Forodesine in the Treatment of Cutaneous T-Cell Lymphoma

NCT00501735 | Completed Phase 2 DMC

• 1 other identifier: BCX1777-203
• Study Type: interventional
• Target: 144
• Locations: 9 countries
• Sites: 40

Brief 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.

Conditions

Cutaneous T-cell Lymphoma (CTCL),

Keywords

T-Cell; Lymphoma; Forodesine; Mycosis Fungoides

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to determine the objective response rate to treatment with oral forodesine in subjects with cutaneous manifestations of CTCL subjects, stages IIB, III, and IVA.

  Duration of Study

Secondary Outcomes (5)

• Safety and tolerability

  Duration of Study

• Time to and duration of objective response in cutaneous manifestations

  Duration of Study

• Time to loss of objective response

  Duration of Study

• Objective response rate, time to and duration of extracutaneous manifestations

  Duration of Study

• Health related quality of life

  Duration of Study

Interventions

Forodesine 200 mg DRUG

2 x 100mg tablets once daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• BioCryst Pharmaceuticals: lead

Study Sites (41)

University of Alabama at Birmingham, Comprehensive Cancer Ctr

Birmingham, Alabama, 35294-3300, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

LSU Health Sciences Center, Feist-Weiller Cancer Center

Shreveport, Louisiana, 71103, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Ctr

Hackensack, New Jersey, 07601, United States

Location

Upstate Medical University

Syracuse, New York, 13210, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University Health Sceinces, Dept. of Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

University Hospitals Case Medical Center, Dept. of Dermatology

Cleveland, Ohio, 44106, United States

Location

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Hillman Cancer Ctr., University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

M.D. Anderson Cancer Center - Dermatology

Houston, Texas, 77030, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 89109, United States

Location

University of Wisconsin-Madison, Dept of Dermatology

Madison, Wisconsin, 53715, United States

Location

Cabrini Hospital

Malvern, Victoria, 3144, Australia

Location

Wien

Vienna, 1090, Austria

Location

Helsinki

Helsinki, FIN-00029 HUS, Finland

Location

Hopital Hotel-Dieu

Clermont-Ferrand, 63058, France

Location

Creteil

Créteil, 94000, France

Location

Montpellier

Montpellier, 34295, France

Location

Pessac

Pessac, 33600, France

Location

CHU Robert Debre

Reims, 51092, France

Location

Toulouse

Toulouse, 31059, France

Location

Campus Charité Mitte

Berlin, D10117, Germany

Location

Universitatsklinikum Jena

Jena, 07740, Germany

Location

Universitat Kiel

Kiel, 24105, Germany

Location

Klinik fur Dermatologie, Venerologie und Allergologie

Mannheim, 68163, Germany

Location

Bologna

Bologna, 40138, Italy

Location

Firenze

Florence, 50121, Italy

Location

Milan

Milan, 20122, Italy

Location

Rome

Rome, 00167, Italy

Location

Torino

Torino, 10126, Italy

Location

Madrid

Madrid, 28041, Spain

Location

Zurich

Zurich, CH-8091, Switzerland

Location

London

London, SE1 7EH, United Kingdom

Location

Manchester

Manchester, M20 4BX, United Kingdom

Location

Related Publications (1)

• Dummer R, Duvic M, Scarisbrick J, Olsen EA, Rozati S, Eggmann N, Goldinger SM, Hutchinson K, Geskin L, Illidge TM, Giuliano E, Elder J, Kim YH. Final results of a multicenter phase II study of the purine nucleoside phosphorylase (PNP) inhibitor forodesine in patients with advanced cutaneous T-cell lymphomas (CTCL) (Mycosis fungoides and Sezary syndrome). Ann Oncol. 2014 Sep;25(9):1807-1812. doi: 10.1093/annonc/mdu231. Epub 2014 Jun 19.

  PMID: 24948692 DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Lymphoma; Mycosis Fungoides

Interventions

forodesine

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Nashat Gabrail, MD

  Gabrail Cancer Center

  PRINCIPAL INVESTIGATOR

• Madeleine Duvic, MD

  M.D. Anderson Cancer Center - Dermatology

  PRINCIPAL INVESTIGATOR

• Youn Kim, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Andres Forero-Torres, M.D.

  University of Alabama at Birmingham, Comprehensive Cancer Ctr.

  PRINCIPAL INVESTIGATOR

• Alan B Fleischer, Jr., MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Gary S. Wood, MD

  University of Wisconsin-Madison, Dept of Dermatology

  PRINCIPAL INVESTIGATOR

• Andre Goy, MD

  Hackensack Universeity Medical Ctr

  PRINCIPAL INVESTIGATOR

• Larisa Geskin, MD

  Hillman Cancer Ctr., University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Nancy Bartlett, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Francine Foss, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Miles Prince, MD

  Cabrini Hospital

  PRINCIPAL INVESTIGATOR

• Elise Olsen, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Sareeta S Parker, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Neil J Korman, MD, PhD

  University Hospitals Case Medical Ctr., Dept. of Dermatology

  PRINCIPAL INVESTIGATOR

• Francesco Turturro, MD

  LSU Health Sciences Ctr., Feist-Weiller Cancer Center

  PRINCIPAL INVESTIGATOR

• Andrei R Shustov, MD

  Seattle Cancer Care Alliance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 16, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2011
• Last Updated: January 23, 2012

Record last verified: 2012-01

Locations

ES (1); AU (1); GB (2); FR (6); DE (4); CH (1); US (19); FI (1); IT (5)