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
18 Years
N/A
Both
Lymphoma
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Federal Government
Study ID:
CDR0000405886
NCT ID:
NCT00098332
Start Date:
November 2004
Completion Date:
Related Keywords:
- Lymphoma
- 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
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
Name | Location |
|---|---|
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
| Yale Cancer Center | New Haven, Connecticut 06520-8028 |
| Dana-Farber/Brigham and Women's Cancer Center | Boston, Massachusetts 02115 |
| Stanford Comprehensive Cancer Center - Stanford | Stanford, California 94305 |
| Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham | Birmingham, Alabama 35294 |
| University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
| Burke Pharmaceutical Research | Hot Springs, Arkansas 71913 |
| Cancer and Blood Disease Center | Lecanto, Florida 34461 |
