An Open Label Study to Evaluate the Safety and Efficacy of Mechlorethamine(MCH) 0.04% Formulation in Mycosis Fungoides
This study has been completed.
Sponsor:
Yaupon Therapeutics
Information provided by (Responsible Party):
Yaupon Therapeutics
ClinicalTrials.gov Identifier:
NCT00535470
First received: September 24, 2007
Last updated: August 7, 2012
Last verified: August 2012
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Purpose
To evaluate the efficacy and safety of topical application of MCH 0.04% in a propylene glycol ointment (PG)in patients with stage I or IIA MF previously treated with MCH 0.02% in a PG or AP ointment who did not achieve a complete response.
| Condition | Intervention | Phase |
|---|---|---|
|
Mycosis Fungoides |
Drug: 0.04% Mechlorethamine gel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Study to Evaluate the Safety and Efficacy of Nitrogen Mustard (Mechlorethamine - MCH) 0.04% Formulation in Patients With Stage I-IIA Mycosis Fungoides Who Have Completed 12 Months Treatment Without a Complete Response |
Resource links provided by NLM:
Further study details as provided by Yaupon Therapeutics:
Primary Outcome Measures:
- Evaluate the efficacy of topical application of NM 0.04% in a propylene glycol ointment (PG) in patients with stage I or IIA MF [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Evaluate the tolerability and safety of topical application of NM 0.04% ointment formulations in patients with stage I or IIA MF [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 100 |
| Study Start Date: | July 2007 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Open label 0.04% Mechlorethamine gel
|
Drug: 0.04% Mechlorethamine gel
Mechlorethamine 0.04% PG applied to affected skin areas (lesions) once daily for up to seven (7) months. The frequency of application may be adjusted for toxicity. After seven (7) months, they will be terminated from the study.
Other Name: Nitrogen Mustard 0.04%
|
Detailed Description:
This is a multi-center, open-label study of patients with previously treated stage I (IA and IB) or IIA MF who have not received a complete response after completing 12 months of treatment in clinical trial (2005NMMF-201-US)to either 0.02% MCH PG or 0.02% MCH in Aquaphor (AP) ointment formulations.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have completed the treatment phase of the Yaupon Therapeutics-sponsored Phase II Pivotal study of MCH 0.02% in either the PG or AP formulation and have not achieved a complete response.
Exclusion Criteria:
- Pregnant or nursing females, or males and females of childbearing potential, not using an effective means of contraception
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535470
Locations
| United States, California | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305 | |
| United States, Illinois | |
| Northwestern University-Dept. of Dermatology | |
| Chicago, Illinois, United States, 61611 | |
| United States, New York | |
| NYU Medical Center Dept. of Dermatology | |
| New York, New York, United States, 10016 | |
| Columbia University, Dept of Dermatology | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Oklahoma | |
| Oklahoma University | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| United States, Texas | |
| University of Texas, Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| The University of Texas, M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Utah Clinical Trials, LLC | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53791 | |
Sponsors and Collaborators
Yaupon Therapeutics
Investigators
| Principal Investigator: | Stuart Lessin, M.D. | Fox Chase Cancer Center |
More Information
No publications provided
| Responsible Party: | Yaupon Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00535470 History of Changes |
| Other Study ID Numbers: | 2007NMMF-202-US |
| Study First Received: | September 24, 2007 |
| Last Updated: | August 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Mycoses Mycosis Fungoides Lymphoma, T-Cell, Cutaneous Lymphoma, T-Cell Lymphoma, Non-Hodgkin Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Mechlorethamine Nitrogen Mustard Compounds Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013