BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring 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
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
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- Duke Comprehensive Cancer Center
- University of Texas - MD Anderson Cancer Center