Methoxsalen in Combination with Photopheresis for the Treatment of Mycosis Fungoides

Inclusion Criteria

• Subjects who are male or female
• Subjects over the age of 18
• Subjects < 40 kg body weight with adequate veins to provide intravenous access
• Subjects who are willing to adhere to the protocol and sign an informed patient consent document
• Subjects must not be on any other investigational device/drug treatment
• Subjects who have the diagnosis of mycosis fungoides (MF) including a skin biopsy consistent with MF (atypical epidermotrophic or folliculocentric T-cells) with appropriate staging as IA, IB or IIA: T1 or T2 (patches or plaques) with measurable lesions
• Subjects with IA stage must demonstrate a minor blood abnormality by morphology/laboratory assessment
• Subjects with IIA stage - clinically significant nodes (1.5 cm) must have lymph node biopsy showing dermatopathic nodes or no involvement
• Subjects must be willing and able to discontinue concomitant medications for MF. Subjects currently taking the following drugs must discontinue medication with the following wash out periods prior to enrollment in the trial: Psoralen plus UVA (PUVA) or ultraviolet B (UVB) therapy – 4 weeks, topical nitrogen mustard or other topical chemotherapy – 4 weeks, bexarotene capsules or other systemic biologic agent – 3 weeks washout, high dose topical steroids, topical retinoids or immunotherapy – 2 week washout with 1% topical hydrocortisone, oral steroids above 10 mg – 30 day washout, unless subject has Addison’s disease or adrenal insufficiency
• Subjects who are refractory to at least one of the standard therapies used to treat stage IA, IB or IIA CTCL such as oral steroids, high-dose topical steroids, topical nitrogen mustard, bexarotene, PUVA therapy, electron beam radiation, biological response modifiers or oral methotrexate
• Subjects must be willing to abstain from therapeutic sunbathing, phototherapy, tanning beds, etc. for the duration of the study

Exclusion Criteria

• Subjects who have MF (T3 cutaneous tumors or T4 exfoliative erythroderma) stage IIB – IVB
• Subjects who are unable to tolerate extracorporeal volume loss i.e., severe cardiac disease/anemia
• Subjects with deterioration of renal function who have a serum creatinine level greater than 3.0 mg/dL
• Subjects with lipemic plasma > 500 ng/dL, uncontrolled diabetes, history of liver damage (2.5 x normal alanine transaminase [ALT], aspartate transaminase [AST]), porphyria, lupus, positive tests for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody or hepatitis B surface antigen, severe emotional, behavioral or psychiatric problems that, in the opinion of the investigator, would result in poor compliance with the treatment regimen, and idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen compounds, heparin, or citrate
• Subjects on oral prednisone therapy or high potency topical steroids
• Subjects who are pregnant or nursing a child