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Sponsored by: |
Therakos |
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Information provided by: | Therakos |
ClinicalTrials.gov Identifier: | NCT00221039 |
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 |
Estimated Enrollment: | 50 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | September 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Women who are not pregnant, lactating, or of childbearing potential. Lack of childbearing potential was defined as:
Appropriate staging as IA, IB or IIA : T1 or T2 (patches or plaques) with measurable lesions.
Patients currently taking the following drugs must discontinue medication prior to enrollment in the trial:
Exclusion Criteria:
Contact: Madeleine Duvic, MD | 713-745-1113 | mduvic@mdanderson.org |
Contact: Frank Strobl, MD, PhD | 610-280-1106 | fstrobl@tksus.jnj.com |
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 |
Principal Investigator: | Madeleine Duvic, MD | M.D. Anderson Cancer Center |
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 |
ECP Photopheresis CTCL Cutaneous T Cell Lymphoma Mycosis Fungoides |
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 |
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 |