Lymphoma
Conditions
Keywords
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
Brief 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.
Detailed 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.
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 (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
Countries
United States
Outcome results
None listed