Bexarotene and GM-CSF in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

This is an interventional treatment trial for Leukemia focused on measuring refractory anemia with excess blasts, recurrent adult acute myeloid leukemia, untreated adult acute myeloid leukemia, secondary acute myeloid leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, myelodysplastic/myeloproliferative disease, unclassifiable, refractory anemia with ringed sideroblasts, refractory cytopenia with multilineage dysplasia, chronic myelomonocytic leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, 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 pure erythroid leukemia (M6b), adult erythroleukemia (M6a), adult acute megakaryoblastic leukemia (M7), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with inv(16)(p13;q22) Read More

DISEASE CHARACTERISTICS:

• Diagnosis (confirmed by bone marrow aspirate and/or biopsy) of 1 of the following:

  • Myelodysplastic syndromes of 1 of the following cell types:

    • Refractory anemia (RA) with ringed sideroblasts
    • Refractory cytopenia with multilineage dysplasia (RCMD)
    • RCMD and ringed sideroblasts
    • RA with excess blasts-1
    • RA with excess blasts-2
    • Myelodysplastic syndromes, unclassified
    • Chronic myelomonocytic leukemia

  • Relapsed or refractory acute myeloid leukemia (AML), meeting 1 of the following criteria:

    • Recurrent genetic abnormalities (11q23 [MLL] abnormalities)
    • Multilineage dysplasia
    • Therapy-related AML

    • Not otherwise categorized, including any of the following:

      • M0 minimally differentiated
      • M1 without maturation
      • M2 with maturation
      • M4 myelomonocytic leukemia
      • M5 monoblastic/monocytic leukemia
      • M6 erythroid leukemia
      • M7 megakaryoblastic leukemia
• Newly diagnosed untreated AML allowed provided patient does not qualify for or refused potentially curative intensive chemotherapeutic regimens
• No RA with 5q-syndrome
• No peripheral leukemia with blast count > 30,000/mm³ (uncontrolled with hydroxyurea)
• Relatively stable bone marrow function for > 7 days (i.e., no WBC doubling to > 10,000/mm^3)
• No acute promyelocytic leukemia
• No clinical symptoms of active CNS disease (if CNS disease is suspected, patient must have lumbar puncture with negative cytology)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Creatinine ≤ 2.0 mg/dL
• Bilirubin ≤ 1.6 mg/dL (unless secondary to hemolysis)
• AST and ALT ≤ 4 times upper limit of normal (unless disease related)
• Hemoglobin ≥ 8 g/dL (transfusions allowed)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception
• No untreated positive blood cultures or progressive infection as assessed by radiographic studies
• No history of intolerance to sargramostim (GM-CSF)

PRIOR CONCURRENT THERAPY:

• Recovered from prior therapy

• At least 2 weeks since prior treatment for myeloid disorder, including any of the following:

  • Chemotherapy
  • Hematopoietic growth factors
  • Biologic therapy (e.g., monoclonal antibodies)
• Hydroxyurea for patients with WBC > 10,000/mm^3 allowed
• No concurrent vitamin A supplementation
• No concurrent gemfibrozil