Liposomal Doxorubicin Followed By Bexarotene in Treating Patients With Cutaneous T-Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Cutaneous
Intervention: Targretin® (bexarotene); pegylated liposomal doxorubicin hydrochloride
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Bexarotene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: 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 cutaneous T-cell non-Hodgkin lymphoma; stage I mycosis fungoides/Sezary syndrome; stage II mycosis fungoides/Sezary syndrome; stage III mycosis fungoides/Sezary syndrome; stage IV mycosis fungoides/Sezary syndrome; recurrent mycosis fungoides/Sezary syndrome

Summary:

      RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and bexarotene, work in
      different ways to stop the growth of cancer cells, either by killing the cells or by stopping
      them from dividing. Bexarotene may also cause cutaneous T-cell lymphoma cells to look more
      like normal cells, and to grow and spread more slowly. Giving liposomal doxorubicin followed
      by bexarotene may be an effective treatment for cutaneous T-cell lymphoma.

      PURPOSE: This phase II trial is studying how well giving liposomal doxorubicin followed by
      bexarotene works in treating patients with cutaneous T-cell lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed cutaneous T-cell lymphoma

               -  Stage IB-IV disease

          -  Measurable disease

          -  Newly diagnosed or previously treated disease

               -  No demonstrated resistance to prior bexarotene

        PATIENT CHARACTERISTICS:

        Performance status

          -  Karnofsky 60-100%

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  AST and ALT ≤ 2.5 times upper limit of normal (ULN)

          -  Bilirubin < 1.5 times ULN

        Renal

          -  Creatinine ≤ 1.5 times ULN

        Cardiovascular

          -  Ejection fraction ≥ 50% by MUGA or 2-D echocardiogram

          -  No New York Heart Association class II-IV heart disease

          -  No clinical evidence of congestive heart failure

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 4 weeks after
             completion of study treatment

          -  No history of hypersensitivity reactions attributed to doxorubicin HCl liposome or its
             components

          -  No active potentially life-threatening infection

          -  No other acute disease

        PRIOR CONCURRENT THERAPY:

        Chemotherapy

          -  See Disease Characteristics

          -  Prior doxorubicin allowed provided the cumulative dose is ≤ 300 mg/m^2

          -  Prior epirubicin hydrochloride allowed provided the cumulative dose is ≤ 540 mg/m^2