Trial Search Results
Photopheresis as an Interventional Therapy for the Treatment of CTCL (Cutaneous T-Cell Lymphoma, Mycosis Fungoides) Stage 1A, 1B, 2A
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.
Stanford is currently not accepting patients for this trial.
M.D. Anderson Cancer Center
Collaborator: Boston Medical Center
- Drug: Methoxsalen+ECP
- 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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study