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Silicon Phthalocyanine Pc4 for Photodynamic Therapy of Cutaneous T-cell Lymphoma: Single and Repeated Photoexposures


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IA Mycosis Fungoides/Sezary Syndrome, Stage IB Mycosis Fungoides/Sezary Syndrome, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IIA Mycosis Fungoides/Sezary Syndrome

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Trial Information

Silicon Phthalocyanine Pc4 for Photodynamic Therapy of Cutaneous T-cell Lymphoma: Single and Repeated Photoexposures


PRIMARY OBJECTIVES:

I. Determine the safety and maximum tolerated dose (MTD) that can be utilized for a single
treatment of Pc 4-PDT (silicon phthalocyanine 4 photo dynamic therapy) on subjects with
mycosis fungoides (MF)/cutaneous T-cell lymphoma (CTCL) stage IA-IIA, by evaluating an
accelerated dose escalation protocol consisting of a single exposure to PDT using
topically-applied Pc 4 and visible light at a wavelength of 675 nm, followed by assessment
of skin biopsies to analyze cellular and molecular changes induced by Pc 4-PDT. (Cohort I)

II. Determine safety and tolerability of repeated light (PDT) exposures after a single
application of Pc 4 to a MF/CTCL plaque, using topically-applied Pc 4 and visible light at a
wavelength of 675nm, followed by assessment of skin biopsies to analyze cellular and
molecular changes induced by Pc 4-PDT. (Cohort II)

III. Identification of targets for assessment of efficacy to assist in planning for a Phase
II study.

OUTLINE: This is a dose-escalation study.

Patients receive silicon phthalocyanine 4 topically and then undergo PDT.

After completion of study treatment, patients are followed up at 24 hours, 1 week, 2 weeks,
and 30 days.


Inclusion Criteria:



- Diagnosed with early stage MF (CTCL stage IA-IIA)

- Has at least 2 evaluable plaques

- Has been off systemic therapies for at least 4 weeks

- Has been off topical therapies for at least 2 weeks

- Has been off phototherapies for at least 2 weeks

- All skin photo-types will be included

- Subjects must have the ability to understand and the willingness to sign a written
informed consent form

- Women of child-bearing potential must agree to utilize a birth control which results
in a failure rate of less that 1% per year during the study; accepted forms of birth
control for this study include: injections such as Depo-Provera and Lunelle, implants
such as Norplant, and intra-uterine devices

- Sexually active males must agree to use a medically acceptable form of birth control
for the duration of the study and for at least 3 months after the last dose of the
study medication; appropriate birth control methods are using a condom with a
spermicide or surgical sterilization

Exclusion Criteria:

- Active history of photosensitivity (e.g. xeroderma pigmentosum, lupus erythematosus,
porphyria, severe polymorphous light eruption, solar urticaria)

- Any medical condition that could be aggravated or may cause extreme discomfort during
the study period

- Lesions only on the face, scalp or other sites that would make biopsies not
cosmetically acceptable

- Women of childbearing potential who are pregnant or attempting to become pregnant are
excluded from this study

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to silicon phthalocyanine (Pc 4) or other agents used in this study

- Patients with uncontrolled intercurrent illness including, but not limited to ongoing
or active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTD defined as the dose immediately below the dose in which 2 or more of 6 patients experience a grade 4 toxicity assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Outcome Time Frame:

Up to 30 days

Safety Issue:

Yes

Principal Investigator

Elma Baron, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CASE2411

NCT ID:

NCT01800838

Start Date:

April 2013

Completion Date:

Related Keywords:

  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
  • Recurrent Mycosis Fungoides/Sezary Syndrome
  • Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
  • Stage IA Mycosis Fungoides/Sezary Syndrome
  • Stage IB Mycosis Fungoides/Sezary Syndrome
  • Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
  • Stage IIA Mycosis Fungoides/Sezary Syndrome
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Mycoses
  • Mycosis Fungoides
  • Sezary Syndrome
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065