BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma

Study Overview
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Brief Summary
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RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase I/II trial to study the effectiveness BCX-1777 in treating patients who have refractory cutaneous T-cell lymphoma.

Detailed Description
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OBJECTIVES: Determine the maximum tolerated dose of BCX-1777 in patients with refractory cutaneous T-cell lymphoma. Determine the efficacy of this drug in these patients. Determine the toxicity profile of this drug in these patients. Correlate plasma concentration of deoxyguanosine with clinical response and toxicity in patients treated with this drug. Determine the provisional optimal biological dose of this drug in these patients. OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study. Phase I: Patients receive BCX-1777 IV over 30 minutes every 12 hours on days 1-5 (a total of 9 doses). Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BCX-1777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity. Phase II: Patients receive treatment as in phase I at the MTD of BCX-1777. Patients (including those who respond to treatment) are followed at 14 and 30 days, monthly for 6 months, every 2 months for 6 months, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 3-64 patients (3-24 for phase I and 40 for phase II) will be accrued for this study.

Official Title
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Phase 1-2 Multi-Center Study of Intravenous BCX-1777 in Patients With Refractory Cutaneous T-Cell Lymphoma (CTCL)

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 (CTCL) Any stage except IA patch only Previously treated according to 1 of the following: Stage IA plaque, IB, or IIA: At least 4 prior conventional and/or experimental regimens (topical or systemic, including psoralen-ultraviolet light [PUVA] and systemic corticosteroids) Stage IIB, III, or IV: At least 1 prior systemic regimen (systemic corticosteroids and PUVA do not count as systemic regimens for this purpose) NOTE: Repeated use of the same regimen is considered one regimen Measurable disease PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-3 Life expectancy At least 3 months Hematopoietic Granulocyte count at least 2,000/mm^3 Platelet count at least 75,000/mm^3 Hemoglobin at least 10.0 g/dL Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) (unless due to Gilbert's syndrome) ALT no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN No hepatitis B or C Renal Creatinine clearance at least 45 mL/min Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative Human T-cell leukemia virus type 1 (HTLV-1) negative No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No other illness that would limit study participation No active serious infection not controlled by antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent anticancer antibody therapy No concurrent anticancer immunotherapy No concurrent anticancer gene therapy No concurrent anticancer vaccine therapy No concurrent anticancer angiogenesis inhibitors No concurrent sargramostim (GM-CSF) No concurrent filgrastim (G-CSF) during course 1 of therapy Chemotherapy More than 21 days since prior chemotherapy unless fully recovered No concurrent anticancer chemotherapy Endocrine therapy See Disease Characteristics More than 2 weeks since prior topical corticosteroids No concurrent anticancer hormonal therapy Radiotherapy More than 2 weeks since prior radiotherapy No concurrent radiotherapy Surgery Not specified Other More than 2 weeks since prior antineoplastic therapy More than 21 days since prior investigational agents unless fully recovered No concurrent citrate-blood products within 30 minutes before or after study treatment No concurrent anticancer matrix metalloprotease inhibitors No other concurrent anti-CTCL therapy No concurrent use of tanning beds No other concurrent investigational agents

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 I 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 I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome