Topical Romidepsin in Treating Patients With Stage I or Stage II Cutaneous T-Cell Non-Hodgkin's Lymphoma - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00477698

Purpose

RATIONALE: Topical romidepsin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of topical romidepsin in treating patients with stage I or stage II cutaneous T-cell non-Hodgkin's lymphoma.

Condition	Intervention	Phase
Lymphoma	Drug: romidepsin Procedure: biopsy Procedure: pharmacological study	Phase I

MedlinePlus related topics: Cancer Fungal Infections Lymphoma

Drug Information available for: FR 901228

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
Official Title:	Phase I Study of Topical Romidepsin in Early Stage Cutaneous T-Cell Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Maximum tolerated dose of romidepsin [ Designated as safety issue: Yes ]
Skin toxicity [ Designated as safety issue: Yes ]
Systemic toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Histone acetylation in treated skin [ Designated as safety issue: No ]
Clinical efficacy [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	April 2007

Detailed Description:

OBJECTIVES:

Primary

Determine the maximum tolerated dose of topical romidepsin in patients with stage IA, IB, or IIA cutaneous T-cell non-Hodgkin's lymphoma.

Secondary

Determine histone acetylation in the treated skin of patients receiving this drug.
Determine the clinical efficacy of this drug in these patients.
Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.

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

Part 1: 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 2: Patients apply topical romidepsin to designated treatment sites as in part 1 at the MTD determined in part 1.

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.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Pathologically confirmed cutaneous T-cell non-Hodgkin's lymphoma (CTCL) based on skin biopsy
- Stage IA, IB, or IIA disease
Evaluable disease
No prior or concurrent CNS metastases

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
ANC ≥ 1,000/mm^3
Platelet count ≥ 100,000/mm^3
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST ≤ 3 times ULN
Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Ejection fraction normal by ECHO
No QTc prolongation (i.e., QTc > 480 msec) 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 HIV positivity
No other uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

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 mitomycin C and 8 weeks for 7-hydroxystaurosporine)
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, nontarget CTCL lesions allowed
No concurrent medications that may prolong the QTc
No concurrent complementary or alternative medications for the target lesions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477698

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Maria L. Turner, MD

NCI - Dermatology Branch

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000546651, NCI-07-C-0133
Study First Received:	May 23, 2007
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00477698
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma

stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
recurrent mycosis fungoides/Sezary syndrome

Study placed in the following topic categories:

Sezary syndrome
Immunoproliferative Disorders
Cutaneous T-cell lymphoma
Lymphoma, small cleaved-cell, diffuse
Romidepsin
Sezary Syndrome
Mycosis Fungoides
Recurrence

Mycoses
Lymphatic Diseases
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009