Lymphoma
Conditions
Keywords
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
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 patients who have refractory stage IIA, stage IIB, stage III, stage IVA, or stage IVB cutaneous T-cell lymphoma.
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.
Interventions
Sponsors
BioCryst Pharmaceuticals
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed