Forodesine (BCX-1777) in Treating Patients With Refractory Stage IIA, Stage IIB, Stage III, Stage IVA, or Stage IVB Cutaneous T-Cell Lymphoma
NCT ID: NCT00098332
Last Updated: 2013-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
2004-11-30
2011-07-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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forodesine hydrochloride
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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BioCryst Pharmaceuticals
INDUSTRY
Locations
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Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
Birmingham, Alabama, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Stanford Comprehensive Cancer Center - Stanford
Stanford, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Cancer and Blood Disease Center
Lecanto, Florida, United States
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Countries
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Other Identifiers
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CDR0000405886
Identifier Type: REGISTRY
Identifier Source: secondary_id
BIOCRYST-BCX1777-C-04-105
Identifier Type: -
Identifier Source: org_study_id
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