Gemcitabine and Bexarotene in Treating Patients With Progressive or Refractory Stage IB, Stage II, Stage III, or Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma

OBJECTIVES: Primary * Confirm the feasibility and efficacy of the combination of gemcitabine hydrochloride and bexarotene in patients with cutaneous T-cell lymphoma whose disease is no longer controlled by skin-directed therapy and who have had at least one prior systemic therapy. Secondary * Determine the rate of objective disease control as defined by complete response (CR), clinical complete response (CCR), partial response (PR), and stable disease (SD) for 6 months as determined by the Objective Primary Disease Response Evaluation Criteria (OPDREC). * Evaluate the duration and durability of objective disease response (CR, CCR and PR) as determined by OPDREC criteria. * Evaluate time to objective disease response. * Determine the safety of this combination in terms of adverse events, clinical laboratory data, physical examinations, rate of neutropenic fever and sepsis, blood transfusions, and treatment compliance. * Determine the time to objective disease progression. * Determine the time to treatment failure. * Determine change from baseline in Severity-Weighted Assessment Tool (SWAT) value, Erythroderma SWAT value, Pruritus Visual Analogue Scale, and ECOG performance status. * Determine proportion of disease control, response, and progression as determined by RECIST criteria. * Evaluate the proportion of patients with clearing of Sézary cells from the blood and bone marrow. * Measure changes in patient assessed Quality of Life using Skindex 29 and EORTC QLQ-30. OUTLINE: This is a multicenter study. Patients receive gemcitabine hydrochloride IV on days 1 and 8 and oral bexarotene daily on days 1-21. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses of study therapy, patients with responding disease receive oral bexarotene alone daily until disease progression or treatment no longer tolerated. Patients complete a quality of life questionnaire at baseline, during study therapy, and after completion of study treatment. After completion of study treatment, patients are followed every 2 months for up to 5 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK