Status:
COMPLETED
Forodesine (BCX-1777) in Treating Patients With Refractory Stage IIA, Stage IIB, Stage III, Stage IVA, or Stage IVB Cutaneous T-Cell Lymphoma
Lead Sponsor:
BioCryst Pharmaceuticals
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 pati...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00098332
Start Date
November 1 2004
End Date
July 1 2011
Last Update
July 10 2013
Active Locations (10)
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1
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
2
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
3
Stanford Comprehensive Cancer Center - Stanford
Stanford, California, United States, 94305
4
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045