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Forodesine in the Treatment of Cutaneous T-Cell Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Forodesine in the Treatment of Cutaneous T-Cell Lymphoma

Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma

NCT00501735•BioCryst Pharmaceuticals

Summary

This is a Phase II, non-randomized, open-label, single-arm trial that will be conducted at up to 50 sites in North America, Europe and Australia. This study is designed to assess objective response (OR) \[complete response (CR) or partial response (PR)\] in subjects with cutaneous manifestations of CTCL with a requirement for maintenance of such objective response for at least 28 days in subjects with stage IIB, III, and IVA CTCL. Additionally, this study will evaluate the safety and tolerability of CTCL subjects Stages IB, IIA, IIB, III, or IVA treated with oral forodesine.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males or non-pregnant females aged ≥18 years;
•Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or Sezary syndrome, documentation of diagnosis by histologic examination should be available;
•Subjects with CTCL stages IB, IIA, IIB, III, or IVA at the screening visit (i.e. stage refers to stage at study entry) and who have persistent, progressive, or recurrent disease during or following treatment with at least three forms of systemic therapy, one of which must have been oral bexarotene, unless treatment with oral bexarotene was not tolerated or was medically contraindicated;
•Anticipated life expectancy greater than 6 months;
•Performance status of 0, 1, or 2 by Eastern Cooperative Oncology Group (ECOG) criteria;
•Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of study treatment;
•Females of childbearing potential and sexually active males, if indicated, must be willing and able to use method(s) of contraception that are adequate to prevent or minimize the risk of pregnancy for the duration of the study;
•Written informed consent to participate in the study.

Exclusion Criteria

•Proven or suspected extracutaneous visceral CTCL involvement (M1) (CTCL stage IVB) (note: presence of lymphadenopathy is permitted);
•Previous treatment with Forodesine;
•ECOG performance status \>2;
•Concomitant use of any anti-cancer therapy or immune modifier;
•Concomitant use of any investigational agent or device;
•Concurrent treatment with any other anti-CTCL therapy, or radiation therapy \[topical corticosteroids (classes 1 and 2 prohibited) or low dose oral corticosteroids (≤10 mg/day prednisone or equivalent) will not be excluded, but if used, must be a stable dose and schedule during the four weeks immediately prior to study entry\];
•Use of previous therapies for CTCL within the timeframes specified below:
•1. Phototherapy in the previous 30 days;
•2. Electron beam therapy, photopheresis, systemic anticancer therapy, interferon therapy, or other investigational therapy in the previous 30 days;
•3. Oral retinoid (including bexarotene) in the previous 30 days
+25 more criteria

Locations (41)

University of Alabama at Birmingham, Comprehensive Cancer Ctr

Birmingham, Alabama, United States

Stanford University Medical Center

Stanford, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

LSU Health Sciences Center, Feist-Weiller Cancer Center

Shreveport, Louisiana, United States

Boston Medical Center

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Hackensack University Medical Ctr

Hackensack, New Jersey, United States

Upstate Medical University

Syracuse, New York, United States

Key Dates

Start Date

July 1, 2007

Primary Completion Date

July 1, 2010

Completion Date

December 1, 2011

Last Updated

January 23, 2012

Enrollment

144

ACTUAL participants

Conditions

Cutaneous T-cell Lymphoma (CTCL),

Interventions

Forodesine 200 mg

DRUG