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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

Phase 4
18 Years
Not Enrolling
Cutaneous T Cell Lymphoma, Mycosis Fungoides

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Trial Information

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

Objectives: 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

Methodology: Single-arm, open-label treatment using UVAR XTS Photopheresis System. Treatment
consists of two photopheresis treatments on successive days every 4 weeks for six months.
Those patients completing the first 6-month period may be continued on photopheresis for a
6-month follow-up period. Patients who do not respond to photopheresis therapy after 6
months may have concurrent therapy with low dose bexarotene and interferon added as outlined
in the protocol.

Number of Patients (Planned and Analyzed): The study plan is for a minimum of 50 patients

Diagnosis and Main Criteria for Inclusion: Male or female patients with CTCL diagnosis of
stage IA, IB or IIA with measurable skin lesions (patches or plaques) and a minor blood
abnormality. Patients must be refractory to at least one treatment for early stage CTCL
such as PUVA, Electron beam, oral steroids, high potency topical steroid, topical nitrogen
mustard, methotrexate, interferon, or bexarotene.

Test Product, Dose and Mode of Administration, Batch or Lot Number: UVADEX liquid
methoxsalen 20mcg/mL in conjunction with the UVAR XTS Photopheresis System. UVADEX is
injected into the photoactivation bag during photopheresis therapy in accordance with the
approved drug package insert and UVAR XTS operator's manual. UVADEX dose is less than 200mcg
per treatment.

Duration of Treatment: The study will consist of 2 treatment periods, a 6-month initial
period and a 6-month follow-up period where photopheresis therapy may continue.

Criteria for Evaluation:

Efficacy: The primary endpoint will be the overall response based on skin-weighted
assessment. Secondary endpoints will also include time to response, duration of response,
and a "Quality of Life " assessment. The size and number of lymph nodes and flow cytometry
analyses will also be considered. Experienced skin observers will perform skin scores on
each patient at enrollment. Skin scores will be recorded as the percentage of the patient's
body involved with patch or plaque lesions. A successful response to therapy will be
patients who have a greater than 50% improvement in skin involvement (PR) or complete skin
improvement (CR) without worsening in nodes, blood or visceral organs. Patients with
25%-50% improvement will be considered as minor response (MR), + or - 25% will be SD, and PD
will be defined as 25% worsening from baseline.

Safety: Safety is assessed by the incidence and intensity of adverse events, whether
clinical or based on laboratory results.

Statistical Methods: The primary endpoint will be the proportion of patients who have CR and
PR of their skin lesions.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint will be the overall response based on skin-weighted assessment.

Outcome Description:

The overall skin repsonse will be assessed at 6month and will consist of an experts assessment of the % of skin involvement at baseline and 6 months.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Madeleine Duvic, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2004

Completion Date:

February 2009

Related Keywords:

  • Cutaneous T Cell Lymphoma
  • Mycosis Fungoides
  • ECP
  • Photopheresis
  • CTCL
  • Cutaneous T Cell Lymphoma
  • Mycosis Fungoides
  • Lymphoma
  • Mycoses
  • Mycosis Fungoides
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous



MD Anderson Cancer Center Houston, Texas  77030-4096
Boston Medical Center Boston, Massachusetts  02118
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
University of Minnesota Minneapolis, Minnesota  55455
University of Pittsburgh Pittsburgh, Pennsylvania  15261
Rush-Presbyterian Hospital Chicago, Illinois  60612
University Hospital of Cleveland/Case Western Reserve University Cleveland, Ohio  44106