- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00098332
Forodesine (BCX-1777) in Treating Patients With Refractory Stage IIA, Stage IIB, Stage III, Stage IVA, or Stage IVB Cutaneous T-Cell Lymphoma
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
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.
Study Overview
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.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
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Arkansas
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Hot Springs, Arkansas, United States, 71913
- Burke Pharmaceutical Research
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California
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Stanford, California, United States, 94305
- Stanford Comprehensive Cancer Center - Stanford
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Cancer Center at UC Health Sciences Center
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Connecticut
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New Haven, Connecticut, United States, 06520-8028
- Yale Cancer Center
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Florida
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Lecanto, Florida, United States, 34461
- Cancer and Blood Disease Center
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber/Brigham and Women's Cancer Center
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, United States, 45219
- Charles M. Barrett Cancer Center at University Hospital
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Texas
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Houston, Texas, United States, 77030-4009
- M.D. Anderson Cancer Center at University of Texas
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Masking: NONE
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- stage II cutaneous T-cell non-Hodgkin lymphoma
- stage II mycosis fungoides/Sezary syndrome
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIOCRYST-BCX1777-C-04-105
- CDR0000405886 (REGISTRY: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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