Topical Romidepsin to Treat Early-Stage Cutaneous T-Cell Lymphoma
|ClinicalTrials.gov Identifier: NCT01445340|
Recruitment Status : Terminated
First Posted : October 3, 2011
Last Update Posted : March 20, 2018
- Cutaneous T-cell lymphoma (CTCL) is a rare, slow-growing form of skin cancer. The cancer cells are found in red, scaly patches that may sometimes itch.
- Early-stage CTCL is usually treated with topical therapies, which may lose effectiveness over time and have adverse effects, such as risk of secondary skin cancers and difficulty of use.
- Romidepsin is an experimental drug that, given through a vein, has improved CTCL in some patients with later stages of the disease.
- A topical ointment form of romidepsin may be helpful in treating early-stage CTCL.
- To determine the highest tolerated dose of topical romidepsin that can be given to patients with early-stage CTCL.
- To evaluate the effectiveness of topical romidepsin in patients with early-stage CTCL.
- To determine how the body handles topical romidepsin.
-Patients 18 of age and older with early-stage CTCL.
- Study Part 1: Successive groups of 3 patients are treated with increasingly higher concentrations of topical romidepsin until the highest tolerated dose is found.
- Study Part II: The highest tolerated dose, as determined in Part I, is applied to larger areas of skin in another group of patients.
- All study participants apply the study medicine to their skin three times a day for 4 weeks.
- During treatment, participants are monitored at weeks 2 and 4 with a history and physical examination, blood tests, electrocardiogram, skin biopsies and photographs of the skin.
- After stopping treatment, participants return to the clinic at weeks 6 and 8 for blood tests and to see how the study medication is affecting the body.
|Condition or disease||Intervention/treatment||Phase|
|Mycosis Fungoides Cutaneous T-Cell Lymphoma Neoplasms||Drug: Romidepsin (FR901228)||Phase 1|
- Romidepsin is a histone deacetylase inhibitor which has demonstrated efficacy and tolerability as an infusion in later stages of cutaneous T-cell lymphoma (CTCL).
- Early stages of CTCL are typically treated with skin-directed therapies, which may lose efficacy over time and have adverse effects (i.e. risk of secondary skin cancers, difficulty of use).
- A topical form of romidepsin may be helpful in the treatment of early-stage CTCL.
- Primary - To define the maximal tolerated dose (MTD) of topical romidepsin for early-stage CTCL when administered three times weekly, then escalated first in concentration, followed by increased frequency and lastly over increasing body surface areas.
- Secondary - To assess histone acetylation in topical romidepsin-treated skin.
- Secondary - To assess in a pilot fashion clinical efficacy of topical romidepsin in early stage cutaneous T-cell lymphoma.
- Secondary - To perform pharmacokinetic monitoring of blood levels of romidepsin in topically treated patients.
-Patients age greater than or equal to 18 with confirmed early-stage (stage IA, IB, or IIA) cutaneous T-cell lymphoma.
- A Cohorts of Three design to define the MTD of topical romidepsin in Aquaphor ointment initially applied overnight, three times weekly for 4 weeks, then escalated first in concentration, followed by increased frequency and lastly over increasing body surface areas.
- Skin toxicities, systemic toxicities, and disease response will be assessed throughout the study.
- The primary focus of the first part of the protocol will be to evaluate local skin toxicity, beginning with dose level 1 of 0.05 percent topical romidepsin on 25 cm(2) target area (0.005 mg/ cm(2). If tolerated, progress to higher dose levels of 0.25 percent (0.025 mg/ cm(2); dose level 2) and then 0.5 percent (0.05 mg/ cm(2); dose level 3) topical romidepsin on 25 cm(2) target area. Systemic toxicity will also be monitored.
- To date, we have completed the first 4 dose levels and have not yet established cutaneous MTD. To achieve this, we will proceed to the second part of the protocol, which will increase the concentration to 1%, then increase the frequency to daily application, then progress to 2% concentration, then 4% concentration, and then applying to progressively larger body surface areas. Our aim is to more fully address systemic toxicity by increasing drug concentration, application frequency, and body surface area (BSA) treated. We will utilize topical romidepsin at the MTD on increasing BSA (lesional & nonlesional skin): multiple lesions up to 3% BSA (dose level 4), multiple lesions up to 25% BSA (dose level 7A), 50% BSA (dose level 7B), and 75% or > BSA (dose level 7C).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Topical Romidepsin (Depsipeptide) in Early Stage Cutaneous T-Cell Lymphoma|
|Study Start Date :||April 21, 2007|
|Study Completion Date :||June 29, 2012|
- To define the maximal tolerated dose of topical romidepsin.
- To assess histone acetylation in topical romidepsin-treated skin, to assess in a pilot fashion clinical efficacy of topical romidepsin in early stage CTCL and to perform pharmacokinetic monitoring of blood levels of topical romidepsin.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01445340
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Heidi H Kong, M.D.||National Cancer Institute (NCI)|