An Open Label Study to Evaluate the Safety and Efficacy of Mechlorethamine(MCH) 0.04% Formulation in Mycosis Fungoides

Trial ID or NCT#

NCT00535470

Status

not recruiting iconNOT RECRUITING

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.

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

Eligibility Criteria

Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - Pregnant or nursing females, or males and females of childbearing potential, not using an effective means of contraception

Investigator(s)

Sunil Arani Reddy
Sunil Arani Reddy
Medical oncologist, Cutaneous oncology specialist
Clinical Associate Professor, Medicine - Oncology
Richard Hoppe
Richard Hoppe
Radiation oncologist
Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology

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Contact

Cancer Clinical Trials Office
650-498-7061