Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003619
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia Myelodysplastic Syndrome or Acute Lymphocytic Leukemia
Sponsor:
Drexel University College of Medicine
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Combination Study of Topotecan Fludarabine Cytosine Arabinoside and G-CSF T-FLAG Induction Therapy in Patients With Poor Prognosis AML MDS and RelapsedRefractory ALL Followed by Maintenance of Either PBSC Transplant or 13 Cis-Retinoic Acid
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 III 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
PURPOSE Phase III 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V98-1485 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066698 | REGISTRY | None | None |
| AUH-MCP-70612-02P | None | None | None |