Silicon Phthalocyanine 4 and Photodynamic Therapy in Stage IA-IIA Cutaneous T-Cell Non-Hodgkin Lymphoma
Condition: 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
MeSH terms: Mycoses; Lymphoma; Lymphoma, Non-Hodgkin; Mycosis Fungoides; Sezary Syndrome; Lymphoma, T-Cell; Lymphoma, T-Cell, Cutaneous; Syndrome; Recurrence
Intervention: silicon phthalocyanine 4; photodynamic therapy; pharmacological study; laboratory biomarker analysis
Intervention description: Given topically; Undergo PDT; Correlative studies; Correlative studies
Intervention MeSH terms: Silicon; Silicon phthalocyanine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase I trial studies the side effects and best dose of silicon phthalocyanine 4 and
      photodynamic therapy in treating patients with stage IA-IIA cutaneous T-cell non-Hodgkin
      lymphoma. Photodynamic therapy (PDT) uses a drug, silicon phthalocyanine 4, that becomes
      active when it is exposed to a certain kind of light. When the drug is active, cancer cells
      are killed. This may be effective against cutaneous T-cell non-Hodgkin lymphoma.

      Funding Source - FDA OOPD
    

Eligibility criteria:

        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