©2022 Stanford Medicine
Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma
Not Recruiting
Trial ID: NCT02213861
Purpose
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).
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
Stanford Investigator(s)
Sunil Arani Reddy
Clinical Associate Professor, Medicine - Oncology
Eligibility
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
Intervention(s):
drug: SHAPE
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCO
650-498-7061