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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03288818
Other study ID # 16C.514
Secondary ID
Status Withdrawn
Phase Phase 2
First received September 18, 2017
Last updated January 25, 2018
Start date August 2018
Est. completion date December 2021

Study information

Verified date January 2018
Source Thomas Jefferson University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Documentation of diagnosis as evidenced by one or more clinical features consistent with mycosis fungoides cutaneous T-cell lymphoma

- Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with requirements of the study

- Skin biopsy specimen of representative lesion obtained at screening of study and deemed diagnostic of mycosis fungoides by principal investigator

- Mycosis fungoides patients that have stage T2-4 N0-1 M0B0 disease

- Availability of subject to be observed for up to 18 months post-screening evaluation

- Life expectancy greater than 6 months

Exclusion Criteria:

- Pregnant or breast-feeding females

- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data

- Patients diagnosed with Sezary syndrome; Sezary syndrome is equivalent to mycosis fungoides that develops to stage IVA/B with B2 (high blood tumor burden) involvement, and as such requires a more aggressive treatment regimen than Valchlor or TSEBT

- Underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of the patient to undergo treatment

- Minimum 3 weeks since prior systematic treatment or phototherapy

- Exclusion of people that do not understand the risks, such as decisionally-impaired individuals, prisoners, and vulnerable populations

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Mechlorethamine Hydrochloride Gel
Given topically
Procedure:
Total Skin Electron Beam Radiation Therapy
Undergo low dose (TSEBT) Total Skin Electron Beam Therapy

Locations

Country Name City State
United States Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University Actelion

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to progression Will be evaluated using the Kaplan-Meier estimator of the survival curves. Up to week 54
See also
  Status Clinical Trial Phase
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