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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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00098332
First received: December 7, 2004
Last updated: July 9, 2013
Last verified: June 2007
  Purpose

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 Intervention Phase
Lymphoma
Drug: forodesine hydrochloride
Phase 1

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


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

Study Start Date: November 2004
Study Completion Date: July 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

PROJECTED ACCRUAL: Not specified.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed cutaneous T-cell lymphoma

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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months

Hematopoietic

  • Not specified

Hepatic

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

Renal

  • Creatinine clearance ≥ 40 mL/min

Immunologic

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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • More than 21 days since prior chemotherapy and recovered

Endocrine therapy

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

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • More than 30 days since prior investigational agents and recovered
  • No concurrent tanning bed use
  • No other concurrent therapy for cutaneous T-cell lymphoma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098332

Locations
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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00098332     History of Changes
Other Study ID Numbers: BIOCRYST-BCX1777-C-04-105, CDR0000405886
Study First Received: December 7, 2004
Last Updated: July 9, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on November 20, 2014