Purpose

To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Subjects must have a clinical diagnosis of CTCL (mycosis fungoides), Stage IA, Stage IB, or Stage IIA.
  • Subjects must have a minimum of three (3) evaluable, discrete lesions.
  • Subjects must be willing to refrain from sunbathing for the duration of the study.

Exclusion Criteria

  • History of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, Sj√∂gren's syndrome, xeroderma pigmentosum, polymorphous light eruptions or radiation therapy within 30 days of enrolling.
  • Pregnancy or mothers who are breast feeding.
  • Males and females not willing to use effective contraception.
  • Unhealed sunburn.
  • Subjects receiving topical steroids or other topical treatments for CTCL within 2 weeks.
  • Subjects receiving systemic steroids, nitrogen mustard, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment.
  • Subjects with significant history of systemic immunosuppression due to drugs or infection with HIV or HTLV 1.
  • Subjects taking other investigational drugs or drugs of abuse within 30 days of entry into this study.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
SGX301
Three treatment cycles, each six (6) weeks followed by a two (2) week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy. Cycle 1: Patients randomized 2:1 to active/placebo will have three (3) index lesions treated and evaluated. Cycle 2: All patients will have three (3) index lesions treated and evaluated with active SGX301 ointment. Cycle 3: All patients will be given the opportunity to enter an open-label cycle of active SGX301 ointment treatment for all lesions (index and non-index).
  • Drug: SGX301 (synthetic hypericin)
    0.25% SGX301 in USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light.
    Other names:
    • Hypericin
    • Synthetic Hypericin
Placebo Comparator
Placebo
Placebo ointment is indistinguishable from ointment containing active SGX301 and is only used in Cycle 1. Treatment paradigm (ointment application and fluorescent light therapy) is identical.
  • Drug: Placebo
    USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light.

Recruiting Locations

University of Alabama Birmingham
Birmingham, Alabama 35294
Contact:
Rhonda Kaler
dermresearch@uabmc.edu

University of Arizona
Phoenix, Arizona 85004
Contact:
Michele Aguirre
maguirre@usdermpartners.com

Mayo Clinic
Scottsdale, Arizona 85259
Contact:
Jacqueline Smith
smith.jacqueline1@mayo.edu

University of Arkansas
Little Rock, Arkansas 72205
Contact:
James Douglas
JDouglas@uams.edu

Stanford University
Palo Alto, California 94304
Contact:
Sydney Yee
sydneyy@stanford.edu

Therapeutics Clinical Research
San Diego, California 92123
Contact:
Araceli Torres
atorres@therapeuticsresearch.com

Olympian Clinical Research
Clearwater, Florida 33756
Contact:
Dustin Siegert
dsiegert@olympianresearch.com

Leon Medical Research
Miami, Florida 33015
Contact:
Ivette Piloto
ipiloto@leonmedicalresearch.com

Medical Professional Clinical Research
Miami, Florida 33165
Contact:
Priscilla Torrado-Hernandez
ptorrado@mpcresearch.com

University of South Florida
Tampa, Florida 33612
Contact:
Janet Wilson
jlwilso6@health.usf.edu

Northwestern University
Chicago, Illinois 60611
Contact:
Katherine Bagnowski
katherine.lewandowski@northwestern.edu

Rush University
Chicago, Illinois 60612
Contact:
Danica Uzelac
Danica_Uzelac@rush.edu

Dawes Fretzin Dermatology Group
Indianapolis, Indiana 46256
Contact:
Laura Murphy
LSuchy@ecommunity.com

Tulane University
New Orleans, Louisiana 70112
Contact:
Edward Coleman
ecoleman@tulane.edu

University of Maryland
Baltimore, Maryland 21201
Contact:
Nicole Glynn
nglynn@umm.edu

University of Minnesota
Minneapolis, Minnesota 55455
Contact:
Irmina Wallander
wall0396@umn.edu

Washington University
Saint Louis, Missouri 63110
Contact:
Mary Tabacchi
mtabacch@dom.wustl.edu

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
Contact:
Debra Rodgers
debra.j.rodgers@hitchcock.org

Rochester Skin Lymphoma Medical Group
Fairport, New York 14450
Contact:
Brian Poligone
bpoligone@roclymphoma.com

Columbia University Medical Center
New York, New York 10032
Contact:
Megan Trager
mht2132@cumc.columbia.edu

Stony Brook Medicine
Stony Brook, New York 11790
Contact:
Jennifer Intravaia
Jennifer.Intravaia@stonybrookmedicine.edu

PMG Research of Wilmington
Wilmington, North Carolina 28401
Contact:
Erica Hager
erica.hager@pmg-research.com

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
Contact:
Christina Bona
Christina.Bona2@UHhospitals.org

Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
Contact:
Deborah Leahy
Deborah.Leahy@uphs.upenn.edu

Jefferson Dermatology
Philadelphia, Pennsylvania 19107
Contact:
Nish Vadalia
Nish.Vadalia@jefferson.edu

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
Contact:
Sue A. McCann
mccannsa@upmc.edu

Medical University of South Carolina
Charleston, South Carolina 29424
Contact:
Ormarie Vazquez Silva
vazquezo@musc.edu

Vanderbilt University
Nashville, Tennessee 37212
Contact:
Nikki Bratcher
nikki.bratcher@vumc.org

MD Anderson
Houston, Texas 77030
Contact:
Carol Wilson
clwilson@mdanderson.org

Austin Institute for Clinical Research
Pflugerville, Texas 78660
Contact:
Amanda Beatty
amanda@atxresearch.com

INOVA Schar Cancer Institute
Fairfax, Virginia 22031
Contact:
Kelly Jeffords
Kelly.Jeffords@inova.org

Virginia Clinical Research
Norfolk, Virginia 23502
Contact:
Erin Rivera
erivera@vcrinc.org

Seattle Care Cancer Center
Seattle, Washington 98109
Contact:
Genevieve Alcorn
galcorn@seattlecca.org

More Details

NCT ID
NCT02448381
Status
Recruiting
Sponsor
Soligenix

Study Contact

Christopher Pullion, DO
609-538-8200
cpullion@soligenix.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.