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Brief Title: Low Dose Total Skin Electron Beam Radiation Therapy and Mechlorethamine Hydrochloride Gel in Treating Patients With Mycosis Fungoides
Official Title: IIS: Phase II Study of Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides
Study ID: NCT03288818
Brief Summary: This phase II trial studies how well low dose total skin electron beam radiation therapy and mechlorethamine hydrochloride gel work in treating patients with mycosis fungoides. Total skin electron beam radiation therapy uses high energy x-rays directed at the entire surface of the body to kill cancer cells and shrink tumors. Mechlorethamine hydrochloride gel may help patients in remission of disease, reduction in disease staging, and enhanced quality of life. Giving total skin electron beam radiation therapy and mechlorethamine hydrochloride gel may work better in treating patients with mycosis fungoides.
Detailed Description: PRIMARY OBJECTIVES: I. To assess the time to progression of patients treated with total skin electron beam therapy (TSEBT) followed by the year-long maintenance mechlorethamine hydrochloride gel (Valchlor) regimen. SECONDARY OBJECTIVES: I. To assess the response rate (complete response \[CR\] and partial response \[PR\]) of patients treated with total skin electron beam therapy (TSEBT) followed by the year-long maintenance Valchlor regimen.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Name: Joya Sahu, MD
Affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
Role: PRINCIPAL_INVESTIGATOR