silicon phthalocyanine 4 and photodynamic therapy in stage ia-iia cutaneous t-cell non-hodgkin lymphoma

Conditions: 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

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

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.

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