Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia
Condition: Chronic Myeloproliferative Disorders; Leukemia; Myelodysplastic Syndromes; Thrombocytopenia
MeSH terms: Leukemia; Preleukemia; Myelodysplastic Syndromes; Thrombocytopenia; Myeloproliferative Disorders; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to
      give higher doses of chemotherapy drugs and kill more cancer cells. Isotretinoin may help
      cancer cells develop into normal white blood cells.

      PURPOSE: Phase I/II trial of topotecan, fludarabine, cytarabine, and filgrastim followed by
      peripheral stem cell transplantation or isotretinoin in treating patients who have acute
      myeloid leukemia, myelodysplastic syndrome, or recurrent or refractory acute lymphocytic
      leukemia.
    

Detailed description: 
      OBJECTIVES: I. Determine the safety of topotecan in combination with fludarabine, cytarabine,
      and filgrastim (FLAG) in patients with poor prognosis acute myeloid leukemia, myelodysplastic
      syndrome, or recurrent or refractory acute lymphocytic leukemia. II. Determine the maximum
      tolerated dose of topotecan in the FLAG regimen in these patients. III. Assess the complete
      remission rates in patients treated with this regimen.

      OUTLINE: Patients with complete response proceed to further therapy according to age. 65 and
      under: Patients receive etoposide by IV continuously for 5 days, cytarabine IV over 2 hours
      every 12 hours for 4 days, and filgrastim (G-CSF) subcutaneously. Peripheral blood stem cells
      (PBSC) are then harvested. Patients then receive oral busulfan every 6 hours on days -7 to -4
      and etoposide IV over 10 hours on day -3. PBSC are reinfused on day 0. Over 65: Patients
      receive oral isotretinoin and vitamin E daily. Treatment continues in the absence of disease
      progression or unacceptable toxicity. Patients are followed every month for 1 year and then
      every 3 months thereafter.

      PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 3-4 years.
    

Intervention name(s): filgrastim; vitamin E; busulfan; cytarabine; etoposide; fludarabine phosphate; isotretinoin; topotecan hydrochloride; bone marrow ablation with stem cell support; peripheral blood stem cell transplantation
Intervention type(s): Biological; Dietary Supplement; Drug; Drug; Drug; Drug; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Vitamin E; Cytarabine; Fludarabine; Fludarabine phosphate; Etoposide; Busulfan; Topotecan; Isotretinoin
Primary purpose: Treatment
Keywords: recurrent adult acute myeloid leukemia; recurrent adult acute lymphoblastic leukemia; relapsing chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; polycythemia vera; primary myelofibrosis; refractory anemia; refractory anemia with ringed sideroblasts; refractory anemia with excess blasts; chronic myelomonocytic leukemia; secondary acute myeloid leukemia; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; thrombocytopenia