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.

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborator: Boston Medical Center

Stanford Investigator(s):


  • Drug: Methoxsalen+ECP


Phase 4


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

      - 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

   - 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


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Natalie Viakhireva
Not Recruiting