drugset / Trial / NCT00003619
Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia
Treatment
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.
Timeline
- Start
- 1998-02
- Primary completion
- —
- Completion
- 2004-04
Publications
- Results Besa E, Maiale C, Liman D, et al.: Early data on a new combination chemotherapy using topotecan, fludarabine, ARA-C and G-CSF for aggressive myelodysplastic syndromes in the elderly. [Abstract] Leuk Res 23 (Suppl 1): A-191, S72, 1999.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | — | Oral |
| Subject | Cytarabine | Small molecule | — | Intravenous |
| Subject | Etoposide | Small molecule | — | Intravenous |
| Subject | Fludarabine | Small molecule | — | — |
| Subject | Isotretinoin | Other / unclassified | — | Oral |
| Subject | Topotecan | Small molecule | — | — |
| Background | filgrastim | Protein / enzyme biologic | — | Subcutaneous |