamine, nitrogen mustard
1 (PG - NM (MCH) 0.02%)2 (AP - MCH(NM) 0.02%)

Eligibility Criteria

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

You may qualify if:

  • Patients with mycosis fungoides confirmed by a skin biopsy
  • Stage I or IIA patients must have been treated previously with prior topical therapies including PUVA, UVB, topical steroids, but not NM within the past 2 years, or topical carmustine (BCNU)
  • Patients must be otherwise healthy with acceptable organ function.
  • Prior to initiating study therapy, patients must not have had topical therapy within four weeks
  • Lab values within normal range
  • Willing/able to give consent
  • Must use effective means of contraception if of childbearing potential

You may not qualify if:

  • Newly diagnosed mycosis fungoides with no prior therapy
  • A prior history of treatment with topical NM within the past 2 years or topical carmustine (BCNU)
  • Use of topical or systemic therapies for MF within four (4) weeks of entry in the study
  • Patients with a diagnosis of stage IIB-IV MF
  • Serious known concurrent medical illness or infection, which could potentially present a safety risk and/or prevent compliance with the requirements of the treatment program
  • Pregnant or nursing females, or males and females of childbearing potential, not using an effective means of contraception
  • Patients who have had radiation therapy within one year of study start
  • Patients who have a history of a higher T score than T2 or a higher N score than N1
  • Patients who do not agree to do all labs at one site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Northwestern University - Dept. of Dermatology

Chicago, Illinois, 61611, United States

Location

NYU Medical Center Dept. of Dermatology

New York, New York, 10016, United States

Location

Columbia University, Dept. of Dermatology

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Oklahoma University

Tulsa, Oklahoma, 74104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, 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 (7)

  • Kim YH, Martinez G, Varghese A, Hoppe RT. Topical nitrogen mustard in the management of mycosis fungoides: update of the Stanford experience. Arch Dermatol. 2003 Feb;139(2):165-73. doi: 10.1001/archderm.139.2.165.

    PMID: 12588222BACKGROUND

  • Kim YH. Management with topical nitrogen mustard in mycosis fungoides. Dermatol Ther. 2003;16(4):288-98. doi: 10.1111/j.1396-0296.2003.01640.x.

    PMID: 14686971BACKGROUND

  • Kim YH, Jensen RA, Watanabe GL, Varghese A, Hoppe RT. Clinical stage IA (limited patch and plaque) mycosis fungoides. A long-term outcome analysis. Arch Dermatol. 1996 Nov;132(11):1309-13.

    PMID: 8915308BACKGROUND

  • Geskin LJ, Angello JT, Bagot M, Guenova E, Nikbakht N, Querfeld C, Scarisbrick JJ. Evaluating Response Trends of Chlormethine/Mechlorethamine Gel in Patients With Stage I-IIA Mycosis Fungoides: Analysis of Individual Patient Data From a Randomized Controlled Phase II Study to Facilitate Optimal Treatment Experiences. Clin Lymphoma Myeloma Leuk. 2024 Jan;24(1):40-47. doi: 10.1016/j.clml.2023.08.020. Epub 2023 Sep 7.

    PMID: 37802679DERIVED

  • 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

  • Querfeld C, Scarisbrick JJ, Assaf C, Guenova E, Bagot M, Ortiz-Romero PL, Quaglino P, Bonizzoni E, Hodak E. Post hoc Analysis of a Randomized, Controlled, Phase 2 Study to Assess Response Rates with Chlormethine/Mechlorethamine Gel in Patients with Stage IA-IIA Mycosis Fungoides. Dermatology. 2022;238(2):347-357. doi: 10.1159/000516138. Epub 2021 Jun 4.

    PMID: 34091453DERIVED

  • Lessin SR, Duvic M, Guitart J, Pandya AG, Strober BE, Olsen EA, Hull CM, Knobler EH, Rook AH, Kim EJ, Naylor MF, Adelson DM, Kimball AB, Wood GS, Sundram U, Wu H, Kim YH. Topical chemotherapy in cutaneous T-cell lymphoma: positive results of a randomized, controlled, multicenter trial testing the efficacy and safety of a novel mechlorethamine, 0.02%, gel in mycosis fungoides. JAMA Dermatol. 2013 Jan;149(1):25-32. doi: 10.1001/2013.jamadermatol.541.

    PMID: 23069814DERIVED

MeSH Terms

Conditions

Mycosis FungoidesLymphoma, T-Cell, Cutaneous

Interventions

Mechlorethamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
H. Jeffrey Wilkins, MD
Organization
Yaupon Therapeutics
hjwilkins@yaupontherapeutics.com
4843247935

Study Officials

  • Stuart Lessin, M.D.

    Fox Chase Cancer Center

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 14, 2005

Study Start

May 1, 2006

Primary Completion

August 1, 2010

Study Completion

August 1, 2011

Last Updated

October 31, 2012

Results First Posted

October 31, 2012

Record last verified: 2012-10

Locations

US(12)