Non Hodgkin Lymphoma Clinical Trial
BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma
Summary
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.
Full Description
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.
Eligibility Criteria
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
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There are 3 Locations for this study
Birmingham Alabama, 35294, United States
Durham North Carolina, 27710, United States
Houston Texas, 77030, United States
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