Gemcitabine and Pemetrexed Disodium in Treating Patients With Advanced Mycosis Fungoides or Sézary Syndrome
Condition: Lymphoma
MeSH terms: Mycoses; Lymphoma; Mycosis Fungoides; Sezary Syndrome
Intervention: Gemcitabine; Pemetrexed
Intervention description: Patients will be treated in cohorts of 3-6 per cohort. The starting dose of gemcitabine will be 800 mg/m^2 given as an intravenous (IV) infusion on days 1 and 15 of each 28-day cycle. The dose will be escalated for each subsequent cohort of patients, up to a maximum of 1200 mg/m^2.; Patients will be treated in cohorts of 3-6 per cohort. The starting dose of pemetrexed will be 400 mg/m^2 given as an intravenous (IV) infusion on days 1 and 15 of each 28-day cycle. The dose will be escalated for each subsequent cohort of patients, up to a maximum of 500 mg/m^2.
Intervention MeSH terms: Gemcitabine; Pemetrexed
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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; 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

Summary:

      RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop
      the growth of cancer cells, either by killing the cells or by stopping them from dividing.
      Pemetrexed disodium may stop the growth of cancer cells by blocking some of the enzymes
      needed for cell growth. Giving gemcitabine together with pemetrexed disodium may kill more
      cancer cells.

      PURPOSE: This was planned as a phase I/II trial studying the side effects and determining the
      best dose of gemcitabine hydrochloride when given together with pemetrexed disodium.
      Unfortunately, due to a lack of funding, the phase II portion was never conducted.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed* mycosis fungoides or Sézary syndrome

               -  Stage IB-IVB disease NOTE: *Pathology report must read diagnostic or consistent
                  with mycosis fungoides/Sézary syndrome

          -  Failed ≥ 1 prior systemic treatment

          -  Measurable disease

               -  At least 1 indicator lesion must be designated prior to study entry

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Life expectancy ≥ 6 months

          -  Creatinine ≤ 2.0 mg/dL

          -  Creatinine clearance ≥ 45 mL/min

          -  Bilirubin ≤ 2.2 mg/dL

          -  AST and ALT ≤ 2 times upper limit of normal

          -  WBC ≥ 3,000/mm³

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  No acute infection requiring systemic treatment

          -  No history of severe hypersensitivity reaction to the study drugs or to any other
             ingredient used in their formulation

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 4 weeks since prior topical therapy, systemic chemotherapy, or biological
             therapy

          -  No acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs) for 2
             days before and for 2 days after pemetrexed disodium infusion (5 days before and for 2
             days after pemetrexed disodium infusion for patients taking NSAIDs with a long
             half-life [e.g., naproxen, refocoxib, or celecoxib])

          -  No concurrent topical agents except emollients

          -  No other concurrent topical or systemic anticancer therapies

          -  No other concurrent investigational agents