Forodesine in the Treatment of Cutaneous T-Cell Lymphoma

Completed · Phase 2

Conditions studied: Cutaneous T-cell Lymphoma (CTCL),

In brief

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.

Key facts

Study ID: NCT00501735
Run by: BioCryst Pharmaceuticals
People needed: 144
Starts: 2007-07-01
Expected to finish: 2011-12-01
Last updated by the study team: 2012-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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:
Phototherapy in the previous 30 days;
Electron beam therapy, photopheresis, systemic anticancer therapy, interferon therapy, or other investigational therapy in the previous 30 days;
Oral retinoid (including bexarotene) in the previous 30 days
Alemtuzumab (Campath) or other monoclonal antibody within the previous 30 days
Vorinostat or other HDAC inhibitor within previous 30 days
Any investigational therapy within the previous 30 days;
ALT or AST >3 times ULN or alkaline phosphatase >2 times ULN;
Calculated creatinine clearance ≤50 mL/min or serum creatinine ≥1.8 mg/dL;
Serum potassium <3.3 mg/dL or >5.5 mg/dL;
Evidence of clinically significant (uncontrolled) hypo- or hyperthyroidism;
Recent (in past 6 months) medically significant cardiac event (i.e., myocardial infarction, cardiac surgery);
Presence of congestive heart failure (NYHA class IV) or angina (NYHA class IV) or presence of a medically significant dysrhythmia;
Presence of any of the following ECG findings:
Congenital long QT syndrome;
QTc interval >480 msec (Bazett's correction);
Presence of uncontrolled hypertension manifested by systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥90 mmHg;
Hemoglobin <9.0 gm/dL (intermittent red blood cell transfusions permitted);
Absolute neutrophil count <1500 cells/mm3;

Where it is running

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
Duke University Medical Center — Durham, North Carolina, United States
Wake Forest University Health Sceinces, Dept. of Dermatology — Winston-Salem, North Carolina, United States
Gabrail Cancer Center — Canton, Ohio, United States
University Hospitals Case Medical Center, Dept. of Dermatology — Cleveland, Ohio, United States
Hospital at the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Hillman Cancer Ctr., University of Pittsburgh — Pittsburgh, Pennsylvania, United States
M.D. Anderson Cancer Center - Dermatology — Houston, Texas, United States
Seattle Cancer Care Alliance — Seattle, Washington, United States
University of Wisconsin-Madison, Dept of Dermatology — Madison, Wisconsin, United States
Cabrini Hospital — Malvern, Victoria, Australia
Wien — Vienna, Austria
Helsinki — Helsinki, Finland
Hopital Hotel-Dieu — Clermont-Ferrand, France
Creteil — Créteil, France
Montpellier — Montpellier, France

Full record on ClinicalTrials.gov

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