Photodynamic Therapy in Treating Patients With Refractory Mycosis Fungoides

PRIMARY OBJECTIVES:

I. To determine the efficacy of photodynamic therapy (PDT) in refractory tumors and plaques
of mycosis fungoides (MF).

SECONDARY OBJECTIVES:

I. To determine the effects of sequential PDT and radiation therapy (RT). II. To determine
the side effect profile of PDT in MF.

EXPLORATORY OBJECTIVES:

I. To determine the quality of life during and after treatment.

OUTLINE:

Patients receive aminolevulinic acid hydrochloride topically and undergo photodynamic therapy
on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease
progression or unacceptable toxicity. Beginning at week 24, patients undergo radiation
therapy daily for 4 weeks.

After completion of study treatment, patients are followed up for up to 8 weeks.

Inclusion Criteria:

- Histological confirmation of mycosis fungoides as confirmed by the Mayo Clinic Arizona
Dermatopathology Department

- Patients must have a tumor or plaque that is refractory to conventional treatment
including but not limited to one of the following (up to 4 lesions in a single field
of PDT or RT will be considered for treatment):

- Plaque stage disease that has failed at least 2 skin directed therapies
(including topical steroids) or refractory plaques despite at least one systemic
therapy or plaques with evidence of folliculotropism

- The presence of a tumor of MF

- Negative urine pregnancy test done =< 7 days prior to registration, for women of
childbearing potential only

- Ability to complete questionnaire(s) by themselves or with assistance

- Provide written informed consent

- Willing to return to enrolling institution for follow-up (during the Active Monitoring
Phase of the study)

Exclusion Criteria:

- Prior radiation to the same site deemed to be too high of level of radiation for
retreatment

- Photosensitivity disorder, including but not limited to porphyria, or concomitant
photosensitizing drugs that place the patient at an elevated risk of developing severe
side effects to PDT or RT

- Skin cancer other than actinic keratosis, basal cell carcinoma, and squamous cell
carcinoma in situ in the field of RT

- Active infection at the site to be irradiated

- Any underlying condition which prevents the patient from being able to undergo the
required number of sessions of PDT or RT and required follow up

- Pregnancy

- Lactation and a radiation field which would include the breast or nipple or deemed to
place the mother or child at elevated risk of radiation exposure (evaluated by MRP,
ARM, WR, WW)

- An allergy to a component of Levulan

- Women of childbearing potential (post-menopausal or not of child-bearing potential) is
defined by: 1 year of natural (spontaneous) amenorrhea or surgical bilateral
oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at
least 6 weeks ago; oophorectomy alone must confirmed by follow up hormone level
assessment to be considered not of child-bearing potential, defined as all women
physiologically capable of becoming pregnant, unless they are using basic methods of
contraception which includes:

- Total abstinence (Periodic abstinence and withdrawal are not acceptable methods
of contraception)

- Female sterilization (bilateral oophorectomy with or without hysterectomy), total
hysterectomy, or tubal ligation at least 6 weeks before taking study treatment;
oophorectomy alone requires follow up hormone level assessment for fertility

- Male sterilization (at least 6 months prior to screening); the vasectomized male
partner should be the sole partner for that subject

- Barrier methods of contraception: condom or occlusive cap

- Use of oral, injected or implanted hormonal methods of contraception or other
forms or hormonal contraception that have complete efficacy (failure < 1%); (the
dose of the contraceptive should be stable for 3 months)

- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
of the investigator, would make the patient inappropriate for entry into this study or
interfere significantly with the proper assessment of safety and toxicity of the
prescribed regimens

- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV)
positive and currently receiving antiretroviral therapy; NOTE: Patients known to be
HIV positive, but without clinical evidence of an immunocompromised state, are
eligible for this trial

- Uncontrolled inter-current 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