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Topical Romidepsin to Treat Early-Stage Cutaneous T-Cell Lymphoma

NCT01445340 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2019-12-17

No results posted yet for this study

Summary

Background:

* 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.

Objectives:

* 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.

Eligibility:

-Patients 18 of age and older with early-stage CTCL.

Design:

* 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.

Conditions

  • Mycosis Fungoides
  • Cutaneous T-Cell Lymphoma
  • Neoplasms

Interventions

DRUG

Romidepsin (FR901228)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Heidi H Kong, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-21
Completion
2012-06-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01445340 on ClinicalTrials.gov