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
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.
Primary Purpose: Treatment
Emmanuel C. Besa, MD
Drexel University College of Medicine
United States: Federal Government
|Medical College of Pennsylvania||Philadelphia, Pennsylvania 19129|
|Medical College of Pennsylvania Hospital||Philadelphia, Pennsylvania 19129|