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A Phase I/II Combination Study of Topotecan, Fludarabine, Cytosine Arabinoside and G-CSF (T-FLAG) Induction Therapy in Patients With Poor Prognosis AML, MDS and Relapsed/Refractory ALL Followed by Maintenance of Either PBSC Transplant or 13 Cis-Retinoic Acid (NCT00003619)

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.
  • Biological: filgrastim
    • : vitamin E
      • Drug: busulfan
        • Drug: cytarabine
          • Drug: etoposide
            • Drug: fludarabine phosphate
              • Drug: isotretinoin
                • Drug: topotecan hydrochloride
                  • Procedure: bone marrow ablation with stem cell support
                    • Procedure: peripheral blood stem cell transplantation
                      Ages eligible for Study
                      19 Years to 90 Years
                      Genders eligible for Study
                      Accepts Healthy Volunteers
                      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.

                      2 locations

                      United States (2)
                      • Medical College of Pennsylvania Hospital
                        Not specified
                        Philadelphia, Pennsylvania, United States, 19129
                      • Medical College of Pennsylvania
                        Not specified
                        Philadelphia, Pennsylvania, United States, 19129
                      Ⅰ, Ⅱ
                      31 January, 1998
                      24 June, 2013
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