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Photopheresis as an Interventional Therapy for the Treatment of CTCL (Cutaneous T-Cell Lymphoma, Mycosis Fungoides) Stage 1A, 1B, 2A
Trial ID: NCT00221039
The study objective is to demonstrate that the UVADEX® Sterile Solution formulation of methoxsalen used in conjunction with the UVAR XTS Photopheresis System can have a clinical effect on the skin manifestations of CTCL (mycosis fungoides) in early stage disease.
UVADEX Sterile Solution in Conjunction With the UVAR XTS Photopheresis System as an Interventional Therapy for the Treatment Of CTCL (Mycosis Fungoides) in Patients With TMN Classification Stage 1A, 1B, 2A
- Patients are to be greater than 40 kg body weight.
- Patients must have adequate veins to provide intravenous access.
- Women who are not pregnant, lactating, or of childbearing potential. Lack of
childbearing potential was defined as:
- Being post-menopausal
- Being surgically sterile
- Practicing contraception
- Patients with childbearing potential had to have a negative serum human chorionic
gonadotropin (HCG) upon entrance into the study.
- Patients must be willing to adhere to the protocol, and sign an Informed Patient
Consent Form prior to entry into the study.
- Patients must not be on any other investigational device/drug treatment.
- Patients with the diagnosis of mycosis fungoides (MF) including a skin biopsy
consistent with MF (atypical epidermotrophic or folliculocentric T-cells).
- Appropriate staging as IA, IB or IIA : T1 or T2 (patches or plaques) with measurable
- IA patients must show evidence of a minor blood abnormality by morphology or
- For IIA patients - clinically significant nodes (1.5 cm) must have lymph node
biopsy showing dermatopathic nodes or no involvement.
- Patients must be willing and able to discontinue concomitant medications for MF.
- Patients currently taking the following drugs must discontinue medication prior to
enrollment in the trial:
- Psoralens and ultraviolet A (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 patient has Addison's disease
or adrenal insufficiency
- Patients must be 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,
mechlorethamine (HN2), bexarotene, PUVA therapy, electron beam radiation, biological
response or oral methotrexate.
- Patients must abstain from therapeutic sunbathing, tanning beds, etc. for the duration
of the study.
- Patients who have MF (T3 cutaneous tumors or T4 exfoliative erythroderma) Stage IIB -
IVB, ie. no pathological node or visceral involvement.
- Patients who are unable to tolerate extracorporeal volume loss (e.g., severe cardiac
disease or severe anemia or weight < 40 kg).
- Patients with recent (within three months) deterioration of renal function who have a
serum creatinine level greater than 3.0 mg/dL.
- Patients with lipemic plasma > 500 ng/dL or uncontrolled diabetes.
- Patients with a history of liver damage (2.5 x normal ALT, AST) or porphyria.
- Patients with positive tests for HIV antibody, hepatitis C virus (HCV) antibody or
hepatitis B surface antigen.
- Patients on oral prednisone therapy or full body or high potency topical steroids.
- Women who are pregnant or nursing a child.
- Patients with severe emotional, behavioral or psychiatric problems that, in the
opinion of the investigator, would result in poor compliance with the treatment
- Patients who exhibit idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen
compounds, heparin, or citrate.
- Patients with previous exposure to photopheresis therapy.
- Patients who use tanning beds or are receiving phototherapy.
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