The purpose of this study is to evaluate the efficacy, safety and tolerability of SHAPE administered topically to skin lesions in patients with early-stage cutaneous T-cell lymphoma (CTCL).
This is a Phase 2, multicenter, open-label, randomized study to evaluate the efficacy and safety of SHAPE Gelled Solution applied topically daily or twice daily for 26 consecutive weeks to specified skin lesions in patients with Stage IA, IB or IIA CTCL. Patients responding to treatment will be allowed to continue on study for a maximum of 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
topical gel
Stanford Cancer Center
Stanford, California, United States
Northwestern Medical Group
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Lesion severity using CAILS (Composite Assessment of Index Lesion Severity)
Time frame: Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).
modified Severity Weighted Assessment Tool (mSWAT)
Time frame: Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks).
Patient assessment of pruritis using a Visual Analog Scale (VAS)
Time frame: Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).
Skindex-29 Quality of Life Tool
Time frame: Every 4 weeks for 26 weeks
modified Composite Assessment of Index Lesion Severity (CAILS)
Time frame: Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States