Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251368
Status:
COMPLETED
Last Update Posted:
2011-03-10
First Post:
2005-11-08
Brief Title:
Multicenter Study of 9-Aminocamptothecin 9-AC in Patients With Refractory Leukemia
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Multicenter Study of 9-AC in Refractory Leukemia
Status:
COMPLETED
Status Verified Date:
2011-03
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:
The purpose of this study is to evaluate the side effects of 9-Aminocamptothecin 9-AC and to determine the best dose which should be used to treat leukemia
Detailed Description:
The treatment patients will receive involves a continuous infusion of 9-AC intravenously for a 72 hour period Since we are unsure of the safest and most effective dose successive groups of 4-7 patients will receive larger doses of this drug until the largest dose given safely is established
Prior to the start of therapy a bone marrow aspirate and biopsy will be taken for diagnostic and research purposes A bone marrow exam will be repeated at 48 hours in order to determine the effects of 9-AC on leukemic cells in the bone marrow A bone marrow scan will also be performed 14 days after the start of therapy to assess response
Frequent blood testing will be done throughout treatment including blood samples to determine the levels of the 9-AC in the blood
Treatment could be stopped prematurely if any of the following occur 1 drug causes severe side effects 2 the drug does not control the leukemia or 3 the doctors or the patient feel that it is no longer in the patients best interest to receive this therapy
Approximately 7 days after the conclusion of the 9-AC infusion it is likely that the patients blood counts will be low and will require support with antibiotics red cell transfusions and platelet transfusions
Prior to the start of therapy a bone marrow aspirate and biopsy will be taken for diagnostic and research purposes A bone marrow exam will be repeated at 48 hours in order to determine the effects of 9-AC on leukemic cells in the bone marrow A bone marrow scan will also be performed 14 days after the start of therapy to assess response
Frequent blood testing will be done throughout treatment including blood samples to determine the levels of the 9-AC in the blood
Treatment could be stopped prematurely if any of the following occur 1 drug causes severe side effects 2 the drug does not control the leukemia or 3 the doctors or the patient feel that it is no longer in the patients best interest to receive this therapy
Approximately 7 days after the conclusion of the 9-AC infusion it is likely that the patients blood counts will be low and will require support with antibiotics red cell transfusions and platelet transfusions
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