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

• Status: Completed
• Trial end date: 2011-04-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center; Mallinckrodt
• Collaborators: Boston Medical Center; Case Western Reserve University; M.D. Anderson Cancer Center; Mallinckrodt; Rush University Medical Center; University of Minnesota; University of Minnesota - Clinical and Translational Science Institute; University of Pittsburgh; Vanderbilt University Medical Center
• Treatments: Methoxsalen

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.