Clinical trial NCT02213861: Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma
Official title: A Randomized Phase 2 Study to Evaluate Three Treatment Regimens of SHAPE, a Histone Deacetylase Inhibitor, in Patients With Stage IA, IB or IIA Cutaneous T-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cutaneous T-Cell Lymphoma (CTCL)
Keywords: CTCL
Cutaneous T-Cell Lymphoma
Early-stage
SHAPE
SHP-141
topical
Histone deacetylase inhibitor
CAILS
mSWAT
mycosis fungoides
Lead sponsor: TetraLogic Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-08-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Histological confirmation of CTCL; a documented verifiable biopsy report is required
* Documented clinical stage IA, IB or IIA CTCL
* Skin lesion involvement of at least 2% of BSA accessible for topical application of study drug
* ECOG performance status of 0-2

Exclusion Criteria:

* CTCL with histologic evidence of folliculotropic variant or large cell transformed CTCL
* Palpable lymph node ≥1.5 cm in diameter (unless the lymph node has been biopsied and designated as Stage IA-IIA disease)
* Co-existent second malignancy or history of prior solid organ malignancy within previous 5 years (excluding basal or squamous cell carcinoma, in situ carcinoma of the cervix (CIN3), papillary or follicular thyroid cancer or prostate cancer that has been treated curatively
* Any prior history of hematologic malignancy (other than CTCL) within past 5 years
* CTCL disease that is known to be refractory to systemic histone deacetylase inhibitors
* Prior or concurrent central nervous system (CNS) metastases
* History of or current major gastrointestinal, pulmonary, cardiovascular, genitourinary or hematologic disease, CNS disorders, infectious disease or coagulation disorders as determined by the Investigator
* Evidence of active Hepatitis B or C or HIV
* Circulating atypical cells of clinical significance

Primary outcomes:
measure: Lesion severity using CAILS (Composite Assessment of Index Lesion Severity)
timeFrame: Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).
Secondary outcomes:
measure: modified Severity Weighted Assessment Tool (mSWAT)
timeFrame: Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks).
measure: Patient assessment of pruritis using a Visual Analog Scale (VAS)
timeFrame: Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).
measure: Skindex-29 Quality of Life Tool
timeFrame: Every 4 weeks for 26 weeks
measure: modified Composite Assessment of Index Lesion Severity (CAILS)
timeFrame: Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks).
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Chicago
country: United States
facility: Northwestern Medical Group
state: Illinois
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
References:
citation: Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.