NCT00003619

Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Drexel University College of Medicine · Academic / Other
• Sex: All
• Age: 19 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Myeloproliferative Disorders
• Leukemia
• Myelodysplastic Syndromes
• Thrombocytopenia

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DIETARY_SUPPLEMENT	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

Timeline

• Start date: 1998-02-01
• Completion: 2004-04-01
• First posted: 2004-04-27
• Last updated: 2013-06-26

Locations

2 sites across 1 country: United States