Forodesine (BCX-1777) in Treating Patients With Refractory Stage IIA, Stage IIB, Stage III, Stage IVA, or Stage IVB Cutaneous T-Cell Lymphoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: forodesine hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: forodesine hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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