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Photopheresis as an Interventional Therapy for the Treatment of CTCL (Cutaneous T-Cell Lymphoma, Mycosis Fungoides) Stage 1A, 1B, 2A
This study is currently recruiting participants.
Verified by Therakos, September 2005
First Received: September 13, 2005   Last Updated: November 20, 2006   History of Changes
Sponsored by: Therakos
Information provided by: Therakos
ClinicalTrials.gov Identifier: NCT00221039
  Purpose

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.


Condition Intervention Phase
Cutaneous T Cell Lymphoma
Mycosis Fungoides
Drug: UVADEX (methoxsalen) Solution with UVAR XTS Photopheresis
Phase IV

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Therakos:

Primary Outcome Measures:
  • The primary endpoint will be the overall response based on skin-weighted assessment.

Secondary Outcome Measures:
  • Time to response
  • Duration of response
  • Quality of life

Estimated Enrollment: 50
Study Start Date: September 2004
Estimated Study Completion Date: September 2007
Detailed Description:

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 disease. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221039

Contacts
Contact: Madeleine Duvic, MD 713-745-1113 mduvic@mdanderson.org
Contact: Frank Strobl, MD, PhD 610-280-1106 fstrobl@tksus.jnj.com

Locations
United States, Illinois
Rush-Presbyterian Hospital Recruiting
Chicago, Illinois, United States, 60612
Contact: Michael Tharp, MD     312-563-4001     michael_d_tharp@rush.edu    
Contact: Ruby Page, RN     312-563-4001     ruby_page@rush.edu    
Principal Investigator: Michael Tharp, MD            
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Marie-France Demierre, MD     617-638-7629     mariefrance.demierre@bmc.org    
Contact: Marsha Stevens, RN     617-638-7629     marsha.stevens@bmc.org    
Principal Investigator: Marie-France Demierre, MD            
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Kimberly Bohjanen, MD     612-625-4973     bohja003@umn.edu    
Contact: Cathy Boeck, RN     612-625-4973     boeck001@umn.edu    
Principal Investigator: Kimberly Bohjanen, MD            
United States, Ohio
University Hospital of Cleveland/Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Elma Baron, MD     216-368-4971     edb4@po.cwru.edu    
Contact: Heather Scull, MS     216-368-0212     heather.scull@case.edu    
Principal Investigator: Elma Baron, MD            
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Larisa Geskin, MD     412-624-3782     geskinlj@upmc.edu    
Contact: Sue McCann, RN     412-648-6530     mccannsa@upmc.edu    
Principal Investigator: Larisa Geskin, MD            
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: John Zic, MD     615-936-1133     john.zic@vanderbilt.edu    
Contact: Brigitta Brannon, CCRC     615-343-4365     brigitta.brannon@vanderbilt.edu    
Principal Investigator: John Zic, MD            
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Madeleine Duvic, MD     713-792-4578     mduvic@mdanderson.org    
Contact: Olga Heinle, RN     713-794-1450     oeheinle@mdanderson.org    
Principal Investigator: Madeleine Duvic, MD            
Sponsors and Collaborators
Therakos
Investigators
Principal Investigator: Madeleine Duvic, MD M.D. Anderson Cancer Center
  More Information

No publications provided

Study ID Numbers: ECTCL1
Study First Received: September 13, 2005
Last Updated: November 20, 2006
ClinicalTrials.gov Identifier: NCT00221039     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Therakos:
ECP
Photopheresis
CTCL
Cutaneous T Cell Lymphoma
Mycosis Fungoides

Study placed in the following topic categories:
Immunoproliferative Disorders
Sezary Syndrome
Mycosis Fungoides
Mycoses
Lymphatic Diseases
Photosensitizing Agents
Radiation-Sensitizing Agents
Cutaneous T-cell Lymphoma
Methoxsalen
Lymphoma, T-Cell
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Physiological Effects of Drugs
Sezary Syndrome
Mycosis Fungoides
Pharmacologic Actions
Mycoses
Lymphatic Diseases
Photosensitizing Agents
Neoplasms
Radiation-Sensitizing Agents
Methoxsalen
Therapeutic Uses
Lymphoma, T-Cell
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Dermatologic Agents
Lymphoma
Lymphoma, T-Cell, Cutaneous

ClinicalTrials.gov processed this record on September 11, 2009