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Forodesine (BCX-1777) in Treating Patients With Refractory Stage IIA, Stage IIB, Stage III, Stage IVA, or Stage IVB Cutaneous T-Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00098332
Recruitment Status : Completed
First Posted : December 8, 2004
Last Update Posted : July 10, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Forodesine (BCX-1777) may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

PURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have refractory stage IIA, stage IIB, stage III, stage IVA, or stage IVB cutaneous T-cell lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: forodesine hydrochloride Phase 1

Detailed Description:


  • Determine the safety and efficacy of forodesine (BCX-1777) in patients with refractory stage IIA-IVB cutaneous T-cell lymphoma.
  • Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral forodesine (BCX-1777) once daily on days 1-28. Courses may be repeated in the absence of disease progression or unacceptable toxicity.

Patients are followed periodically.


Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Multi-Center, Open-Label, Safety and Pharmacokinetic, Repeat-Dose Study of Oral Forodesine Hydrochloride in Patients With Refractory Cutaneous T-Cell Lymphoma
Study Start Date : November 2004
Primary Completion Date : December 2010
Study Completion Date : July 2011

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed cutaneous T-cell lymphoma

    • Refractory to prior treatment
    • Stage IIA, IIB, III, IVA, or IVB disease
  • Measurable disease



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months


  • Not specified


  • AST and/or ALT ≤ 3 times upper limit of normal
  • Hepatitis B and/or hepatitis C negative


  • Creatinine clearance ≥ 40 mL/min


  • Human T-cell lymphotrophic virus type I (HTLV-I) negative
  • HIV negative
  • No active serious infection not controlled by antibiotics


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known impaired absorption of the gastrointestinal tract
  • No other illness that would preclude study participation


Biologic therapy

  • Not specified


  • More than 21 days since prior chemotherapy and recovered

Endocrine therapy

  • Concurrent topical corticosteroids allowed provided patient remains on a stable dose


  • No concurrent radiotherapy


  • Not specified


  • More than 30 days since prior investigational agents and recovered
  • No concurrent tanning bed use
  • No other concurrent therapy for cutaneous T-cell lymphoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00098332

United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
United States, California
Stanford Comprehensive Cancer Center - Stanford
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, Florida
Cancer and Blood Disease Center
Lecanto, Florida, United States, 34461
United States, Massachusetts
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States, 02115
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Ohio
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45219
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
BioCryst Pharmaceuticals

ClinicalTrials.gov Identifier: NCT00098332     History of Changes
Other Study ID Numbers: BIOCRYST-BCX1777-C-04-105
CDR0000405886 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: December 8, 2004    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: June 2007

Keywords provided by National Cancer Institute (NCI):
recurrent cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin