Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040105
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2002-06-19
Brief Title:
Zarnestra and Gleevec in Chronic Phase Chronic Myelogenous Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Study of Zarnestra R115777USA30 and Gleevec Imatinib Mesylate in Chronic Phase Chronic Myelogenous Leukemia CML
Status:
COMPLETED
Status Verified Date:
2012-07
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 goal of this clinical research study is to find the highest safe dose of the drugs ZarnestraTM R115777 and Gleevec imatinib mesylate that can be given in combination for the treatment of chronic myelogenous leukemia CML in chronic phase The effect of this combination on the leukemia will also be studied
Detailed Description:
R115777 is a new drug that blocks the function of an enzyme that is important in making some proteins work One of the most important targets for this enzyme is a protein that can make cells become cancer Imatinib mesylate is a drug that blocks the function of the protein that comes from the Philadelphia chromosome The Philadelphia chromosome is an abnormality in chromosomes 9 and 22 that changes blood cells into leukemia cells
Before treatment starts participants will have a physical exam blood tests About 3 tubes 2 teaspoons each and a bone marrow biopsy The bone marrow will be removed with a large needle
Participants in this study will take imatinib mesylate by mouth every day for as long as they stay on study which means as long as it works Participants will also take R115777 twice a day for 2 weeks This will be repeated every 3 weeks The amount of each of these medications that participants take will depend on when they enter the study The doses will be slowly increased from participant to participant until the highest dose that does not cause serious side effects is found
Participants will be asked to visit their doctor for a physical exam and measurement of vital signs The frequency of doctor visits will vary depending on physical condition Blood tests about 2 teaspoons each will be done every week during the first 3 weeks of treatment Blood tests will then be done every 8-12 weeks for the length of the study as needed The blood samples will be used for routine lab tests A bone marrow sample will also be taken to check and measure cells related to the disease every 3 months in the first year and then every 6-12 months Participants can stay on study for as long as the treatment is considered to be beneficial Participants will be taken off study if their disease gets worse or intolerable side effects occur
This is an investigational study The FDA has authorized the use of imatinib mesylate for patients with CML It is the combination of imatinib mesylate and R115777 that is experimental R115777 has been authorized for investigational use only A maximum of 30 patients will take part in this study All will be enrolled at M D Anderson
Before treatment starts participants will have a physical exam blood tests About 3 tubes 2 teaspoons each and a bone marrow biopsy The bone marrow will be removed with a large needle
Participants in this study will take imatinib mesylate by mouth every day for as long as they stay on study which means as long as it works Participants will also take R115777 twice a day for 2 weeks This will be repeated every 3 weeks The amount of each of these medications that participants take will depend on when they enter the study The doses will be slowly increased from participant to participant until the highest dose that does not cause serious side effects is found
Participants will be asked to visit their doctor for a physical exam and measurement of vital signs The frequency of doctor visits will vary depending on physical condition Blood tests about 2 teaspoons each will be done every week during the first 3 weeks of treatment Blood tests will then be done every 8-12 weeks for the length of the study as needed The blood samples will be used for routine lab tests A bone marrow sample will also be taken to check and measure cells related to the disease every 3 months in the first year and then every 6-12 months Participants can stay on study for as long as the treatment is considered to be beneficial Participants will be taken off study if their disease gets worse or intolerable side effects occur
This is an investigational study The FDA has authorized the use of imatinib mesylate for patients with CML It is the combination of imatinib mesylate and R115777 that is experimental R115777 has been authorized for investigational use only A maximum of 30 patients will take part in this study All will be enrolled at M D Anderson
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