Trial Search Results

Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma

The purpose of this study is to evaluate the clinical effect of SHAPE when it is administered topically daily or twice daily for 26 consecutive weeks to skin lesions in patients with stage IA, IB, or IIA Cutaneous T-cell Lymphoma

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

TetraLogic Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: SHAPE

Phase:

Phase 2

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCO
650-498-7061
Not Recruiting