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Sponsored by: |
Yaupon Therapeutics |
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Information provided by: | Yaupon Therapeutics |
ClinicalTrials.gov Identifier: | NCT00168064 |
This study will evaluate the efficacy, tolerability and safety of the topical application of nitrogen mustard (NM) ointment formulations in patients with stage I or IIA mycosis fungoides (MF).
Condition | Intervention | Phase |
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Mycosis Fungoides |
Drug: Nitrogen Mustard |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Pivotal Trial to Evaluate the Safety and Efficacy of Nitrogen Mustard (NM) 0.02% Ointment Formulations in Patients With Stage I or IIA Mycosis Fungoides (MF) |
Estimated Enrollment: | 118 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 (NM 0.02% PG): Active Comparator
To evaluate the tolerability and safety of topical application of NM 0.02% ointment formulations in patients with stage I or IIA MF
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Drug: Nitrogen Mustard
All affected areas (lesions) are to be treated once daily for twelve months with NM 0.02% PG or NM 0.02% AP ointment
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2 (NM 0.02% AP): Active Comparator
To evaluate the tolerability and safety of topical application of NM 0.02% ointment formulations in patients with stage I or IIA MF.
|
Drug: Nitrogen Mustard
All affected areas (lesions) are to be treated once daily for twelve months with NM 0.02% PG or NM 0.02% AP ointment
|
The successful use of nitrogen mustard as a topical agent in the treatment of mycosis fungoides, a form of cutaneous T-cell lymphoma, was first reported in the late 1950s, and provided a rationale for skin-directed chemotherapy that minimized systemic toxicity. Over the past 45 years, multiple investigators have demonstrated the safety and efficacy of topically applied NM in the treatment of mycosis fungoides. This study will evaluate the efficacy, tolerability and safety of topical application of NM ointment formulations in patients with stage I or IIA MF.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stuart Lessin, M.D. | 215-728-2191 | stuart.lessin@fccc.edu |
United States, California | |
Stanford University Medical Center | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Youn Kim, M.D. 650-723-6316 younkim@stanford.edu | |
United States, Illinois | |
Northwestern University - Dept. of Dermatology | Recruiting |
Chicago, Illinois, United States, 61611 | |
Contact: Joan Guitart, M.D. 312-695-1413 j-guitart@northwestern.edu | |
Contact: Miquel Pena, M.D. 312-695-4761 Miguel-pena@northwestern.edu | |
United States, Massachusetts | |
Brigham & Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Alexa B. Kimball, M.D. 617-726-5066 akimball@partners.org | |
Contact: Gaby Rolz-Cruz 617-525-8254 grolcruz@partners.org | |
United States, New York | |
NYU Medical Center Dept. of Dermatology | Recruiting |
New York, New York, United States, 10016 | |
Contact: Bruce Strober, M.D., Ph.D. 212-263-5244 strober@nyc.rr.com | |
Columbia University, Dept. of Dermatology | Recruiting |
New York, New York, United States, 10032 | |
Contact: Elizabeth Knobler, M.D. 212-305-7293 | |
Contact: Julian Mackay-Wiggin, M.D., M.S. 212-305-6953 jc299@columbia.edu | |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Elise A. Olsen, M.D. 919-668-5613 olsen001@mc.duke.edu | |
United States, Oklahoma | |
Oklahoma University | Recruiting |
Tulsa, Oklahoma, United States, 74104 | |
Contact: Mark F. Naylor, M.D. 918-743-4821 mark-naylor@ouhsc.edu | |
United States, Pennsylvania | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Alain H. Rook, M.D. 215-662-7610 arook@mail.med.upenn.edu | |
Fox Chase Cancer Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19111-2497 | |
Contact: Stuart Lessin, M.D. 215-728-2191 S_Lessin@fccc.edu | |
Principal Investigator: Stuart Lessin, M.D. | |
United States, Texas | |
The University of Texas, M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Madeleine Duvic, M.D. 713-745-4615 mduvic@mdanderson.org | |
University of Texas, Southwestern Medical Center | Recruiting |
Dallas, Texas, United States, 75390 | |
Contact: Christina Carrigan, R.N. 214-645-8968 Christina.Carrigan@UTSouthwestern.edu | |
Principal Investigator: Amit G. Pandya, M.D. | |
United States, Utah | |
Utah Clinical Trials, LLC | Recruiting |
Salt Lake City, Utah, United States, 84107 | |
Contact: Christopher B. Hansen, M.D. 801-268-1610 chansen@utahclinicaltrials.com | |
Contact: Christopher D. Hansen, M.D. 801-268-1610 dhansen@utahclinicaltrials.com | |
Principal Investigator: Christopher Hull, M.D. | |
United States, Wisconsin | |
University of Wisconsin | Recruiting |
Madison, Wisconsin, United States, 53791 | |
Contact: Gary Wood, M.D. 608-287-2620 gwood@dermatology.wisc.edu | |
Contact: Ladan Mostaghimi, M.D. 608-287-2620 | |
Principal Investigator: Gary Wood, M.D. |
Study Director: | Stuart Lessin, M.D. | Fox Chase Cancer Center, Philadelphia, PA |
Responsible Party: | Yaupon Therapeutics, Inc. ( Stuart R. Lessin, M.D., Principal Investigator ) |
Study ID Numbers: | 2005NM-201-US |
Study First Received: | September 7, 2005 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00168064 |
Health Authority: | United States: Food and Drug Administration |
Mycosis Fungoides Nitrogen Mustard Cutaneous T-Cell Lymphoma CTCL - Mycosis Fungoides |
Sezary syndrome Immunoproliferative Disorders Cutaneous T-cell lymphoma Sezary Syndrome Mycosis Fungoides Mycoses Lymphatic Diseases |
Lymphoma, T-Cell Mechlorethamine Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Nitrogen Mustard Compounds Lymphoma, T-Cell, Cutaneous |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Pharmacologic Actions |