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Investigator(s):
Maria L. Turner, M.D. Principal Investigator Phone: 301-496-7737	Heidi Kong, M.D. Protocol Chair Phone: 301-402-7452
Referral Contact(s):
Susan Booher, M.S., R.N. Research Nurse Phone: 301-402-1474 boohers@mail.nih.gov

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Primary Eligibility:

• Pathologically confirmed diagnosis of Cutaneous T-Cell non-Hodgkin’s Lymphoma (CTCL) based on skin biopsy
• Stage IA, IB, or IIA
• ≥ 18 years of age
• Evaluable disease
• ECOG performance 0-1
• At least 2 weeks since prior and no concurrent light therapy (i.e., PUVA or UVB)
• At least 2 weeks since prior and no other concurrent topical therapies (i.e., corticosteroids or nitrogen mustard) to designated target sites or to areas to be treated with study drug; concurrent topical therapy to nonadjacent, nontargeted CTCL lesions allowed
• No concurrent medications that may prolong the QTc
• No concurrent complementary or alternative medications for the targeted lesions
• More than 4 weeks since prior and no concurrent systemic histone deacetylase inhibitor therapy
• More than 4 weeks since prior chemotherapy; 6 weeks for nitrosoureas or mytomycin C; 8 weeks for UCN-01
• No prior or concurrent CNS metastasis
• HIV negative
• Not pregnant or nursing
• Must use effective contraception
• Ejection fraction normal by ECHO
• ANC ≥ 1,000/mm³
• Neutrophil count ≥ 1,000/mm³
• Platelets ≥ 100,000/mm³
• Bilirubin ≤ 1.5 x upper limit of normal (ULN)
• AST ≤ 3 x ULN
• Creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL/min
• No QTc prolongation or rhythm abnormality by EKG
• No other malignancies within the past 5 years except for any of the following:
• Malignancies that have been curatively treated and without recurrence
• Nonmelanoma skin cancer
• Low-grade cervical cancer
• Prostate cancer
• No uncontrolled illness including but not limited to:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• Psychiatric illness
• Social situations that would limit compliance with study requirements

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Treatment Plan:

This is a 2-part, nonrandomized, pilot, dose-escalation, open-label study.

Part I:

• Patients apply topical romidepsin to the designated target lesion 3 times weekly for 4 weeks in the absence of disease progression or unacceptable toxicity
• Cohorts of 3-6 patients receive escalating doses of topical romidepsin until the maximum tolerated dose (MTD) is determined
• The MTD is defined as the dose preceding that at which 1 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT)

Part II:

• Patients apply topical romidepsin to designated treatment sites as in Part I at the MTD determined in Part I
• Cohorts of 3-6 patients receive topical romidepsin to escalating body surface area (BSA) until the MTD is determined
• The MTD is defined as the dose (i.e., the drug concentration used and the percentage of BSA treated) preceding that at which 1 of 3 or 2 of 6 patients experience DLT
• Patients undergo blood collection and skin biopsy periodically for correlative and pharmacokinetic studies
• After completion of study treatment, patients are followed periodically for up to 4 weeks

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 12/4/08
Updated: 2/12/08