Gemcitabine and Mitoxantrone in Treating Patients With Relapsed Acute Myeloid Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Gemcitabine Hydrochloride; Mitoxantrone Hydrochloride
Intervention description: 10 mg/m2/ min IV for 12 hours; 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3
Intervention MeSH terms: Gemcitabine; Mitoxantrone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); recurrent adult acute myeloid leukemia; adult acute minimally differentiated myeloid leukemia (M0); adult acute myeloblastic leukemia without maturation (M1); adult acute myeloblastic leukemia with maturation (M2); adult acute myelomonocytic leukemia (M4); adult acute monoblastic leukemia (M5a); adult acute monocytic leukemia (M5b); adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b); adult acute megakaryoblastic leukemia (M7)

Summary:

      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and mitoxantrone, work in
      different ways to stop the growth of cancer cells, either by killing the cells or by stopping
      them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer
      cells.

      PURPOSE: This phase II trial is studying how well giving gemcitabine together with
      mitoxantrone works in treating patients with relapsed acute myeloid leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Bone marrow examination or peripheral blood analysis confirming active acute myeloid
             leukemia by WHO criteria

               -  No M3 acute myeloid leukemia

          -  Not a candidate for allogenic bone marrow transplantation

          -  Patient must be in first relapse after having received induction chemotherapy

               -  Received 1 or 2 courses with remission lasting at least 1 month

          -  Patients with chloromas or leukemia cutis are eligible

          -  No evidence of leptomeningeal involvement

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

          -  Liver enzymes (total bilirubin, aspartate aminotransferase (AST) and ALT) ≤ 2.5 times
             the upper limits of normal

               -  Liver enzymes ≥ 2.5 are acceptable if physician documents that it is secondary to
                  the disease

          -  Serum creatinine ≤ 3 mg/dL

          -  No poorly controlled medical conditions that would seriously complicate compliance
             with this study

          -  No other active primary malignancy other than carcinoma in situ of the cervix or basal
             cell carcinoma of the skin

          -  No New York Heart Association grade III or IV cardiac problems, defined as congestive
             heart failure or myocardial infarction within 6 months prior to start of study

          -  Pregnant or nursing women are ineligible

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after study
             participation

          -  No documented history of human immunodeficiency virus (HIV) infection

          -  No history of chronic liver disease

          -  Ejection fraction ≥ 45%

          -  No significant history of non-compliance to medical regimens or inability to give
             reliable informed consent

        PRIOR CONCURRENT THERAPY:

          -  Previous treatment related toxicities should be resolved to grade 1 or better

          -  No other investigational agents within 14 days prior to the start of study

          -  No chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to
             start of study

          -  No major surgery within 2 weeks prior to start of study

          -  At least two weeks must have elapsed since the conclusion of radiation therapy and the
             start of gemcitabine hydrochloride, provided the acute effects of radiation treatment
             have been resolved