Photopheresis as an Interventional Therapy for the Treatment of CTCL (Cutaneous T-Cell Lymphoma, Mycosis Fungoides) Stage 1A, 1B, 2A

Completed · Phase 4

Conditions studied: Cutaneous T Cell Lymphoma, Mycosis Fungoides

In brief

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.

Key facts

Study ID

NCT00221039

Run by

M.D. Anderson Cancer Center

People needed

7

Starts

2004-04-02

Expected to finish

2011-04-05

Last updated by the study team

2018-08-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 lesions.
• IA patients must show evidence of a minor blood abnormality by morphology or laboratory assessment.
• 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.

You may not qualify if…

• 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 regimen.
• 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.

Where it is running

• Rush-Presbyterian Hospital — Chicago, Illinois, United States
• Boston Medical Center — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• University Hospital of Cleveland/Case Western Reserve University — Cleveland, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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